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SURGERY - PROCEDURES, COMPLICATIONS, AND RESULTS MANAGEMENT FOR FAILED BARIATRIC PROCEDURES SURGICAL STRATEGIES JACQUES HIMPENS AND RAMON VILALLONGA EDITORS New York Copyright © 2015 by Nova Science Publishers, Inc. All rights reserved. No part of this book may be reproduced, stored in a retrieval system or transmitted in any form or by any means: electronic, electrostatic, magnetic, tape, mechanical photocopying, recording or otherwise without the written permission of the Publisher. We have partnered with Copyright Clearance Center to make it easy for you to obtain permissions to reuse content from this publication. Simply navigate to this publication‟s page on Nova‟s website and locate the “Get Permission” button below the title description. This button is linked directly to the title‟s permission page on copyright.com. Alternatively, you can visit copyright.com and search by title, ISBN, or ISSN. 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Library of Congress Cataloging-in-Publication Data ISBN: (eBook) Library of Congress Control Number: 2015949937 Published by Nova Science Publishers, Inc. † New York CONTENTS Foreword vii Kelvin Higa Introduction Chapter 1 ix Revisional Bariatric Surgery for Weight Regain: A Programmatic Approach Eric J. DeMaria and Meredith A. Grzybowski 1 Chapter 2 Metabolic Failures and Bariatric Procedures Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen 9 Chapter 3 Diagnostic Tools in Failed Bariatric Procedures Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner 23 Chapter 4 Adjustable Gastric Band Failures J. W. M. Greve 57 Chapter 5 Failed Sleeve Gastrectomy Ricard Corcelles and Antonio Lacy 73 Chapter 6 Reoperations for Roux-en-Y Gastric Bypass Failures Jacques M. Himpens and Ramon Vilallonga 87 Chapter 7 Failed Minigastric Bypass: Surgical Strategies Jean-Marc Chevallier 117 vi Chapter 8 Chapter 9 Index Contents Surgical Procedures for Failure of Biliopancreatic Diversion with Duodenal Switch (BPD-DS) Simon Marceau, Simon Biron, Frédéric-Simon Hould, Stefane Lebel, Odette Lescelleur, Laurent Biertho and Picard Marceau Failed BPD Giuseppe Maria Marinari, Vincenzo Borrelli and Luc Lemmens 139 149 159 FOREWORD The epidemic of obesity continues to challenge health care systems because of its prevalence, chronicity and failure to respond to traditional nonsurgical treatment paradigms. Bariatric surgery has been proven to be safe and effective through randomized controlled trials and long-term cohort studies for BMI reduction, resolution or improvement of metabolic syndrome, quality of life and longevity [1, 2, 3, 4, 5]. Despite the remarkable success of bariatric surgery, the lack of standardization of many of our procedures in combination with the heterogeneity of the disease contributes to long-term complications, recidivism of weight and/or metabolic syndrome [6, 7]. Secondary procedures are sometimes necessary to optimize performance of the original procedure or to convert to a different anatomic construct depending on the response to achieve the desired effect. This is consistent with our ethical values: to provide life-long care for each individual patient. The editors and authors of this book are to be congratulated for their ability to segregate and simplify the complex topic of re-operative bariatric surgery. This is the first-of-its kind guide for both novice and expert surgeons caring for some of the most challenging of patient problems. After reading this book, you will understand that “Failed Bariatric Procedures” is not about the inadequacies of our operations, but the chasm that exists between our understanding of the disease of obesity and the pathophysiology of our interventions [8]. Kelvin Higa, MD, FASMBS REFERENCES [1] Sjöström L, Narbro K, Sjöström CD, et al, and the Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med 2007; 357: 741–52. [2] Adams TD, Gress RE, Smith SC, et al. Long-term mortality after gastric bypass surgery. N Engl J Med 2007; 357: 753–61. [3] Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med 2012; 366: 1567–76. [4] Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med 2012; 366: 1577–85. [5] Dixon JB, O‟Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA 2008; 299: 316–23. [6] Arterburn DE, Bogart A, Sherwood NE, et al. A multisite study of longterm remission and relapse of type 2 diabetes mellitus following gastric bypass. Obes Surg 2013; 23: 93–102. [7] Higa K, Ho T, Tercero F, Yunus T, Boone KB. Laparoscopic Roux- en-Y gastric bypass: 10-year follow-up. Surg Obes Relat Dis 2011;7: 516–25. [8] www.RevisionalBariatrics.com INTRODUCTION Brussels and Barcelona Lectori Salutem, Dear reader of Management for Failed Bariatric Procedures: Surgical Strategies, Before you start reading yet another book on the issue of bariatricmetabolic surgery, we would like to invite you to have a quick glance at the name of the contributors to this composition. You will undoubtedly understand that the editors succeeded in gathering one of the most select group of authors specialized in the field of redo-bariatric surgery. Moreover, we believe that every single contributing author excels in the particular field he/she was asked to treat. This book is meant to be essentially practical, but exhaustive as well to allow the reader to be helped in almost all occasions of revisional weight loss surgery he/she may encounter. The format of the chapters is quite similar throughout to help readers with swift research. The figures and drawings should significantly enlighten the explanations provided in the text. Finally, thanks to the diversity of the subjects, we believe we kept the almost inevitable danger of overlapping subjects to a strict minimum. Remedial surgery becomes increasingly frequent in everyday bariatric practice. This work aims at guiding the expert surgeon through some of the most challenging situations he/she will encounter. We sincerely hope you enjoy reading this book! Jacques Himpens AZ St-Blasius Chief Department Division of Bariatric Surgery Kroonveldlaan 52, 9200 Dendermonde, Belgium. Email: [email protected] Ramon Vilallonga Consultant surgeon University Hospital Vall Hebron. Endocrine, bariatric and metabolic Unit. General Surgery Department. Pg de la Vall Hebron 119-129 08035 Barcelona, Spain Email: [email protected] In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 1 REVISIONAL BARIATRIC SURGERY FOR WEIGHT REGAIN: A PROGRAMMATIC APPROACH Eric J. DeMaria1, MD, and Meredith A. Grzybowski2, ANP 1 Maryview Medical Center, Bon Secours Surgical Specialists Suffolk, Virginia, US 2 Maryview Medical Center, Bon Secours Health System Portsmouth, Virginia, US ABSTRACT Revisional bariatric surgery is a significant endeavor because of higher operative risks and poorer weight loss outcomes than primary procedures. The decision to carry out such surgery must be taken by a multidisciplinary team that confirms that the outcomes of the primary procedure actually are not sufficient and, if this is the case, thoroughly analyzes the causes of failure of the initial procedure. Causes for failure include anatomical factors such as initially poorly performed constructions or, conversely, acquired changes that counteract the activity of a correctly performed surgical procedure. Evaluation of the anatomical imperfection requires specific radiological and endoscopic techniques. Email: [email protected]. Tel: (757) 483-3030. 2 Eric J. DeMaria and Meredith A. Grzybowski Depending on the objective findings in combination with the subjective complaints of the patient an adequate surgical strategy can be searched for. More often than not however behavioral/dietary flaws constitute the essential part of the failure and must be addressed by patient re-education and behavior modification. OVERVIEW Revisional bariatric surgery is a complex and evolving area of traditional bariatric surgery. Although bariatric surgery provides a permanent tool to treat obesity for the majority of patients, we are seeing a growing number return with issues that need to be addressed by multidisciplinary comprehensive treatment strategies. Although there may be surgical options, often the procedures are difficult and often carry greater risk than the primary operation. [1] More importantly, the benefit of the various surgical intervention have not been proven in large cohort studies. Our primary philosophy is to evaluate the patient‟s anatomy while asking the question “does this procedure look like it is supposed to look?” In years past, our approach was different in that we, and many others, considered only major technical complications, like staple line disruption, to be of significance. Now we are considering the patient in a comprehensive manner evaluating their eating behavior and whether or not they still receive feedback from their surgical „tool‟. Patients who do not receive feedback from a primarily restrictive procedure such as gastroplasty, gastric bypass, or gastric banding are considered likely to have anatomic changes that have led to a suboptimal result. This hypothesis is further investigated by endoscopy and imaging studies as well as comprehensive behavioral evaluation. This information is collated and used to discuss treatment strategies and recommend options. It is important to remember that, while bariatric surgery leads to complex physiologic changes including changes in gut hormones such as ghrelin, altered metabolic responses including a cancer-cachexia like syndrome, etc. revisional surgery is not undertaken to restore or augment these responses. Despite experience with many hundreds of revisional procedures, we do not know if these procedures manipulate the physiology. Our focus is on the traditional concepts of how bariatric surgery works, i.e., we manipulate restriction and/or malabsorption. It is important to approach a planned revisional intervention in these terms. Revisional Bariatric Surgery for Weight Regain 3 CANDIDATES Patients seek out revisional bariatric surgery for a multitude of reasons, some because they have regained weight, some because they believe their surgery has failed, and some because they experience physical problems that they believe may be related to having bariatric surgery. [2] What is constant, is that nearly all the patients that come to see the bariatric unit are unsatisfied with their current weight and are looking for help to obtain a certain weight loss goal or improve current comorbidities. We primarily see patients with previous gastric bypass since that procedure has been performed open or laparoscopically in our region of the United States for the past 20 plus years. Therefore most of our review will cover our approach to the struggling gastric bypass patient and how we evaluate them. EDUCATION Patients start the process by calling our program and are scheduled to attend a bariatric revision seminar. They are then sent a packet of information and paperwork to fill out and return. In addition to a health questionnaire and release of medical information form used to obtain the initial surgery operative note, the paperwork they are asked to fill out also contains a revision testimonial in which we ask patients to describe in their own words why they feel they need a revision of their bariatric surgery. Bariatric revision seminars are held once per month and give patients general information on what to expect with the evaluation process, types of testing performed, and surgical and non-surgical options for revisional bariatric surgery such as reversal, revision, conversion, and endoscopic procedures. Patients are also provided with information from our program dietician about the nutritional evaluation and key diet principles that bariatric patients should be aware of and follow. Patients are then scheduled for an initial evaluation with the bariatric surgeon. INITIAL EVALUATION During the initial evaluation appointment we take the patient's past bariatric history including what type of surgery was performed, what the approach was (open or laparoscopic), when the surgery was done, and who 4 Eric J. DeMaria and Meredith A. Grzybowski performed the surgery. We also want to know what their initial pre-operative weight was and the lowest weight they obtained post operatively. This is followed up by asking the patient if they experienced any post operative complications, if they still feel the effects of their surgery, if they ever had dumping syndrome, if they continue to have dumping syndrome now, and if they are currently experiencing symptoms of GERD. Often times, patients do not understand when asked if they feel the effect of their surgery and we have to go into further detail asking if they have any sense of restriction with eating, what types of foods they eat, and the quantity and quality of foods they are able to consume. We also often run across patients who do not know what dumping is or who were never educated post operatively on the type of diet they were expected to follow. It follows a common pattern that the further out patients are from initial surgery, the less likely they were to be educated on diet, exercise, side effects, and overall what was expected of them postoperatively. Another factor that is very common among patients seeking out revisional bariatric surgery is the lack of follow up that they had with their initial bariatric program. It would be safe to say that all of the patients we have seen seeking revision have had as little as a 2 year to as much as 25 year gap in follow up. The most prominent reason for seeking revisional bariatric surgery in the patients we have seen is weight regain, but one patient's regain is not always the same as another. In the initial evaluation appointment we have to evaluate further the factors behind the weight regain. We have seen patients come in with as little as a 20 pound weight regain or patients who have regained past their preoperative weight (>100 lbs.). Another variable is the amount of time in which patients gained the weight. This can vary from less than 6 months to over 10 years. Much of the time we find that the patient‟s weight regain has resulted from behavioral factors, but even these can be variable. Some patients developed reactive hypoglycemia that was never diagnosed and are driven to eat whatever is available due to alarmingly low blood sugars. Maladaptive eating is a commonly seen issue among our patient population. Some patients have issues with strictures, marginal ulcers, or chronic nausea and vomiting leading them to eat foods that will easily pass through their pouch and gastrojejunostomy. However, more often than not, many patients are uncomfortable with the feeling of restriction from their initial surgery and try to eat foods that will bypass this restrictive sensation. We have met many patients who honestly believe something is wrong with their surgery because they have an uncomfortable feeling in their chest when they eat certain foods Revisional Bariatric Surgery for Weight Regain 5 such as meat, bread, or pasta. We often have to remind the patient of the sensation of fullness they experienced in the immediate post-operative period and relate that to what they are feeling now. Many realize that it is the exact same feeling and that they have been trying to avoid that feeling by eating "slider foods" and foods that will bypass the restrictive nature of their surgery. ANATOMIC EVALUATION At their initial evaluation appointment, patients are scheduled for three specific tests which are usually performed within the following 2-3 weeks. These consist of an endoscopic evaluation of the gastric anatomy, barium upper GI, and nutritional laboratory evaluation. If nutritional intake concerns were noted in the patient interview, nutritional evaluation with the dietician is required. For those patients with laparoscopic adjustable bands, an upper GI, to evaluate for band slippage, hiatal hernia, or esophageal dilation, and nutritional lab work is performed. Occasionally endoscopy is used to evaluate for band erosion, but that is often not necessary [3]. The endoscopy is performed by the bariatric surgeon to evaluate the patient‟s gastric anatomy. Precise measurement of the various key anatomic aspects of bariatric anatomy has been a challenge as we do not have adequate measuring tools such as stick/ruler that can be inserted and used to make measurements during the procedure. One such instrument was previously sold commercially but is no longer available. Currently, measurements are specifically taken during the endoscopy as to the distance from the patient‟s incisors to the level of the z-line and to the level of the gastrojejunostomy in order to estimate gastric pouch length. We attempt to determine if the pouch is long and narrow (cylindrical) or wide (spherical) in order to make approximate volume calculations. With narrow pouches we estimate pouch width to be the same as gastrojejunostomy diameter and estimate volume in cm3 according to the formula for the volume of a cylinder, i.e., r2l. We estimate the diameter of the gastrojejunostomy, typically be retroflexing the scope in the Roux limb and photographing the scope passing across the anatomosis. The scope diameter is used as an internal standard to allow us to estimate the anastomotic diameter, e.g., 2-fold, 3-fold, 4-fold, etc. versus scope diameter (10mm). The surgeon also evaluates the pouch for evidence of hiatal hernia, ulcers, or a gastrogastric fistula, and for potential afferent limb elongation. A barium upper GI with air contrast is ordered with the additional request of ingestion of a barium tablet and barium meal ingestion at the end of the 6 Eric J. DeMaria and Meredith A. Grzybowski study. Patients are told to bring 6-8 ounces of cottage cheese with them to the study for preparation of the barium meal. A standard barium upper GI is performed followed by an evaluation using powdered barium mixed with the cottage cheese at a 1:1 concentration that the patient is asked to ingest until feeling full. While patients are often able to ingest between 4 and 6 ounces, sometimes up to 12 total ounces of the barium cottage cheese mixture are actually consumed. A final abdominal x-ray is performed to capture the volume and possible dilation of the pouch with the barium meal. We have tried chunky applesauce as an alternative for those patient that are unable to tolerate cottage cheese due to allergy, lactose intolerance, or refusal due to taste/texture, but the applesauce barium mixture appears to move too quickly through the pouch into the efferent limb before volume estimation can be obtained. There have also been several patients whose gastrojejunostomy was dilated to an extent that the barium cottage cheese mixture emptied too rapidly into the efferent limb and pouch volume estimation was inaccurate. Overall, this test has been beneficial in providing information on GERD, presence of hiatal hernia, ulcer, possible esophageal dysmotility issues, gastric pouch enlargement and volume, gastrojejunostomy enlargement, and possible afferent limb syndrome due to elongation of the blind end of the Roux limb (candy cane) seen with side to side gastrojejunostomy anastomosis. SURGICAL STRATEGIES Patients are brought back into the office after the testing is completed to review their results and determine what options are available to them. If their anatomy is intact, then we refer them for nutritional counseling with our dietician to get back on track with healthy eating habits and continue to follow them on a regular basis for bariatric follow up [1-4]. Patients are treated on an individual basis and plans are made with each patient depending on what was found during testing. Many patients are found to have a sliding hiatal hernia, a dilated gastric pouch, or a dilated gastrojejunostomy and frequently some combination of the 3 is found. At times, additional testing is necessary to determine a course of action for the patient. If significant GERD symptoms are found, esophageal manometry testing may confirm that the lower esophageal sphincter is hypotensive. In that case hiatal hernia repair and modified Dor, Toupet, or Nissen fundoplication may be performed with the degree of fundoplication decided during surgery depending on the technical issues found. Hiatal repair with fundoplication has Revisional Bariatric Surgery for Weight Regain 7 also proved to be a valuable intervention in American patients whose individual health insurance does not cover any further bariatric treatments as the diagnosis being treated by this intervention is gastroesophageal reflux disease. Patients presenting combination of a dilated gastric pouch and dilated gastrojejunostomy usually continue with the evaluation process for the potential of complete revision of their gastric bypass versus laparoscopic adjustable band placement over their existing bypass. Those patients with dilated gastrojejunostomy alone are considered for revision versus endoscopic plication of the gastrojejunostomy. In laparoscopic band patients suffering significant symptoms of excessive restriction with reflux and typical findings on upper GI the band is often completely deflated in the office. Mostly these patients choose to continue with evaluation for conversion to sleeve gastrectomy or roux-en-y gastric bypass. BEHAVIOR MODIFICATION As most patients have regained some amount of weight, whether it be due to maladaptive eating, hypoglycemia, or old habits returning, we require all patients to go through a nutritional evaluation with our dietician. Even if the patient‟s insurance company does not require a weight loss trial, we will often require patients to complete a minimum of 3 months in a weight loss class to relearn healthy eating habits and behaviors. We have come to require that a patient desiring surgical intervention for weight regain in the absence of a surgical complication must demonstrate a 10% total body weight loss during this time to confirm compliance and behavior change. Healthy eating habits and behaviors are essential for a successful revisional bariatric surgery, and patients are informed that their compliance with diet and exercise is essential in order to achieve positive results. SUMMARY Overall weight loss is less with revisional bariatric surgery and requires more effort on the patient‟s behalf. Patient selection for bariatric revisional surgery is key for both patient and programmatic success. With a multidisciplinary team and good communication between the patient and that team, success is possible. 8 Eric J. DeMaria and Meredith A. Grzybowski REFERENCES [1] [2] [3] [4] Brethauer SA, Kothari S, Sudan R, Williams B, English WJ, Brengman M, Kurian M et al. Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force. Surg. Obes. Relat. Dis. 2014;10:952-72. Johnson WH, Fernanadez AZ, Farrell TM, Macdonald KG, Grant JP, McMahon RL, Pryor AD, Wolfe LG, DeMaria EJ. Surgical revision of loop ("mini") gastric bypass procedure: multicenter review of complications and conversions to Roux-en-Y gastric bypass. Surg. Obes. Relat. Dis. 2007;3:37-41. Kellogg TA. Revisional bariatric surgery. Surg. Clin. North Am. 2011;91:1353-71. Zundel N, Hernandez JD. Revisional surgery after restrictive procedures for morbid obesity. Surg. Laparosc. Endosc. Percutan. Tech. 2010;20:338-43. In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 2 METABOLIC FAILURES AND BARIATRIC PROCEDURES Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen Center for Obesity and Diabetes, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil ABSTRACT There is an increasing body of evidence that bariatric surgery leads to higher remission rates of type 2 diabetes mellitus (T2DM) than any other medical treatment or lifestyle intervention. Several trials published so far comparing the effect of bariatric surgery and best medical treatment on diabetic obese patients have shown that T2DM reached up to 75-80% at the end of the study in the surgical group, although most studies have shown a relatively short period of follow-up. There is no doubt that bariatric procedures, primarily Roux-en-Y gastric bypass, are more effective at inducing T2DM remission. However, there is a lack of information regarding long-term results for disease control. In this chapter, the authors present long-term results of bariatric surgery over metabolic diseases remission. Email: [email protected]. 10 Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen INTRODUCTION During the past decades, the number of individuals with type 2 diabetes (T2DM) in the United States (U.S.) has more than doubled, showing that we are in the midst of an epidemic. Approximately 25.8 million Americans were diagnosed with diabetes (nearly 8.3% of the population), and by 2050 as many as one in three U.S. adults could have diabetes [1-2]. Furthermore, T2DM is the leading cause of kidney failure, non-traumatic lower-limb amputations, coronary heart disease, stroke, and visual impairments among adults in the U.S. [3]. Aside from high morbidity and premature mortality, T2DM imposes a substantial burden on the economy because of its significant medical costs and indirect costs that are the result of work absenteeism, reduced productivity and unemployment from chronic disability. In 2012, the American Diabetes Association (ADA) estimated that the total national cost of diabetes in the U.S. was $245 billion, of which more than 70% represented direct health expenditures [1]. This represents a 41% increase when compared to a previous estimate published in 2008 [4]. In addition, there has been a significant increase in health resources usage by people with diabetes. For example, diabetics incur approximately 25% of all U.S. hospital inpatient days, almost one third of all nursing/residential facilities days, and around half of all physician office, emergency department, and hospital outpatient visits. An even worse scenario is reported when analyzing data for a specific age, in particular the elderly [1]. For these reasons, it is estimated that health expenditures for diabetics are 2.3 times higher than they would be in the absence of T2DM. Prospective longitudinal studies have shown that bariatric surgery is the most effective intervention for obesity and its associated diseases, in particular T2DM, reducing the long-term mortality rate of morbidly obese patients when compared to clinical treatment [5-6]. The improvement of metabolic control in bariatric patients was observed as early as days or weeks after surgical procedure, long before considerable weight loss occurred, indicating a direct anti-diabetic effect of the procedure. Consequently, some operations began to be considered as an option to treat less obese patients with uncontrolled T2DM [7]. As expected, good results regarding metabolic control were obtained in this patient group without significant weight loss, particularly after Roux-en-Y gastric bypass (RYGB) [8-9]. Treatment goals are outlined in Table 1. Nonetheless, only limited information is available regarding long-term effects, recurrence or worsening Metabolic Failures and Bariatric Procedures 11 of metabolic diseases years after surgery, and factors associated with their reemergence. Table 1. Treatment goals for T2DM patients Partial remission Complete remission At least 1 year‟s duration At least 1 year‟s duration No active pharmacologic therapy or No active pharmacologic therapy or ongoing ongoing procedures procedures HbA1c < 6.5% HbA1c 4.5 – 6% FPG 100 – 125 mg/dL FPG < 100 mg/dL Secondary goals include: LDL < 100 mg/dL and blood pressure < 130x80 mmHg *HbA1c – glycated hemoglobin. FPG – fasting plasma glucose. LDL – low-density lipoprotein. EFFECTS IN TERMS OF GLYCEMIC CONTROL We recently published the largest and longest-term study to date to examine the safety and efficacy of RYGB in T2DM patients with BMI between 30 and 35 kg/m2. All patients were followed from 1 to 6 years (median 5 years). Main outcomes were safety and T2DM remission, defined as glycated hemoglobin (HbA1c) < 6.5% without medication. All patients had uncontrolled T2DM, despite appropriate lifestyle modifications and use of antidiabetic medications including or not insulin for at least 1 year. Mean preop HbA1c was 9.7% and mean duration of disease was 12.5 years. T2DM remission was observed in 88% of patients, with a significant reduction of HbA1c (9.7 to 5.9%), despite diabetes medication cessation in the majority of cases. Improvement of diabetes (HbA1c < 7% with lower doses of oral diabetes medications and no insulin) was achieved in 11% of patients. Only one patient in the entire cohort had no changes in diabetes evolution. All patients experienced significant weight loss at 5 years, however there was no correlation between the amount of weight loss and levels of fasting plasma glucose or HbA1c for the first 5 years. Beta cell function significantly improved as measured by C-peptide response to glucose load. No mortality, major surgical complication or massive weight loss were reported [9]. 12 Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen At 8 years follow-up, 11 (16.5%) patients with previous T2DM remission were back on antidiabetic drugs, 10 were using metformin alone and 1 patient was using a combination of vildagliptin and metformin. There was no correlation between T2DM recurrence and weight regain. Excess weight loss at 8 years was 69% for this series. During hospital admission and after discharge, all patients had their T2DM managed according to the following protocols adopted by our institution (Tables 2, 3 and 4). Table 2. Management of T2DM in the perioperative care (NPO status) BLOOD GLUCOSE (mg/dL) FROM 0 BLOOD GLUCOSE (mg/dL) TO 69 INSULIN (UI) IV GLUCOSE (g) ACTION 10 IV glucose G50% 20mL 70 99 0 Capillary blood glucose: 6am, 12pm, 6pm and 12am Long-acting insulin once a day Fast-acting insulin 100 149 0 Fast-acting insulin 150 199 1 Fast-acting insulin 200 249 3 Fast-acting insulin 250 299 5 Fast-acting insulin 300 349 7 Fast-acting insulin 8 Fast-acting insulin 180 350 9 A retrospective analysis by Di Giorgi et al. reporting on 42 post RYGB diabetic patients with a medium follow-up of 3 years showed resolution of diabetes in 64% at 6 months, while all patients had their diabetes improved. Pre-operative data showed that mean BMI was 51.4 kg/m2 and 34% of the participants were using insulin. At 3 years diabetes recurrence was experienced by 26% of patients with initial resolution and by 20% of patients with initial improvement. This group had lower preoperative BMI compared to those who did not recur. Such findings were not observed in our series, where correlation to weight regain was not observed [10]. Metabolic Failures and Bariatric Procedures 13 Table 3. In-hospital management of T2DM in postoperative care (patients on liquid diet) 1. Metformin 2 g per day (optimized) 2. DPP4 inhibitors BLOOD GLUCOSE (mg/dL) FROM 0 BLOOD GLUCOSE (mg/dL) TO 69 INSULIN (UI) IV GLUCOSE (g) IV glucose G50% 20mL Capillary blood glucose before breakfast, lunch, dinner and before 10 pm 180 * Long-acting insulin once a day (bed-time) 70 99 5 Fast-acting insulin before breakfast, lunch and dinner 100 149 6 Fast-acting insulin before breakfast, lunch and dinner 150 199 7 Fast-acting insulin before breakfast, lunch and dinner 200 249 9 Fast-acting insulin before breakfast, lunch and dinner 250 299 11 Fast-acting insulin before breakfast, lunch and dinner 300 349 13 Fast-acting insulin before breakfast, lunch and dinner 350 14 Fast-acting insulin before breakfast, lunch and dinner (*) If patient is under insulin treatment prior to surgery, reintroduce 50-70% usual dose of insulin and titrate according to fasting capillary blood glucose (target < 120 mg/dL) and postprandial capillary blood glucose (target < 180 mg/dL) * DPP4 - dipeptidyl peptidase 4. 10 ACTION 14 Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen Table 4. Outpatient T2DM management (long-term follow-up) 1. Metformin 2 g per day (optimized) 2. DPP4 inhibitors 3. Insulin If patient is under insulin treatment prior to surgery, maintain same dose used at hospital discharge and titrate according to fasting capillary blood glucose (target < 120 mg/dl) and postprandial capillary blood glucose (target < 180 mg/dl). Clinical practice shows that it usually takes 21 days to withdraw insulin therapy in patients with preserved beta cell function. * DPP4 - dipeptidyl peptidase 4. Chikunguwo et al. retrospectively studied 177 patients with T2DM who had undergone RYGB. Patients were followed-up from 5 to 16 years (mean 8.6 years). Complete T2DM remission was observed in 88.7% patients, but 43.3% recurred. In this study, T2DM recurrence was correlated with weight regain. The authors found that percentage of weight loss, gender, age and severity of T2DM were independent predictors of recurrence. Strongest predictors were insulin therapy and gender [11]. EFFECTS IN TERMS OF LIPIDS CONTROL AND CARDIOVASCULAR OUTCOMES Metabolic surgery benefits that go beyond glucose control include a positive effect on lipid profile. Increases in high-density lipoprotein (HDL) cholesterol have already been reported one year after RYGB [12, 13], however data are still limited to non-controlled studies in morbidly obese patients. Although the actual role played by HDL in the reduction of cardiovascular risk is still unclear [14], there is some evidence that increase in HDL is associated with a reduced progression of atherosclerosis and hence better cardiovascular outcomes, which constitutes a major benefit from metabolic surgery [15, 16]. We examined other cardiovascular risk factors in diabetic patients with low BMI submitted to RYGB and found that hypertension resolved in 58%, hypercholesterolemia in 64%, and hypertriglyceridemia in 58%. For the entire cohort, mean blood pressure progressively decreased over the course of six years [9]. There was also a significant improvement over the six years in lipid parameters, with progressive reductions in total cholesterol, LDL cholesterol Metabolic Failures and Bariatric Procedures 15 and triglycerides, and increase in HDL cholesterol. These changes led to a 10year decrease in fatal and non-fatal stroke and myocardial infarction numbers. Other studies have shown beneficial effects of gastric bypass on diabetes and reduced mortality from heart disease in morbidly obese subjects [16, 17]. A recent report from the Swedish Obese Subjects (SOS) study [18] demonstrated the reduction of myocardial infarction incidence in obese diabetic patients following bariatric surgery. We reported the favorable outcomes of metabolic surgery in low BMI patients that go beyond glycemic control, as indicated by the substantial reductions in hypertension and dyslipidemia, yielding major improvements in predicted CV risk. Our results are similar to small, observational studies from India, China and South America [19, 20, 21], although follow-up in these studies was relatively short. WHAT IS THE ROLE OF WEIGHT LOSS IN THE INCIDENCE OF CARDIOVASCULAR EVENTS? Lifestyle interventions to prevent T2DM have not avoided cardiovascular events, including in long-term follow up [22, 23]. Sjostrom et al. [15], in the Swedish Obese Subjects study, a non-randomized prospective study, concluded that, compared to usual care, bariatric surgery leads to a reduced number of cardiovascular events and deaths. One of the most important findings in the Swedish study was the lack of correlation between BMI and cardiovascular mortality and/or events. And, conversely, a positive correlation with fasting plasma insulin levels. The Look AHEAD study [24] showed that intensive lifestyle modification may induce significant improvements in intermediate health indicators, such as body weight, fitness, blood pressure, glycemic control, and lipids. These improved risk factor profiles, however, did not translate into lower rates of non-fatal myocardial infarction, non-fatal stroke, hospitalization for angina, or death compared with conventional diabetes treatment [25]. Look AHEAD found that people who are obese and suffer from T2DM can lose weight and maintain weight loss with a lifestyle intervention. Although the study found that weight loss had many positive health benefits for patients with T2DM, it did not reduce the number of cardiovascular events. Evidence is increasing that metabolic surgery is more effective than medical or lifestyle interventions for weight loss and diabetes remission. In a recent analysis by Arterburn et al. [26] of severely obese patients with diabetes, the adjusted probability of initial remission was 12 to 16 Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen 24 times greater for the 1395 patients who had bariatric surgery than for the 62322 who received usual medical care alone. In a recent editorial, the same author [27] stated that the benefits of intensive lifestyle treatment for T2DM were more prominent in patients with early stage diabetes, similar to what was reported in bariatric surgery, showing better results in milder, earlier stage disease. Consequently, a strong argument can be made for considering earlier surgical intervention in moderately obese patients (BMI <30 kg/m2) with early stage diabetes, in particular in those with severe insulin resistance, higher cardiovascular risk and uncontrolled disease. This argument backs up the 2011 International Diabetes Federation (IDF) statement on new perspectives on surgical treatment of uncontrolled T2DM in patients with BMIs between 30 and 35 kg/m2 [28]. Timing of metabolic surgery is of the utmost importance for T2DM remission. In a retrospective study, Arterburn et al. [27] found that almost 35% of the patients who went into remission following RYGB redeveloped T2DM within five years of surgery. Predictor factors were poor preoperative glycemic control, insulin use and longer diabetes duration, indicating that the earlier the intervention takes place the better [26]. From the above, one may conclude that the Look AHEAD study fundamentally shows that weight loss does not appear to reduce T2DM-associated cardiovascular disease, but rather enhances the benefit of interventions aimed at improving diabetes (diet, surgery etc.). IS THERE A SURGICAL TREATMENT OPTION FOR PATIENTS WITH TYPE 2 DIABETES RECURRENCE? Over recent years, the aim of metabolic/bariatric surgery has changed from weight loss only to metabolic control. So far, there is no recognized definition of what constitutes failure of metabolic surgery, much less an accepted standard of care for patients who fall into this category. Table 5. Definitions for T2DM recurrence Partial recurrence HbA1c 6.5-7%, but higher than lowest level reported after surgery Addition of 1 oral antidiabetic agent *HbA1c – glycated hemoglobin. Complete recurrence HbA1c > 7% and higher than lowest level reported after surgery Addition of 2 or more oral antidiabetic agents and/or insulin Metabolic Failures and Bariatric Procedures Figure 1. T2DM recurrence after laparoscopic adjustable gastric band (LAGB). Figure 2. T2DM recurrence after sleeve gastrectomy. 17 18 Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen Arterburn et al. proposed the following criteria for T2DM relapse after bariatric/metabolic surgery. One or more of the following conditions should be fulfilled: (a) restarting diabetes medication; (b) one or more HbA1c readings ≥ 6.5%; and/or (c) one or more fasting glucose values ≥ 126 mg/dl [26]. Interestingly, the authors examined the T2DM relapse rate only among subjects who initially experienced a diabetes remission after surgery (partial or complete). In this chapter, we propose new criteria for patients who do not fall into the remission category but who had their metabolic conditions improved after surgery and, for unknown reasons, later experienced worsening of their metabolic status. These patients should be considered as suffering from T2DM recurrence (and not relapse), and may be divided into two categories (Table 5). Patients with T2DM recurrence may be candidates for revisional surgery after optimized clinical treatment (Figures 1, 2, 3). Figure 3. T2DM recurrence after gastric bypass. Metabolic Failures and Bariatric Procedures 19 CONCLUSION When offering surgical treatment aiming at durable diabetes remission, patient selection and counseling are of the utmost importance. We found that patients with a longer history of diabetes and those under insulin treatment were more likely to relapse than those who were not using insulin or who had diabetes for less than 10 years. However, not all patients receiving insulin failed to achieve diabetes remission. An earlier surgical intervention clearly appears to be preferable. However, more severely affected and insulindependent diabetic patients may benefit from surgery as well, since these patients, although unable to interrupt diabetic medication, may experience improvement in retinopathy, nephropathy, and other diabetes-related conditions. Furthermore, these patients may benefit from a significant improvement in quality of life and experience remission of other metabolic diseases. It is also believed that an aggressive glycemic control may induce beneficial “metabolic memory” – be it transiently – as reported in the UKPDS study, and reduce the incidence of microvascular complications [29]. Therefore, patients with T2DM recurrence after metabolic surgery may still continue to experience reduced microvascular and macrovascular complications in the long-term when compared to those who never had their disease controlled. REFERENCES [1] [2] [3] [4] American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care 2013, 36:1033-46. Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul. Health Metr 2010, 8: 29. Lebovitz HE. Science, clinical outcomes and the popularization of diabetes surgery. Current Opinion in Endocrinology, Diabetes and Obesity 2012, 19: 359–66. American Diabetes Association. Economic costs of diabetes in the U.S. in 2007. Diabetes Care 2008; 31: 596–615. 20 [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] Pedro Paulo Caravatto, Tarissa Zanata Petry and Ricardo Cohen Sjöström L, Lindroos A-K, Peltonen M et al. Lifestyle, diabetes and cardiovascular risk factors 10 years after bariatric surgery. New Engl. J. Med. 2004, 351: 2683-93. Sjöström L, Narbro K, Sjöström CD et al. Effects of bariatric surgery on mortality in Swedish obese subjects. New Engl. J. Med. 2007, 357: 74152. Rubino F. Is type 2 diabetes an operable intestinal disease? A provocative yet reasonable hypothesis. Diabetes Care 2008, 31: S290-6. Schauer PR, Burguera B, Ikramuddin S et al. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann. of Surg. 2003, 238: 467–84. Cohen RV, Pinheiro JC, Schiavon CA et al. Effects of gastric bypass surgery in patients with type 2 diabetes and only mild obesity. Diabetes Care 2012, 35: 1420–8. DiGiorgi M, Rosen D J, Choi J J, et al. Re-emergence of diabetes after gastric bypass in patients with mid- to long-term follow-up. Surg. Obes Relat. Dis. 2010; 6: 249-53. Chikunguwo S M, Wolfe L G, Dodson P, et al. Analysis of factors associated with durable remission of diabetes after Roux-en-Y gastric bypass. Surg. Obes. Relat. Dis. 2010; 6: 254-9. Kim S, Richards WO. Long-term follow-up of the metabolic profiles in obese patients with type 2 diabetes mellitus after Roux-en-Y gastric bypass. Ann. Surg. 2010; 251: 1049-55. Asztalos BF, Swarbrick MM, Schaefer EJ, et al. Effects of weight loss, induced by gastric bypass surgery, on HDL remodeling in obese women. J. Lipid Res. 2010; 51: 2405-12. Voight BF, Peloso GM, Orho-Melander M, et al. Plasma HDL cholesterol and risk of myocardial infarction: a Mendelian randomisation study. Lancet 2012; 380: 572-80. Sjöström L, Peltonen M, Jacobson P, et al. Bariatric surgery and longterm cardiovascular events. JAMA 2012; 307: 56–65. Adams TD, Gress RE, Smith SC et al. Long-term mortality after gastric bypass surgery. N. Engl. J. Med. 2007; 357: 753-61. Carlsson LM; Peltonen M, Ahlin S et al. Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects. N. Engl. J. Med. 2012; 367: 695-704. Romeo S, Maglio C, Burza MA, et al. Cardiovascular events after bariatric surgery in obese subjects with type 2 diabetes. Diabetes Care 2012; 35: 2613-7. Metabolic Failures and Bariatric Procedures 21 [19] Shah SS, Todkar JS, Shah PS, et al. Diabetes remission and reduced cardiovascular risk after gastric bypass in Asian Indians with body mass index <35 kg/m2. Surg. Obes. Relat. Dis. 2010; 6: 332–8. [20] Cohen R, Caravatto PP, Correa JL, et al. Glycemic control after stomach-sparing duodenal-jejunal bypass surgery in diabetic patients with low body mass index. Surg. Obes. Relat. Dis. 2012; 8: 375–80. [21] Schauer PR, Kashyap SR, Wolski K et al. Bariatric surgery vs. intensive medical therapy in obese patients with diabetes. New Engl. J. Med. 2012, 366: 1567-76. [22] Yamaoka K, Tango T. Efficacy of lifestyle education to prevent type 2 diabetes: a meta-analysis of randomized controlled trials. Diabetes Care 2005; 28: 2780–6. [23] Li Q, Chen L, Yang Z, et al. Metabolic effects of bariatric surgery in type 2 diabetic patients with body mass index <35 kg/m2. Diabetes Obes Metab. 2011; 14: 262–70. [24] Look AHEAD Research Group, Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch. Intern. Med. 2010, 170: 1566– 75. [25] Gregg EW, Chen H, Wagenknecht LE et al. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA 2012; 308: 2489–96. [26] Arterburn D, Bogart A, Coleman KJ et al. Comparative effectiveness of bariatric surgery vs. nonsurgical treatment of type 2 diabetes among severely obese adults. Obes Res Clin Pract 2013, 7: e258-68. [27] Arterburn DE, O‟Connnor PJ. A look ahead at the future of diabetes prevention and treatment. JAMA 2012, 308: 2517-9. [28] Dixon JB, Zimmet P, Alberti KG, Rubino F. Bariatric surgery: an IDF statement for obese Type 2 diabetes. Diabet. Med. 2011, 28: 628-42. [29] Murray P, Chune GW, Raghavan VA. Legacy effects from DCCT and UKPDS: what they mean and implications for future diabetes trials. Curr. Atheroscler Rep. 2010; 12:432–9. In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 3 DIAGNOSTIC TOOLS IN FAILED BARIATRIC PROCEDURES Rudolf Weiner1,*, MD, PhD, Islam A. El-Sayes1,†, MD, and Sylvia Weiner2,‡, MD 1 Center for Surgery for Obesity and Metabolic Disorders (Center of Excellence) Sana Klinikum Offenbach, Offenbach am Main, Germany 2 General Surgery Department, Faculty of Medicine, Alexandria University, Egypt ABSTRACT Worldwide, there is an evident increase in the incidence and accordingly in the prevalence of obesity. Current estimates postulate that the incidence of obesity will reach about 40% of the adult population by the year 2030. Importantly, developing countries do not seem to be immune against this epidemic. Accordingly, the worldwide performance * Corrsponding author: Rudolf Weiner (Weiner R), MD, PhD. Center for Surgery for Obesity and Metabolic Diseases (Center of Excellence). Universitary Hospital Sana Klinikum Offenbach.Clinic for Obesity and Metabolic Surgery. Starkenburgring 66. Offenbach am Main. Germany. [email protected]. † [email protected]. ‡ [email protected]. 24 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner of bariatric procedures is showing a corresponding yearly increase. Recent procedures such as sleeve gastrectomy are currently replacing old standard techniques. The increase in bariatric surgery numbers is unfortunately associated with complications that cannot be under estimated and that have been reported with all procedures. That is why timely diagnosis and management of these complications is an integral part of bariatric practice. Complications or (failures) can be broadly divided in early and late complications. Although readily reported, failure does not have a standardized definition. Gastric band has a special foreign body-associated nature and will therefore be separately discussed. Acute failures or complications can be detected through reliable clinical symptoms and signs summarized in this chapter. Radiological studies and diagnostic laparoscopy are essential diagnostic and therapeutic tools. Late complications or failures will be thoroughly discussed. Standardized techniques play the main role in the diagnosis of failure after bariatric intervention. These techniques can be implemented in all procedures. All these techniques will be discussed with their possible pros and cons. Diagnostic techniques include: radiological studies, endoscopy and diagnostic laparoscopy. Radiological studies include for example contrast-enhanced upper GI series, computed tomography and three-dimensional tomographic reconstructions. The role of endoscopy and diagnostic laparoscopy will also be highlighted. INTRODUCTION In 2005, 23.2% (937 million) of the world‟s adult population was overweight, and 9.8% (396 million) was obese. According to current projections, from 2005 to 2030 the number of overweight individuals will increase by 44%, to reach a total of 2.16 billion, corresponding to 38% of the world‟s adult population [1]. During the same interval, the number of obese individuals will increase by 45% to reach a total of 1.12 billion (20% of the world‟s adult population). In 2005, the prevalence of overweight was higher in economically developed countries compared to developing countries (35.2 vs 19.6%). Similarly, the prevalence of obesity was higher in developed countries compared to developing ones (20.3 vs 6.7%). However, growth in population size, aging, and urbanization of lifestyle will all contribute to an epidemic of overweight and obesity in developing regions in the next few decades [1]. This overwhelming increase in the prevalence of morbid obesity with its associated comorbidities pushed institutions worldwide to search for new minimally invasive modalities to face this epidemic. Over the past years, standard Diagnostic Tools in Failed Bariatric Procedures 25 procedures like biliopancreatic diversion (BPD), duodenal switch (DS), gastric banding (LAGB), and Roux-en-Y gastric bypass (RYGB) established their position in the armamentarium of bariatric procedures. Other procedures such as sleeve gastrectomy and mini-gastric bypass are also partially replacing old standard procedures. More recently, newer surgical as well as endoscopic bariatric procedures started to compete with these standard procedures. However, this increasing number of performed bariatric interventions does not come without complications, either acute early complications or late complications (failures) [2]. Unsatisfactory gastrointestinal manifestations were reported in 16.9% of patients who underwent RYGB, 7.8% of LAGB and 37.7% of BPD patients [2]. Reflux was reported by 10.9% of RYGB, and 4.7% of LASGB patients. Stomal stenosis was present in 4.6% of RYBG patients. Even sleeve gastrectomy, although one of the most recent procedures, suffers failures and complications as reported in many reviews [3, 4]. These complications attributed to bariatric interventions may be indications for operative revisions. In addition to these (anatomical) failures, another very important cause of failure indicating revision is weight gain after bariatric intervention. Some reports postulated that the most common cause for revision after a bariatric intervention is weight regain or insufficient primary weight loss after the intervention [5, 6]. Gagner reported that weight regain was the main cause of re-operation in about 90% of patients in his series [6]. The consideration of an intervention as failing needs an adequate definition and a standardized diagnostic approach in order to correctly diagnose and then treat a failure when it occurs. DEFINITION OF A FAILED BARIATRIC PROCEDURE Controversy exists regarding the definition of a failed bariatric procedure. The wide spectrum of bariatric procedures performed worldwide and the lack of standardized criteria to define success or satisfactory outcome following a procedure plays a role. Another factor is the variation in the expected weight loss results following each procedure. Baltasar in a recent meta-analysis proposed that sleeve gastrectomy achieves the greatest mean BMI reduction (12-17 units) while gastric banding produces the least satisfactory outcome in terms of weight loss [7]. Another factor leading to the lack of definition of failure is the indication for revision after a (possibly) failed procedure. Failure or revision after most procedures is mainly due to inadequate weight loss. In the specific field of 26 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner LAGB migration or slippage are important indications contributing to the consideration of gastric band as a (failed) procedure. This issue has been addressed in a recent systematic review by Mann and his colleagues [8]. Although Body Mass Index Loss is the most accurate interpretation tool for a successful or a failed procedure, still other indices are being used by other authors, for example percentage of total body weight, or change in BMI [8, 9]. The most frequent cited definition for failure after bariatric surgery as reported by Mann et al. was: <50% of excess weight lost (EWL), with or without residual BMI of greater than 35 kg/m2, at 18 months post-operation. The second most frequently cited definition was: <25% of excess weight lost (without a time-frame specified). However, in all the reviewed studies, there was surprisingly no comment on the effect of the primary procedure on the associated metabolic status of the patient. Consequently, remission or persistence of the associated primary metabolic impairment (diabetes and hypertension in the first place) was not listed as factor in assessing whether this procedure was successful or failed. Additionally, most of the reviewed studies failed to report the selection criteria for failure. In our opinion, factors such as patient dissatisfaction with the procedure, food intolerance, and impairment of a healthy life style should also be part of the consideration of the procedure as a failed procedure. In summary, a consensus for standardization of the definition of failure after bariatric procedure is still lacking. SPECTRUM OF FAILURE OF A BARIATRIC PROCEDURE A pitfall in most currently implemented definitions for a failed procedure is, in our opinion, the concentration on a long-term failure, and ignoring the acute or short-term failure. A failed procedure is also a procedure which can, in the early post-operative course, be associated with complications. Accordingly, early leakage or bleeding should also be counted as acute failures and should be timely and thoroughly diagnosed and accordingly managed. Hence, we would like to classify failures broadly as: acute failures (can also be referred to as: acute complications) and long-term failures. Diagnostic Tools in Failed Bariatric Procedures 27 ACUTE FAILURE, DIAGNOSIS AND POSTULATED ALGORITHM (FOR ALL PROCEDURES OTHER THAN GASTRIC BANDING) To be considered successful a bariatric intervention requires thorough understanding of the associated anatomical and physiological changes. Consequently it is preferably performed by a highly experienced team, that can diagnose and timely manage any deviation from the normal postoperative course. Otherwise, potentially devastating outcomes may occur. Recent data from the USA have reported postoperative complication rates ranging between 2.2-10.8 percent [10-12]. Retrospective analysis of our unit‟s data revealed an early postoperative morbidity rate of 7.1 percent [13]. Early postoperative failure includes, primarily, leakage and bleeding. In order to prevent and timely manage these events, a triad of adequate preoperative preparation, adoption of standardized operative technique and meticulous postoperative care is strongly recommended. During the early postoperative phase, persistent unexplained tachycardia of more than 100 beats/min, fever (≥38.5°C), abdominal pain, tachypnea (>20 breaths/min) or decreased urinary output despite good hydration must induce a high index of suspicion. Laboratory findings of C-reactive protein (CRP) >150 mg/L, leukocytosis >11,000 cells/ml or a drop in plasma hemoglobin of more than 2 gram/dl also suggest the development of complications. We recommend CRP level and complete blood count to be routinely checked on the first and fifth postoperative day. Diagnostic radiological and endoscopic tools should also be readily available but they are not routinely used in uncomplicated cases. In our center, all patients are discharged on the fifth postoperative day, as long as the postoperative course is smooth. Our experience suggests that postoperative hospital stay of up to five days ensures adequate perioperative patient assessment, unless postoperative complications necessitating a prolonged hospital stay are encountered. Accurate diagnosis and timely management of acute failure of a bariatric intervention can be highly challenging. Particular care must be given to this high-risk patient group, where results of laboratory parameters may be misleading. Reliable clinical evaluation and interpretation of radiological studies pose another challenge. Thus, diagnosis and management of postoperative complications require an integrated teamwork approach that analyzes the triad of clinical suspicion, altered laboratory profile and abnormal 28 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner radiological studies. More importantly, to date, we lack a consensus for sound management of those complications. HOW TO DIAGNOSE A POSSIBLE EARLY COMPLICATION? 1. Laboratory Parameters Routine postoperative check of patient‟s laboratory profile (full blood count and CRP) should be a standard practice. Any deviation from the normal values should be strictly monitored. CRP and leukocyte count play a major role in the early detection of postoperative complications, especially staple line disruption and leakage [14] Analysis of our data showed that elevated CRP and leukocytosis were detected in 18 patients (36.5 percent) out of 49 patients and 31 patients (47%) out of 66 patients with early complications after RYGB and sleeve gastrectomy respectively, including 19 patients (86.3%) and 12 patients (100 percent) who developed early postoperative leakage after those procedures [13]. Postoperative check of hemoglobin level is also mandatory. A drop of more than two grams/dl should warrant further work up, especially if combined with tachycardia, evidence of gastrointestinal bleeding or excessive bloody drain effluent. 2. Clinical Symptoms and Signs Abdominal pain, nausea and vomiting requiring excessive analgesic or antiemetic treatment should raise the suspicion of possible complications. Hypotension, tachycardia, fever, tachypnea, dyspnea, low urinary output and abnormal color or increased volume of drain effluent should also be handled with a high index of suspicion [15]. Additionally, hematemesis or melena raise the suspicion of staple line bleeding. To date, the sensitivity and specificity of these parameters have not been well studied. Tachycardia seems to be correlated with the highest sensitivity and specificity amongst the other parameters [16, 17]. In our center, tachycardia was found in five patients (42%) and seven patients (37%) who developed early post-operative leakage and bleeding respectively [13]. Diagnostic Tools in Failed Bariatric Procedures 29 3. Radiological Studies Extravasation of gastrointestinal contents can be diagnosed radiologically by contrast-enhanced computed tomography (CT) scans with oral contrast (Figure 1) or by gastrograffin swallow studies (Figure 2). Figure 1 and Figure 2. Extravasation of gastrointestinal contents can be diagnosed radiologically by contrast-enhanced computed tomography (CT) scans with oral contrast (Figure 1) or gastrografin swallow studies (Figure 2). 30 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner The presence of an abscess cavity, air foci (Figure 1) in the vicinity of the operative field or stranding in the mesentery on CT scans raise the possibility of leakage. Pleural effusion or pneumonia may also be suggestive of an underlying leak [18]. Intra- as well as extra-luminal bleeding can be diagnosed by CT scans. [19, 20]. The same applies to abdominal wall bleeding and intraoperatively inflicted solid organ injury. Some authors perform routine postoperative gastrograffin upper GI series for all their patients due to simplicity and relatively low cost of the procedure [21]. Negative studies should however not mislead the surgeon in the presence of a strong clinical suspicion [15]. Mittermair et al. [22] reported complete inadequacy of gastrograffin series to detect leakages in their patients. Such data together with the radiation exposure accompanying these diagnostic modalities questions the necessity of their routine postoperative use. 4. Diagnostic Laparoscopy (DL) DL is the most reliable tool to confirm or rule out serious early postoperative issues including leakage and extra-luminal bleeding in patients with suspicious clinical, laboratory or radiological findings. In our personal series, we have observed a 100% specificity for DL in 23 patients with complicated sleeve gastrectomy: DL confirmed complicated post-LSG course (13 patients with bleeding, nine with leakage and one with trocar-site hernia). This observation should be compared with the findings with RYGB: a specificity of only 70 percent in 33 patients with suspected complications. DL confirmed complications suspected by routine postoperative check in only 23 patients (12 patients with leakage, seven with bleeding, three with trocar site hernia, and one with small bowel obstruction) whereas it was negative in 10 patients (Table 1). The discrepancy between RYGB and sleeve gastrectomy may be attributed to the fact that DL can miss some complications such as transient internal herniation, twisted gastro-jejunal or entero-enteral anastomotic reconstruction, intussusception or anastomotic ulcer post-RYGB. These factors that can lead to transient deviation from normal post-RYGB course are not encountered after LSG. The results are currently under further analysis for future publication. The incidence of bleeding after obesity surgery ranges from 0.6 to 4 percent [23, 24]. Stapling through highly vascular tissues can be followed by considerable amount of intra- as well as extra-luminal (intra-peritoneal) 31 Diagnostic Tools in Failed Bariatric Procedures bleeding. Bleeding should be controlled by surgical intervention (hematoma evacuation, over-sewing, and drainage) when patients are hemodynamically unstable. In hemodynamically stable patients, we usually resort to conservative methods with fluid resuscitation, blood transfusion (if necessary) and careful observation. Table 1. Value of diagnostic laparoscopy (DL) in patients with a suspicious (*) post-operative course after LSG vs. LRYGB First detected indication for DL Elevated CRP LSG N = 23 Diagnosis confirmed by positive DL Leakage: 7 Negative DL LRYGB N = 33 Diagnosis confirmed by positive DL Negative DL 0 Leakage: 9 Trocar site hernia: 2 4 Tachycardia Bleeding: 9 Leakage: 1 0 Bleeding: 6 Leakage: 3 4 Abdominal pain Bleeding: 3 Trocar site hernia: 1 0 Bleeding: 1 Trocar site hernia: 1 2 Suspicious CT scan Bleeding: 1 0 SBO: 1 0 Leakage: 1 Total number (%) 23 (100%) (p<0.05) 0 (0%) 23 (70%) 10 (30%) LRYGB: laparoscopic Roux-en-Y gastric bypass, SBO: small bowel obstruction. Values refer to number of patients in whom DL was done and confirmed or excluded a suspected acute post-LSG complication. * Suspicious means: Persistent unexplained tachycardia of more than 100 beats/min, fever (≥38.5 C), a more than routinely-encountered post-operative abdominal pain, tachypnea (>20 breaths/min), or decreased urinary output despite good hydration, C-reactive protein (CRP) >150 mg/l, leukocytosis >11,000 cells/μl or a suspicious CT scan. We propose the following algorithm (Algorithm 1) for possible diagnosis and management of acute failures after bariatric intervention. 32 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner Algorithm 1. Management of patients with suspected acute leakage after bariatric intervention. LATE FAILURE AFTER BARIATRIC INTERVENTION; SPECTRUM OF DIAGNOSTIC MODALITIES After briefly discussing the acute failure of a bariatric procedure, we would like to address the long-term failure of a bariatric procedure, which is a failure occurring after an uneventful early post-operative phase. All bariatric procedures can be subjected to long-term failure. In our opinion LAGB should be separately discussed because of the specific nature of this foreign body-associated procedure. In addition to the common causes of long-term failures encountered with other procedures (weight regain, reflux, hiatal herniation, ulceration,…..) and urgent bandrelated conditions (gastric perforation, volvulus, abscess formation,….), Diagnostic Tools in Failed Bariatric Procedures 33 LAGB can cause two special conditions or causes of failure, namely: band slippage and band migration. Diagnosis of Band Slippage Band slippage is encountered in 4-13% of patients [25]. Patients with slipped band usually present with manifest upper abdominal pain and acute upper obstructive manifestation. If neglected these can progress to gastric gangrene by strangulation of the blood supply of the pouch. Band slippage is usually an acute condition, and should be timely diagnosed and properly managed. Band slippage is often recognized on gastrografin upper abdominal series. The slipped band tends to be more horizontally placed [26]. Through the weight of the herniated stomach, the anterior and posterior band margins are no longer opposed and give the so called O sign [27]. Because of the progressive obstruction and strangulation, an air-fluid level may appear in the proximal gastric pouch. Diagnosis of Band Erosion Band erosion is usually a gradual process that can progress from incomplete to complete intra luminal band migration. Band migration usually presents with vague manifestations, including loss of restriction (with possible weight gain), upper abdominal pain and port site pain or port site infection. Band erosion is typically detected by gastroscopy. A systematic review of band erosion in 15,775 patients revealed 231 cases of erosion (1.46%) in 15,775 all detected by gastroscopy [28]. This experience should not understate the role of radiological interventions in the diagnosis of this event. In fluoroscopic series, a leak of contrast around the eroding location of the band can be detected. CT scans can also detect a completely migrating band, with more certainty than incomplete erosion [29]. Port-Related Complications Two important port-related complications are port inversion and tubing defect or disconnection. Port displacement can be readily detected in abdominal radiographs. Tubing system defect or disconnection can be 34 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner diagnosed by water soluble contrast material injection in the port system. We propose an algorithm for rapid assessment and diagnosis of gastric band failures (algorithm 2) Algorithm 2. How to manage a failed band. RADIOLOGICAL DIAGNOSTIC TOOLS FOR A FAILED BARIATRIC INTERVENTION Fluoroscopy (Upper GI Series) Water-soluble contrast upper GI series have commonly been used to show the pathway constructed by a bariatric procedure, be it restrictive or Diagnostic Tools in Failed Bariatric Procedures 35 malabsorptive. In sleeve gastrectomy, the currently most commonly performed restrictive procedure, different patterns of the residual stomach have been described by Werquin et al. [30]: a tubular pattern (66%) with a uniform caliber, the superior pouch pattern (26%, with a wide superior component of the retained fundus that gradually fills), the inferior pouch pattern (8%, with a wide residual distal component), the superior-inferior pouch pattern (both proximal and distal pouches), the pseudodiverticular pattern with a diverticular dilatation of the lesser curve. Other rare patterns, such as the corkscrew have also been reported [31]. Long-term failure of sleeve gastrectomy can be seen in fluoroscopic upper GI series, where gastric dilatation or stenosis can be diagnosed. Gastric dilatation is usually suspected in fluoroscopy by loss of the normal tubular pattern of the sleeve and pouch enlargement. Stenosis can be readily seen by impaired distal contrast flow, and may be associated with proximal gastric dilatation (Figure 3), gastro-oesophageal reflux and hiatal herniation. Figure 3. Stenosis can be associated with proximal gastric dilatation. Upper GI series play also a significant role in failed malabsorptive procedures. Assessment of the proximal pouch, the alimentary limb and the site of the gastro-eneterostomy can be accomplished by fluoroscopic series. Gastric pouch size can be readily assessed by upper GI series, especially if 36 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner compared with immediate post-operative series. Shah et al. [32] described that the size of the gastric pouch after RYGB should be the same as that of lower thoracic or lumbar vertebral body. Upper GI series by their dynamic nature allow to demonstrate stenosis of the gastroenterostomy. Pouch distension and delayed passage of contrast through a smooth narrowing are highly suggestive for this condition [32]. Although not typically diagnosed in upper GI series, a stenosis of the entero-enteral (JJ) anastomosis can also be shown on these series. If stenosis is associated with significant stasis at the pancreaticobiliary limb, symptoms may include pancreatitis and biliary stasis. The stasis may be severe enough to induce gastrogastric fistulation or rupture (blow out) in acute cases. This situation may be diagnosed on dynamic series by stasis of contrast flow, retrograde passage in the biliopancreatic limb or reflux in the alimentary limb. Plain abdominal films may also show fluid level formation. In malabsorptive procedures a specific cause of failure is blind loop formation. This formed sac acts as a reservoir or a second stomach, which overtime may lead to loss of the restrictive element of the procedure. Late evacuation of its contents is in our opinion another cause for late dumping symptoms. Additionally, recurrent abdominal colics and bacterial overgrowth may be associated with blind loop sac formation. Marginal ulcers developing at the gastroenerostomy site are an important cause of failure after bariatric procedures, usually presenting with vague upper abdominal complaints (Pain, nausea, vomiting, etc). Smoking and chronic acid exposure are possible precipitating factors. In upper GI series these ulcers can be seen as ulcer niches at the anastomosis site or in the proximal part of the alimentary limb [33]. Another condition that may occur after bypass procedures is internal herniation, a situation linked tot the creation of peritoneal defects. This condition can also be detected in GI series when small bowel limbs containing contrast in their lumens are seen within the hernia space [34, 35]. Dynamic upper GI series may also help in the diagnosis of gastro-gastric fistulation, when contrast flows in the distal pouch. Despite the value of fluoroscopy in obesity practice, practical difficulty in performing the study may influence interpretation [36]. Practical difficulties include for example fluoroscopy table weight limit. Most currently used static tables tolerate not more than 550 pounds (400 pounds for movable tables). However, larger capacity systems are now available with weight limits up to 600 pounds for static tables and 500 pounds for movable tables. The problem of poor interpretation can be overcome by performing the study in supine Diagnostic Tools in Failed Bariatric Procedures 37 position with lateral spread of weight, leading to decreased thickness of abdominal wall tissues and accordingly better interpretation of the study with a lower dose of radiation. Another issue is the distance between the table and the radiation source, which typically ranges from 45 to 49 cm, and reaches in recent devices up to 60 cm. Performing the study in supine position may allow a better accommodation of the patient in the device. A third problem is the width of the table, which if insufficiently wide, may lead to patient instability during the examination. A fourth problem is the need for a higher dose of radiation to penetrate through a relatively thicker abdominal wall. In fluoroscopic diagnostic studies we prefer to use water soluble contrast (Gastrograffin). This avoids the risk of barium induced peritonitis and at the risk of impaction at any stenotic site. An important precaution point is to allow for a reasonable period of fasting after gastrografin intake in cases where an operation is indicated. Alternatively, gastric decompression should be tried. Several reports documented the irritating hypertonic effect of gastrografin on bronchial epithelium, and the occurrence of marked pulmonary oedema and even death in case of aspiration [37]. Apart from 3D gastric pouchography, which is of utmost importance in follow-up of all bariatric interventions, conventional abdominal CT scans (enhanced by oral and intravenous contrast) are also of value in assessing failure or complications after bariatric interventions. Because we are focusing in this chapter on long-term failures after bariatric interventions we will not discuss the major role of CT scans in assessing acute complications after surgical interventions. Instead, we will mention some possible causes of failure, that can be diagnosed on routine CT scans. Recurrent weight gain or insufficient weight loss can result from enlargement of the constructed pouch and/or the alimentary limb. This can be easily detected on abdominal CT scans. After sleeve gastrectomy, loss of the normal tubular shape of the constructed pouch denotes a possible cause of insufficient weight loss. After malabsorptive procedures, pouch enlargement, distension of the alimentary limb, or widening of the anastomosis play a similar role. Measuring the diameter of the gastroenterostomy during examination should be a routine part of interpretation of CT scans in patients who underwent malabsorptive bariatric interventions. In these scans, administration of an oral contrast material just prior to the examination helps to diffentiate the gastric pouch, gastroenterostomy and alimentary limb (which are opacified) from the biliopnacreatic limb and enteroenterostomy (non opacified). This is essential for adequate interpretation of the cause of failure and also for 38 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner detecting potential events like internal herniation. Distention of the gastric pouch and collapse of the distal pouch are also important features. The normal peristaltic movements of the biliopancreatic limb protects from retrograde passage of contrast material or gases in this limb [29, 38]. Through oral contrast intake, conditions such as gastrogastric fistulation can be detected by abnormal flow of contrast in the distal gastric pouch. Similarly, with adequate localization of the gastric pouch and alimentary limb, blind loop formation (also at the site of the enteroenterostomy) may be seen. Although not typically diagnosed, marginal ulcerations have been reported to be detected on CT abdominal scans [39]. THREE DIMENSIONAL CT ASSESSMENT A corner stone in accurate assessment of failure after bariatric intervention is the proper outlining of anatomical changes in the gastro-intestinal tract, which allows to choose the best management or revisional modality. Previous studies reported that accurate assessment of pouch size enables the surgeon to design the best strategy and perform the best available intervention [40]. Here, we think that 3D pouch construction provides the best aid to the treating team. Despite reports that endoscopy, upper GI series and CT scans are the most commonly used assessment modalities [41-45], we believe that they don‟t offer sufficient data. Endoscopy is to some extent operator-dependent and routine CT is of a higher value in the evaluation of acute complications. Endoscopy is more invasive and is not free of complications. Moreover, insufflation of air during endoscopy may lead to over-distension of the gastric pouch [40]. The classical upper GI series can be useful in providing approximative data for pouch volumes. Langer and his colleagues postulated that a sleeve wider than 4 cm is considered to be dilated, but they did not estimate the sleeve volumes [46]. Three dimensional CT gastric reconstruction (together with alimentary limb reconstruction) represents in our opinion the best investigative modality for pouch and alimentary limb. Based on our experience, we affirm that this modality of investigation gives the most accurate reconstruction of the actual intra-abdominal anatomy. Sets required for this investigative modality should be an integral part of any center practicing obesity surgery. Although there were reports [47] comparing the accuracy of pouch measurements after gastric bypass using gastroscopic assessment versus those using 3D pouchography did not find statistically significant difference Diagnostic Tools in Failed Bariatric Procedures 39 between both measurements, we still stress on the superior value of 3D pouchography. As mentioned, interpretation of endoscopic findings can be operator dependent. Many authors support our opinion regarding the value of 3D gastric pouchography [48]. Technically, 3D pouchography entails drinking a powder or effervescent granules diluted with water after overnight fasting. Ingestion allows stomach distension with air. This distension helps in obtaining an actual picture for the current gastric (and alimentary limb) anatomy. Addition of a spasmolytic agent is indicated. Some authors prefer glucagon [47], others tend to use Buscopan® [40]. Thin slice scans (1 mm) are taken and three dimensional volume-rendering images created in a 3D workstation. The modality is described in different techniques using different contrast agents. [40, 47, 48] Some authors tend to use iodine containing contrast agents [40], others prefer effervescent granules without the use of iodine-containing oral contrast agents [47]. Some authors [47] resort to 3D pouchography to obtain base line data for future comparison in patients with non-satisfactory results after bariatric intervention. Through this modality a large and sufficient deal of information can be available which, if properly analyzed, usually allows for the best intervention to overcome the encountered failure after a bariatric intervention. A large pouch can be easily assessed (Figure 4). Figure 4. A large pouch after sleeve gastrectomy seen on CT pouchography. 40 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner Other abnormalities such as loop formation, a wide gastroenterostomy and a twisted pouch (Figure 5) can be readily diagnosed [40]. In addition, hiatal herniation, a common cause for complaints after bariatric intervention can be adequately diagnosed (Figure 6). Figure 5. A twisted pouch after sleeve gastrectomy. Other less readily detected pathologies, e.g., gastro-gastric fistulation are also readily seen in 3D pouchographies. Reports from different centers on cases of fistulation that failed to be diagnosed despite several gastroscopies and upper GI series have been published [40]. Moreover, computed tomography with 3D imaging has been shown to be of reasonable value in patients with previous gastric banding, because it allows to delineate the entire band, location and orientation, as well as related complications such as erosion, slippage and infection. Port-related complications may also be detected [49]. A possible limitation of this modality is ist inherent radiation exposure [50], although low dose exposure with a highly preserved quality can be achieved in recent stations [48, 51]. Some assume that the radiation dose used Diagnostic Tools in Failed Bariatric Procedures 41 in 3D CT imaging does not exceed the radiation dose in conventional CT scans [48]. Blanchet et al. mentioned additional limitations of this technique [48] i.e., the need for a recently equipped station, and the learning curve required for performing the study and interpreting its findings (although the latter usually does not exceed 10 minutes after achieving an adequate learning curve). Inadequate fasting or failure of adequate oral intake of the contrast agent [40], leads to incomplete distension of the pouch and inadequate interpretation of the results. Figure 6. Hiatal herniation, a common cause for complaints after bariatric intervention can be adequately diagnosed on CT pouchography. ROLE OF ENDOSCOPY IN FOLLOW-UP AND DETECTION OF FAILURES OR COMPLICATIONS AFTER BARIATRIC INTERVENTIONS Endoscopy plays a major role in the bariatric field in that it allows evaluation of symptoms attributed to complications or failures after surgery. In 42 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner an analysis of more than 7,000 restrictive and malabsorptive procedures 4 main complications were reported after restrictive prrocedures; pouch or stoma dilatation (2.4%), stomal stenosis (2.2%), staple line failure (1.5%) and stomach erosions (1.2%). These complications were also reported after malabsorptive procedures with incidences of 0.47%, 2.7%, 5.9% and 1.2% respectively. These figures denote the importance of follow-up endoscopy in assessing failures and complications after bariatric interventions [52]. That is why we recommend a scheduled follow-up endoscopy regimen after bariatric interventions. The diagnostic spectrum of gastroscopy in patients with failed bariatric surgery is very broad and better to be illustrated based upon which procedure is performed and its possible causes of failure or complications. Follow-Up Endoscopy after Roux-En-Y Gastric Bypass Patients with nausea, vomiting or dysphagia after RYGB should have a gastroscopic evaluation to rule out conditions like marginal ulceration in 2752% of patients followed by stomal stenosis in 4 -39% [53, 54, 55]. Stomal Stenosis An anastomosis is considered stenotic if the normal 9.5 mm endoscope cannot readily bypass it [56]. Stenosis has a reported incidence of 5-12% after LRYGB [57, 58]. Possible underlying factors for a stenotic gastrojejunostomy include local ischemia, the use of a circular stapler and local inflammation (by smoking for example) [56]. In case of stenosis in the presence of active marginal ulceration ulcer treatment should be initiated prior to dilatation of the stenosis to avoid inadvertent perforation during the dilatation sessions [56]. An intended diameter of dilatation to avoid symptomatic recurrence is 15 mm [59]. An important point to be considered here is to adequately assess the proximal part of the alimentary limb to rule out any associated pathology or active ulceration. Endoscopic dilatation can be safely started 4 weeks post-operatively [59, 60] and is usually performed using balloon dilatation through a bougie passed over a guide wire. Guide wire guidance is essential when a bougie cannot be readily passed through a stenotic stoma [56]. Torsion, angulation of the stoma and marginal ulceration are all underlying factor for failed dilatation. Diagnostic Tools in Failed Bariatric Procedures 43 Marginal Ulceration This condition is reported to vary in incidence from 0.6-16% [45]. Marginal ulcers are asymptomatic in more than 20% of cases [58]. Ulcer development is limited to the intestinal side of the anastomosis [56]. An important predisposing factor for marginal ulceration and pouch inflammation is H.Pylori infection. Although not highly sensitive, mucosal biopsies should be taken prior to and during every follow-up endoscopic session after RYGB, and the same applies to all bariatric interventions. A proved infection should be thoroughly treated and follow-up endoscopy after eradication is a routine practice in our patients. Other factors than H. Pylori infection have been strongly linked to marginal ulceration. These factors may be either intrinsic or extrinsic. The former include pouch acid production, pouch ischemia and gastrogastric fistula due to retrograde passage of acid produced from the distal pouch into the constructed pouch and subsequently over the site of the anastomosis. The latter include smoking and alcohol consumption. Pouch and Stomal Dilatation and Blind Loop Formation This triad represents an important cause of failure after RYGB. In this case failure is determined by insufficient weight loss or weight gain. Through any of those three causes, an abnormally large amount of food will be ingested and rapidly dumped distally. This can simply be explained by loss of restriction. During endoscopy, length of the pouch (distance between the gastro-oesophageal junction and the stoma) can be readily measured. Despite the fact that the diameter of the stoma can be assessed by experience of the endoscopist, it cannot be actually measured. Thanks to the advances in interventional endoscopic techniques, the spectrum of endoscopic applications exceeds the diagnostic level and reaches the therapeutic level. Techniques as the endoscopic overstitch are currently practiced in our clinic, but results are still in the evaluation phase. Gastro Gastric Fistulation An important cause of failure after RYGB is the formation of a gastrogastric fistula. A channel is gradually formed between the proximal and distal gastric pouches. This condition has two effects. First, the restrictive effect of RYGB is lost due to the passage of food stuffs from the proximal pouch into the distal pouch which causes the patients to tolerate larger 44 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner volumes of meals. Second, the retrograde passage of acid from the distal into the proximal pouch results in exaggerated effect of gastric acid on the constructed stoma, with consequent oedema, ulceration and stenosis. This event is not easily found during routine endoscopy performed by nonexperienced personnel. As previously mentioned, pouchography plays a major role here. Still, besides its possible therapeutic role, endoscopy can assess this situation, and get access to the distal stomach pouch. Follow-Up Endoscopy after Sleeve Gastrectomy: (Figure 7) Stenosis of the Sleeve Although uncommon, stenosis is a serious complication after sleeve construction. We experienced cases with severe nutritional impairment due to sleeve stenosis, up to Beri Beri and Wernicke‟s encephalopathy. Stenosis is most common at the incisura angularis. In our opinion, gastroscopy can help in evaluation of a stenotic sleeve. It is noteworthy that the stenotic segment can be overlooked when the endoscope, when it crosses the stenosis thanks to its mere weight. This is why we recommend pouchography for the accurate assessment of the stenotic segment before ruling out sleeve stenosis (Figures 8, 9, 10) Figure 7. Follow-up endoscopy after sleeve gastrectomy showing a gastric fistula. Diagnostic Tools in Failed Bariatric Procedures Figure 8. Figure 9. Figures 8, 9, 10. (Continued). 45 46 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner Figure 10. Figures 8, 9, 10. Sleeve stenosis as seen on CT pouchography. Sleeve Dilatation Long-term results after sleeve gastrectomy are not universally satisfactory in terms of weight loss and weight regain has been reported in 75% of the cases [61]. This finding has been correlated with increased sleeve volume. Consequently assesment of the sleeve volume in late follow-up sessions is of utmost importance. Patients presenting for evaluation of weight regain or nonsatisfactory weight loss undergo a standardized assessment that mainly includes endoscopic assessment followed by pouchography. During endoscopy, a wide sleeve, allowing swift retroflexion or inversion of the gastroscope, usually indicates an increased sleeve volume. Accurate measurement of the sleeve volume and shape however cannot be accomplished by endoscopy. The full assessment usually proceeds to pouchography to delineate the new sleeve shape. Diagnostic Tools in Failed Bariatric Procedures 47 Follow-Up Procedures After Malabsorptive Procedures (Biliopancreatic Diversion, BPD) As for RYGB, pouch assessment (whether a large pouch of 200-500 ml size in BDP Scopinaro or a tubular sleeve in duodenal switch) and stomal inspection can be endoscopically performed. Biopsies from a marginal ulcer or for detection of H. Pylori gastritis, or from ileal mucosa can be easily achieved. Conditions involving stomal stenosis, pouch dilatation or blind loop formation are very amenable. Follow-Up Procedures After Vertical Banded Gastroplasty Vertical banded gastroplasty is no longer a common bariatric practice. This procedure remains interesting because of the common presentation of patients with history of vertical banded gastroplasty who suffer from problems related to the functional failure of this procedure. A high pressure created by a stenotic distally applied ring or mesh is cranially propagated. This leads to a common triad of presentations; gastro-oesophageal reflux, pouch enlargement (new stomach) and gastro-gastric fistula. The latter two phenomena are associated with loss of restriction with resultant weight gain. All these changes can be detected endoscopically. Again, the accurate volumetric assessment is better achieved by pouchography. Follow-Up Procedures After Gastric Banding At endoscopy a normally functioning non-complicated band in retroflexion appears as a belt surrounding the gastroscope. However, two important conditions have to be carefully assessed after gastric banding; band erosion and band slippage. We discussed before band slippage, a condition that as mentioned before is better assessed by upper GI series. Band erosion is also diagnosed by upper GI series, but endoscopy here seems tob e a better diagnostic tool. Band erosion has been reported in rates ranging up to 2.8%. [62] Band erosion is a gradual process involving penetration of the tight band into the gastric wall. The blackish discoloration of the eroding segment is pathognomonic and is possibly due to the burning effect of gastric acid on this segment. 48 Rudolf Weiner, Islam A. El-Sayes and Sylvia Weiner Patients suffering from band erosion usually present with a gradual loss of the restricting effect of the gastric band. Sometimes the first manifestation of erosion is tenderness or infection of the port of the migrating band, due to ascending infection along the tubing system. Endoscopy can be both diagnostic and therapeutic in these cases, as band extraction can be completed endoscopically provided more than 50% of the band circumference is eroding inside the stomach lumen [56]. Endoscopy and Hiatal Hernia After Bariatric Intervention A commonly encountered event after bariatric intervention is hiatal herniation. Either this herniation was already present at the time of the primary intervention, or it developed by disappearance of the fat pad surrounding the cardia as a part of weight loss after bariatric surgery. This leads to the classical symptoms of hiatal herniation presenting as epigastric discomfort, dysphagia or reflux manifestations. Endoscopy has been broadly used in the diagnosis of this type of sliding hiatal herniation. Herniation can be assessed by one of two methods [63]: either by measuring the distance between the squamocolumnar transition and the diaphragmatic impression (usually considered when more than 3 cm), or by inspecting the impression of a patulous diaphragmatic sphincter by a retroflexed endoscope). Endoscopy and Reflux Disease After Bariatric Intervention Another important cause of failure or dissatisfaction after bariatric intervention is the development of gastrooesophageal reflux disease. Patients usually present with typical manifestations including dull aching upper abdominal pain, heart burn, vomiting and dysphagia with in extreme cases reflux of gastric juice through the nose. We saw many cases presenting with intolerable reflux manifestations, mainly after sleeve gastrectomy. That is why diagnosis of gastro-esophageal reflux disease should be a routine part of follow-up after bariatric intervention. Differential diagnostic points include other medically-treatable causes (e.g.: H. Pylori induced gastritis and marginal ulceration, etc.). After ruling out all medical causes, and after failure of medical management of reflux, a surgical approach may be required, for example conversion of a sleeve into RYGB. The role of endoscopy in this Diagnostic Tools in Failed Bariatric Procedures 49 condition should be respected. The presentation with the typical findings of reflux on endoscopy is diagnostic with a specificity of about 95% [64, 65]. Role of Diagnostic Laparoscopy in Assessment of Failure After Bariatric Intervention: (Figures 11, 12) Laparoscopy constitutes one of the best diagnostic (and at the same time therapeutic) modalities. Some patients are presented with failures or complications after bariatric interventions that remain unexplined despite a full diagnostic work-up. 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Am J Med Sci. 2003 Nov;326(5):300-8. In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 4 ADJUSTABLE GASTRIC BAND FAILURES J. W. M. Greve Bariatric and gastrointestinal surgeon, Medical director Dutch Obesity Clinic South Department of Surgery, Zuyderland Medical Center Heerlen and Orbis Medical Center Sittard, Heerlen, the Netherlands ABSTRACT The adjustable gastric band is a good treatment option but requires a strict follow up and good compliance of the patient. Despite good results failures do occur either due to technical failures or patient noncompliance. Failure can also be a result of band complications. In many cases surgical revision is possible either by repositioning of the band or replacement of the band. A back on track program and band adjustments can also result inrecovering an initial good result. In case of band failure conversion to another technique is shown to be safe and effective. A good treatment strategy is based on the conclusions of a mandatory multidisciplinary team. Failure of an initially successful band is rather a phase in a life long obesity treatment program and not a disqualification of the band as valid treatment option. E-mail address: [email protected]. 58 J. W. M. Greve 1. INTRODUCTION In search for a safe and effective surgical treatment for morbid obesity the idea of an adjustable band was developed. As early as 1982 a first paper on adjustable gastric banding was published and mid eighties of the past century a workable device was constructed and used clinically [1, 2]. Laparoscopic placement made it a very successful and frequently used device (Cadiere, Belachew) [3, 4]. Many types of the adjustable silicone gastric band (ASGB) have been developed over the years. The most important improvement was a change from low volume high-pressure bands to high volume low-pressure bands, which reduced the risk of erosion significantly. Placement of the band in the early days was peri-gastric creating the retro gastric tunnel by dissecting at the lesser curve of the stomach. This technique had a significant erosion rate probably due to micro lesions of the stomach wall. Moreover due to placement through the lesser sac with a relatively large pouch slippage and pouch dilation were a frequent problem. These problems were significantly reduced by introduction of the pars flaccida technique [5]. Over the years it has been shown that follow up is crucial in a successful treatment program in patients with an adjustable gastric band. There is a significant correlation between frequency of follow up and weight loss as was shown by Ren and colleagues [6]. Several algorithms have been proposed to improve outcome, in particular on when and how to adjust the band. The green zone concept by O‟Brien based on clinical parameters is the most effective, but other options are available such as adjustments based on balloon pressure as proposed by Fried [7]. When all criteria are fulfilled (correct placement, correct type of band and an optimal follow up program) good long term results (>5 years) can be achieved that are comparable to the gastric bypass [8, 9]. Currently however, most bariatric surgeons no longer consider the adjustable band as a viable treatment option. Long term results from early series with inferior band types and poor follow up programs show very poor results with a high percentage of revisions and band removals and few patients with sufficient long-term weight loss. Poor results and the introduction of “easy, no worry, procedures” such as the gastric sleeve resection has resulted in dramatic reduction of band placements, partly under pressure of the public opinion. Nevertheless with a good patient selection and a good follow up program the adjustable band is still a very valid treatment option. As all bariatric procedures the adjustable band is not flawless. Even in good programs problems may occur that need correction. Moreover more than 800,000 bands have been placed worldwide which means that, even with low Adjustable Gastric Band Failures 59 failure rates, there will be a significant number of patients that may need a revision or conversion of the procedure. 2. BAND FAILURES Failures of the band can be divided in several categories. Primary failures pertain to patients who never reach a desired weight loss, which can be due to a technical problem (high band position, large size of the band, malposition of the band, mechanical defect of the band etc.) or due to non-compliance of the patient (poor diet habits, failure to adhere to the follow program). A second category consists of the patients who had a successful weight loss but then regained weight. This can be due to a mechanical failure (band leakage, tubing or port disconnection, tubing breakage), slippage of the band or pouch dilation or changed dietary habits of the patient while some patients develop band intolerance. A third category consists of the patients with a band complication, a condition that often needs acute intervention. Examples are acute herniation of the stomach through the band, acute obstruction, erosion of the band, internal herniation of bowel around the tubing but also severe reflux and/or esophagus dilatation. 3. GENERAL CONSIDERATIONS IN REVISION OR CONVERSION When a surgical procedure is required to improve the outcome of the patient this can either be a revision/correction of the current procedure (e.g., band reposition, band replacement, port revision etc.) or a conversion to a different type of procedure [10]. Reversal is in itself an easy procedure but should only be considered on explicit patient request or under rare circumstances. Just removing the band will without exception result in weight regain and loss of the positive effect on the co-morbidities. If a band is removed it is advisable to take down the entire plication (gastro-gastric sutures) in case the patient reconsiders and comes back for a new bariatric procedure. In all patients careful evaluation by a multidisciplinary team including a dietician, psychologist and bariatric surgeon is mandatory. This may help to identify patients who have a deteriorated eating pattern or inappropriate life 60 J. W. M. Greve style changes. In these patients a “back on track” program and careful adjustment of the band may be sufficient. However multidisciplinary team evaluation can also assist in the decision on which strategy to follow when a revisional procedure or a conversion to another technique is required. Next to evaluation of patient behavior upper gastrointestinal X-ray and or endoscopy are required to detect technical failures or band complications. The final decision for an intervention should always be based on evaluation of all results by the multidisciplinary team. 4. PRIMARY FAILURE Primary failure as a result of a technical failure should be evaluated carefully. In all patients dietary counseling is mandatory as well as evaluation of filling volume of the band. Life style modifications need to be recorded as well. Diagnosis based on these results is a multidisciplinary team effort. X-ray and or endoscopy are required to exclude a technical problem. If there is a band malfunction (leakage, band not closed) or malposition of the band (band not around the stomach) a revision of the band is required by either replacement of the band or repositioning. In case of a high band position (no stomach above the band, Figure 1C) successful reposition of the band is unlikely and conversion to another procedure is required. Available options are Roux en Y gastric bypass (RYGB), sleeve gastrectomy (SG), biliopancreatic diversion (BPD), duodenal switch (DS) or omega loop gastric bypass. More recently some surgeons have added a gastric plication to the band but long term results are not available yet [11]. Conversion of a failed restrictive procedure to a new type of restrictive procedure is less likely to be successful. However, several authors have reported good outcomes of conversion to a SG. Nevertheless, in most series conversion to a RYGB is considered the gold standard and good outcomes are reported [10, 12]. Optionally conversion to RYGB can be done while leaving the band in place for future adjustments (adjustable banded RYGB) [13]. Although BPD and DS are feasible not many surgeons are in favor of this options [14, 15]. This is also true for the so called “Bandinaro” in which the band is left in place [9]. Adjustable Gastric Band Failures 61 Figure 1. Upper GI X-ray of band related complications. A: posterior slippage with vertical band position. B: anterior slippage with horizontal band position. C: primary failure with high band position (no gastric pouch). D: acute herniation of the stomach through the band. 4.1. Conversion to Sleeve Gastrectomy Since its introduction the nowadays very popular SG procedure is being used as rescue operation for the ASGB. It has been shown to be feasible and relatively safe although severe complications have been reported with a significant percentage of leaks and fistulas that are difficult to treat [16]. The 62 J. W. M. Greve procedure can be done in 1 or 2 stages with a lower reported complication rate in the latter strategy [17, 18]. Successful weight loss is reported ranging between 31-60%EWL however there is an increased complication rate with leaks in up to 6% [10]. In a paper by the group of Rosenthal et al. comparing RYGB with SG after band it was found that in non-responders (primary failure) conversion to RYGB was more successful than SG [19]. 4.2. Conversion to RYGB Most reported series on treatment of a failing ASGB treat conversion to RYGB. In particular, in primary failures (non-responders) successful treatment is more likely with a bypass [19]. Similar to conversion to a SG a 2-stage procedure may be more safe but a large number of publications have shown the efficacy and safety of conversion to a RYGB in 1 stage [12]. Outcome after conversion to RYGB is comparable to the results of a primary RYGB with similar or slightly higher complication rates [12, 20]. 4.3. Conversion to Adjustable Banded RYGB Restriction is an important part of the working mechanism of a RYGB. Several studies have shown a benefit for a non-adjustable band placed around the pouch of the RYGB as reported by Fobi in open RYGB and more recently by Bessler in laparoscopic procedures [21, 22]. Furthermore, placement of an adjustable band around the gastric pouch of RYGB patients with weight regain was shown to be a valid option [23]. In patients with banded pouch after SAGB, all studies reported further weight loss, varying from 55.9%–94.2% excess body mass index loss (EBMIL) after 12–42 months of follow-up (Figure 2). With these considerations in mind a logical step was to leave the band in place when conversion to a RYGB was indicated, to prevent pouch dilation and to add the option for adjustments. Feasibility of this strategy has been demonstrated but larger studies with long term follow up are needed [13]. Potential problem with this treatment mode is that the band may add complications to a regular gastric bypass such as slippage, infection and erosion of the band. Most important is to protect the band from contact with the small bowel as was shown in the past with the adjustable RYGB. Adjustable Gastric Band Failures 63 Figure 2. Salvage of failing RYGB with an adjustable band on the pouch. Excess body mass index loss (%EBMIL) after revision. Values shown for follow-up (in months) after revisional surgery (t _ 0) [23]. Figure 3. Functional or adjustable gastric bypass. A procedure with a high risk of band erosion to the small bowel [24]. 64 J. W. M. Greve This was a procedure in which the pouch above the band (allowing access to the remnant stomach by opening the band) was used to anastomose the jejunum to (Figure 3). This resulted in a high erosion rate into the small bowel and the procedure was abandoned after careful evaluation [24]. In conversion of a band to adjustable band RYGB the excluded stomach can be used to create a Nissen like plication distal to the band (Greve plication) to prevent slippage and avoid contact of the SAGB with the small bowel (Figure 4). Figure 4. In conversion of a band to adjustable RYGB the excluded stomach can be used to create a Nissen like plication distal to the band (Greve plication) to prevent slippage and contact of the SAGB with the small bowel. Adjustable Gastric Band Failures 65 5. SECONDARY FAILURE Secondary failure is defined when patients who had an initial good weight loss and resolution of co-morbidities experience significant weight regain. Causes can be patient related (diet, life style) or due to a technical problem. Minor problems such as port dislocation or port disconnection are not discussed here, as the solution is simple. The majority of secondary failures are related to pouch dilation or band slippage. In early series pouch dilation or slippage was a frequent problem in up to 40% of the patients [25]. Introduction of the pars flaccida technique has significantly reduced the incidence of slippage to 6.5% and less [8, 25]. 5.1. Failure Due to Patient Compliance or Due to Band Intolerance In patients with insufficient follow up or incorrect band adjustments (too tight or not tight enough) a “back on track” program and proper adjustment of the band may be an option. In particular a too tight band will result in wrong eating habits. These patients can develop reflux like symptoms and often are permanently hungry due to lack of satiety. Opening the band and re-education of the patient may work. However most patients will need a conversion to a different procedure. Options are discussed in subsection 4. 5.2. Mechanical Failure of the Band Although the adjustable bands are made of durable silicone, technical failures can occur. Breakage or unlocking of the band will result in loss of restriction and weight regain. Another cause of loss of restriction is breakage of the tubing, which is often due to material fatigue. Inserting a connecting piece can fix breakage of the tubing but it is probably better to replace the band as is the case with a broken band. Leakage of the balloon can also occur. In particular in some of the older band types (Swedish band) a fold in the balloon could cause a perforation of the balloon at inflation. 66 J. W. M. Greve 5.3. Pouch Slippage or Dilation Definition of slippage versus pouch dilation is difficult and not relevant for the treatment. After counseling by the multidisciplinary team and proper diagnosis by radiology initial treatment can be band deflation. If there is a spontaneous reposition gradual insufflation of the band can be attempted [26]. Failure of reposition after deflation or recurrence of slippage is an indication for band reposition in patients with good weight loss. Good results have been reported also on the long term with this policy [27, 28]. In the early days posterior slippage (band in a vertical position, Figure 1A) was a frequently encountered problem with the perigastric technique. Replacing the band using the pars flaccida approach can solve this issue. In the more common anterior slippage (band in a horizontal position, Figure 1B) laparoscopic repositioning is in general successful. An important technical aspect is the release of all gastro-gastric sutures and the gastric plication all the way to His‟ angle. In most cases the band can be opened and re-used. After correction of the position, fixation of the band by plication of the fundus to the pouch with a minimum of 4 non-absorbable sutures is required. Symmetrical pouch dilation probably requires conversion to RYGB because successful repositioning is less likely [26]. 5.4. Gastro-Esophageal Reflux (GERD) Secondary GERD is usually a result of a too tight band with stasis and regurgitation of food into the esophagus. Opening the band may resolve this condition. In some patients a hiatal hernia may have developed de novo or was missed during band placement. Correction by closing the hiatus and repositioning of the pouch is an option [29]. However, in general in patients with severe reflux symptoms conversion to a RYGB with, if applicable, repair of the hiatal hernia is considered to be the best option [30]. 6. BAND COMPLICATIONS AND TECHNICAL FAILURES 6.1. Revision After Band Erosion Band erosion can be early or late. Early erosion is most likely due to a lesion of the stomach wall at insertion or a secondary infection of the band. Adjustable Gastric Band Failures 67 Late erosion can be due to over-inflation of the band but often no clear explanation is found. Symptoms are upper abdominal pain, loss of restriction and sometimes the opposite, food intolerance. Fever may occur and inflammation around the port of the band is often a first symptom of band erosion. Diagnosis is confirmed by gastroscopy, followed by CT scan that can be helpful to identify a large inflammatory mass. Treatment strategy is manifold. Once the diagnosis is confirmed the band can be removed (endoscopically or surgically). Endoscopic band cutting tools can be used for endoscopic removal but in that situation the port of the band needs to be removed first [31]. Port removal is in general advised to prevent complications due to the tubing when the band migrates in total to the stomach with the port still attached. Surgical removal is the most used option, the laparoscopic approach being the preferred one. It is possible to immediately convert to another procedure such as repair of the gastric wall defect and placement of a new band or conversion to gastric bypass [32, 33]. Alternatively after removal of the band and closure of the defect a biliopancreatic diversion can be constructed in the same session, avoiding an anastomosis in an infected and inflamed area. However, in most cases band removal and revision some 3-6 month later is preferred. When the patient benefited from successful weight loss with the band, rebanding may be attempted. After band erosion, conversion to RYGB is nevertheless preferred and, as mentioned before, long-term results are good. In fact a 2-stage procedure allows conversion to any type of bariatric procedure later on. A 1-stage conversion to SG or RYGB is not advised because of the high complication risk, in particular leakage. 6.2. Band Obstruction Obstruction of the band may be due to a large food particle, a bezoar or may be due to acute herniation of the stomach (see below). Symptoms are food intolerance, inability to drink and regurgitation of saliva. Occlusion of the outlet can be solved by deflation of the band or by endoscopic removal of the foreign body or food particle. Bezoar is rare but can be more problematic and, if large, may even need surgical removal. Prevention by avoiding the ingestion of indigestible fibers (asparagus, oranges etc) is key. 68 J. W. M. Greve 6.3. Acute Herniation of the Stomach When a patient after ASGB develops sudden food intolerance and epigastric pain he/she should be considered an emergency. When a significant part of the stomach herniates through the band incarceration of the stomach can occur with high risk of necrosis and perforation. An upper GI contrast study or even a plain abdominal X-ray is diagnostic (Figure 1D). Immediate deflation of the band followed by emergency laparoscopy is needed. At laparoscopy the band can be opened and the stomach, when ischemic but not necrotic, can be left in place for a re-laparoscopy and repositioning of the band several days later. Alternatively the band can be removed and the patient planned for elective conversion to another procedure. CONCLUSION There is a distinct group of patients that can effectively be treated with an adjustable silicone gastric band, which remains a safe and effective operation. However, as there is not one single surgical procedure that will be permanently effective in any patient, revisions and conversions will be required. Patients who had a good result with the SAGB but who have either a mechanical failure or a secondary pouch problem can be treated effectively by surgical correction. It is also shown that when a band fails conversion to another technique is safe and effective. 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Calmes, Band erosion after laparoscopic gastric banding: occurrence and results after conversion to Roux-en-Y gastric bypass. Obes. Surg., 2004. 14(3): p. 381-6. In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 5 FAILED SLEEVE GASTRECTOMY Ricard Corcelles, MD, PhD, and Antonio Lacy1, MD, PhD Insititute of Digestive and Metabolic Diseases. Gastrointestinal Surgery Department, Hospital Clinic Barcelona, Barcelona, Spain ABSTRACT In the last 15 years, LSG has become increasingly popular as a primary procedure because of its simplicity, relative safety, and effectiveness to achieve sustained weight loss over time. LSG has demonstrated its effectiveness in achieving weight loss and resolution of obesity related co-morbidities. Despite good success rates, it may occasionally be associated with failure. LSG failure is defined by insufficient weight loss, weight regain, surgical complications, and poor control of comorbidities such as gastro-esophageal reflux disease (GERD). As demand for LSG increases, so will the need for revisional surgeries. The incidence of revision varies according to the studies analyzed but revision rate following primary LSG is reported to be between 5-30%. Revisional surgery is technically more demanding, and associated with higher complications and mortalities compared to primary Ricard Corcelles: Insititute of Digestive and Metabolic Diseases. Gastrointestinal Surgery Department, Hospital Clinic Barcelona, Barcelona, Spain. E-mail: [email protected]. 1 Corresponding author: Antonio Lacy, MD, PhD. Insititute of Digestive and Metabolic Diseases. Gastrointestinal Surgery Department, Hospital Clinic Barcelona, Barcelona, Spain. E-mail: [email protected]. 74 Ricard Corcelles and Antonio Lacy bariatric procedures. Complication rates between 0 and 46% have been reported after these reoperations. In this chapter, we will analyze the potential causes of LSG failure as well as the suggested revision surgeries. 1. INTRODUCTION Sleeve Gastrectomy was first created by Hess and Marceau in 1998 as the first part of the duodenal switch (DS) operation [1, 2]. In high risk and supersuper obese patients, the gastric sleeve part of the DS operation was often performed alone in an attempt to reduce morbidity and mortality, and to facilitate the laparoscopic approach [3]. Owing to the relative technical ease, low complications rates and good weight loss results, it was found that laparoscopic sleeve gastrectomy (LSG) could be performed in many cases as a stand-alone bariatric operation [4]. Technical details of LSG vary, but the ultimate goal of the procedure is to remove the vast majority of the stomach, especially the fundus, leaving only a thin gastric tube from the esophagus to the duodenum. The absence of gastro-intestinal anastomosis during the operation, and leaving patients with an intact gastrointestinal (GI) tract are other potential benefits of this relatively new technique. In the last 15 years, LSG has become increasingly popular as a primary procedure because of its simplicity, relative safety, and effectiveness to achieve sustained weight loss over time. A recent meta-analysis data by Buchwald and colleagues suggests LSG is the second leading bariatric operation in the world, only surpassed by laparoscopic Roux-en-Y gastric bypass (LRYGB) [5]. As demand for LSG increases, so will the need for revisional surgeries. In this chapter, we will analyze the potential causes of LSG failure as well as the suggested revision surgeries. 2. LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) FAILURE LSG has demonstrated its effectiveness in achieving weight loss and resolution of obesity related co-morbidities [6]. Despite good success rates, it may occasionally be associated with failure. LSG failure is defined by insufficient weight loss, weight regain, surgical complications, and poor control of comorbidities such as gastro-esophageal reflux disease (GERD) [7, Failed Sleeve Gastrectomy 75 8]. LSG patients appear to be subjected to weight regain after more than 3 years. Himpens et al., noted that more than 30% of the LSG patients had inadequate weight loss or weight regain, requiring an additional procedure [9]. This is similar to what has been reported with other restrictive weight loss operations such as the adjustable gastric band (AGB), or the vertical banded gastroplasty (VBG) [10, 11]. Several factors may be responsible for late weight regain after sleeve gastrectomy. These factors include dietary factors, and changing eating habits to high caloric meals. Long term anatomic changes with the sleeved stomach dilatation might allow the patient to consume larger amounts of food, thus contributing to weight regain as well [12]. Furthermore, loss of patient follow-up and counseling, may also play an important role in weight regain. Surgical complications after LSG can lead to procedural failure [8]. A recent systematic review of the literature on LSG including a total of 15 studies (n = 940 patients) revealed overall complication rates of 12.1%. Reported complications include bleeding or leakage from the staple line, strictures, delayed gastric emptying, gastric dilation, and vomiting [13]. LSG failure is however multifactorial and finds a feeding ground in patient‟s poor adherence, procedure failure, and surgeon error. 3. REVISIONAL SURGERY AFTER LSG FAILURE The prevalence of revisional surgery increases as the number of LSG procedures rises. The incidence of revision varies according to the studies analyzed but revision rate following primary LSG is reported to be between 5% and 30% [9]. Revisional surgery is technically more demanding, and associated with higher complications and mortality compared to primary bariatric procedures. Complication rates between 0 and 46% have been reported after these procedures [7]. Revision of previous bariatric operations carries a higher overall risk of leakage. A review of revisional bariatric surgeries conducted by Jones et al., (n = 838 patients) reported a 14% (n = 118) major complication rate and 0.8% (n = 7) mortality rate. The study also noted that complication rates were lower in the laparoscopic patients with no mortalities in this group [14]. This challenging scenario obligates bariatric surgeons to have solid options in revisional surgery after LSG failure [15-19]. Revisions are technically demanding due to the increased tissue fibrosis and the altered anatomy following the primary procedure [20]. The currently accepted alternatives for the patients who require revisional surgery for failed LSG are detailed as follows. 76 Ricard Corcelles and Antonio Lacy 3.1. Laparoscopic Re-Sleeve Gastrectomy (LRSG) Laparoscopic re-sleeve gastrectomy (LRSG) was initially reported in 2003 as revision for poor weight loss after DS [21]. Since its first description by Gagner et al., several case series have been published [13]. Baltasar et al., showed feasibility of LRSG in the super-super obese patients, when the resulting gastric pouch is too large or dilated after the original LSG [12]. Another retrospective study included 13 patients with ineffective weight loss (%EWL < 50%) or weight regain who underwent LRSG. All patients underwent a preoperative upper GI series showing persistent fundus at the time of revision. Weighted mean preoperative body mass index (BMI) and excess weight were 44.6 kg/m2 and 61.8 kg, respectively. After 12 months follow-up, mean BMI, percent of EWL, and percent of BMI loss decreased to 27.5 kg/m2, 71.4%, and 82.8%, respectively. There was no morbidity reported [16]. However, LRSG results are far from being complications free, and complications at time may be severe in nature [22]. Within a smaller case series study (n = 7) of patients undergoing LRSG Dapri et al., reported one leak at the angle of His, and less successful weight loss than for primary cases [15]. Interestingly, Rebibo et al., retrospectively evaluated outcomes in 15 patients having LRSG after failure of LSG [18]. These patients were matched (age, gender, BMI, and co-morbidities) 1:2 with patients undergoing first line LSG. The mean operating time was longer in the LRSG (116 vs. 86 min; p ≤ 0.01), and postoperative complications were higher in the re-sleeved patients. Two patients experienced leakage and one died. At 12 months the EWL was 66% for the LRSG and 77% for the primary LSG group (p = 0.05) [18]. The results of the above mentioned studies suggest that LRSG can achieve significant short-term weight loss at 24 months follow-up but at the cost of substantial peri-operative complications. 3.2. Laparoscopic Gastric Bypass (LRYGBP) or Omega Loop Mini Gastric Bypass (LMGB) The conversion of a failed LSG to laparoscopic gastric bypass (LGB), considered by many the “gold standard” bariatric procedure, has been accepted as a revisional option because of the reasonable balance between weight loss and complications. A recently published systematic review of revisional surgery following failed primary LSG reported weight loss improvement in more than 100 patients (6 studies) with laparoscopic gastric bypass (LGB) Failed Sleeve Gastrectomy 77 (laparoscopic Roux en Y gastric bypass (LRYGB) or omega loop mini gastric bypass (LMGB)) as a revisional procedure [23]. Mean preoperative BMI was 41.9 kg/m2, which decreased after conversion to 38.9 kg/m2 at 3 months, 36.5 kg/m2 at 6 months, 33.7 kg/m2 at 12 months, and 35.7 kg/m2 at 24 or more months of follow-up. Percentage of EWL was 48% over the last follow-up period (i.e., 24 months). Similar trends in weight loss results have been recently published with 21 patients undergoing LMGB; a single gastro-jejunal bypass anastomosis connecting the gastric sleeve to a jejunal loop (200 cm downstream from the ligament of Treitz). Mean BMI at 12 and 24 months after LMGB was 34.6 kg/m2 and 35.7 kg/m2, respectively [24]. The Fourth International Consensus Summit on Sleeve Gastrectomy [25], a recent survey of 88 bariatric surgeons experienced in LSG (average of 295 operations per surgeon), reported that LRYGB was the preferred option if a second operation is required for weight regain after LSG [25]. Twenty % consider LRSG, 46% conversion to LRYGB and 24% conversion to BPDDS. However, strong evidence suggests weight loss outcomes after LGB are similar to those after LRSG. Cheung et al., [23], reported short-term weight loss outcomes after failed LSG. At 24 months, mean BMI and percentage EWL were 35.7 kg/m2 and 48%, for the LGB group (n = 114) vs. 35.3 kg/m2 and 44%, for the LRSG group (n = 45). The article review concludes there are no significant differences in weight loss improvement between both procedures. Langer et al., reported satisfactory results of 8 patients converted to LGB because of insufficient weight loss and severe reflux disease [17]. Interestingly, the authors emphasized that patients undergoing conversion to LGB after LSG could be more prone to regain weight. Perioperative complications after LGB as revisional procedure have also been reported. Moszkowicz et al., described a morbidity rate of 9.5% after LMGB [24]. A prospective case series study from the Netherlands (n = 18 patients) reported successful results within the LGB as a revision procedure in terms of weight loss, GERD, and dysphagia [19]. However, associated peri-operative complications were significantly high and included anastomotic leakage (n = 2), intra-abdominal bleeding (n = 2), splenectomy, wound infection, and cardiac decompensation. LSG has been reported to carry a risk of GERD. A retrospective study (n = 30) evaluated long term side effects after LSG. More than 20% of patients in the study reported severe GERD or vomiting at 6 years after the procedure [9]. Weiner et al., reports a 15% incidence of GERD in a cohort of 76 subjects, which was improved by conversion to LGB [26]. 78 Ricard Corcelles and Antonio Lacy In this clinical situation, conversion to LGB is a consistent option for management of GERD related complications after LSG (Figures 1-4). Figure 1. Conversion from LSG to LGB. Figure 2. Conversion from LSG to LGB; gastric sleeve dissection. Failed Sleeve Gastrectomy 79 Figure 3. Conversion from LSG to LGB; gastric pouch transaction. Figure 4. Conversion from LSG to LGB; gastrojejunal anastomosis. 3.3. Laparoscopic Biliopancreatic Diversion with Duodenal Switch (BPDDS) Sleeve gastrectomy was primarily planned as the first stage of a two stage duodenal switch, hence making the BPDDS a logical candidate for revisional surgery after SG. 80 Ricard Corcelles and Antonio Lacy However, patients who underwent LSG, as a premeditated and planned strategy for eventually performing BPDDS should not be considered as benefiting from a “true revisional procedure” for failure and are not analyzed in this chapter. LSG conversion to BPDDS has some potential advantages. There is no need to dissect and manipulate the stomach, which may ultimately decrease gastric leak rates, and other peri-operative complications compared to those observed in a primary BPDDS procedure. Single-stage BPDDS has been reported to have higher complications rates [27]. Iannelli et al., retrospectively compared 110 super-obese patients (BMI ≥ 50 kg/m2) undergoing the two staged DS with 110 patients (matched for age, gender and BMI) undergoing the single-stage DS [28]. The postoperative complication rate was 8.2% in the staged approach and 15.5% in the single-stage DS group. Multivariate analysis showed that singlestage DS was the only predictive factor of complications (odds ratio 2.36; 95% confidence interval 1.001-5.61) [28]. A small study evaluated outcomes in 9 patients with failed LSG converted to DS [15]. There were no conversions in the study but operative time was considerably long (mean 152.6 ± 54.3 minutes). Complications included one patient with bleeding, one patient with a duodenoileostomy leak, and one with a duodenoileostomy stenosis. Weight loss at 25 months follow-up was successful; mean 25 month BMI and percent EWL was 27.3 ± 5.2 kg/m2 and 73.7 ± 27.7%. During follow-up, 2 patients required revision due to hypoproteinemia and diarrhea (feeding jejunostomy tube) [15]. Thus, BPDDS as revisional surgery after LSG failure, promotes substantial weight loss improvement but at the cost of relatively high complication rates. 3.4. Miscellanea of Revisional Procedures After failed sleeve gastrectomy, some alternative procedures have been described in an attempt to minimize surgical complications and improve weight loss outcomes. Among these, single anastomosis duodenoileal bypass [29], plication of the sleeve [30], banded sleeve [31], butterfly gastroplasty (micro funnel shaped pouch) [32], and side to side jejunoileal anastomosis, are the most important. Results however continue to remain limited to case reports, and very small case series, hence no conclusions can be drawn. 81 Failed Sleeve Gastrectomy Figure 5. Proposed algorithm of treatment after LSG failure. Table 1. Failed Primary Laparoscopic Sleeve Gastrectomy Studies Author AbdelGalil* Chevallier Dapri Dapri Gautier Iannelli Langer Lech* Nienhuijs Year of Type of publication study n (size) Age (years) 2013 Case series 40 32 2013 2011 2011 2013 2011 2010 2013 Case series Case control Case control Case series Case series Case series Case series 38 7 19 15 13 8 10 49.5 44 47.2 39.7 40.3 35.8 n/a 2011 Case series 29 n/ Case series Case series n/a 15 18 6 47 46.5 42 2012 Rebibo Van Rutte 2012 Wadhawan 2013 * Only abstract available. Pre-op Revisional BMI Procedure (kg/m2) Butterfly 48 gastroplasty 44 LMGB 38.9 LRSG 36.9 BPDDS 40.9 LRYGB 34.9 LRSG 47 LRYGB n/a LRSG LRYGB and 45 open 41.5 LRSG 32.3 LRYGB 38 LRYGB 82 Ricard Corcelles and Antonio Lacy CONCLUSION In general, revisional surgery is technically more demanding than primary bariatric procedures, and must be performed with extreme care. Such operations should be carried out in tertiary centers with experienced bariatric surgery programs that can limit the incidence and severity of peri-operative complications. Furthermore, the selected type of revisional procedure should take three different considerations into account: the individual patient history and cause of failure, the difficulty of the revisional procedure, and the bariatric surgeon‟s experience. After thorough revision of the available literature, it appears that revisional surgery for LSG failure overall offers weight loss improvement at 24 months. In summary: while LRSG, and LGB appear to be reasonable options with well-adjusted results and complication rates, the conversion to a BPDDS appears to create an increased weight loss but at the cost of major morbidity. LGB can effectively manage intractable GERD after LSG. 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[27] Buchwald, H., Estok, R., Fahrbach, K., Banel, D., Sledge, I. Trends in mortality in bariatric surgery: a systematic review and meta-analysis. Surgery. 2007 Oct;142(4):621-32. PMID: 17950357. [28] Iannelli, A., Schneck, A. S., Topart, P., Carles, M., Hebuterne, X., Gugenheim, J. Laparoscopic sleeve gastrectomy followed by duodenal switch in selected patients versus single-stage duodenal switch for superobesity: case-control study. Surg. Obes. Relat. Dis. 2013 Jul-Aug;9 (4):531-8. PMID: 22498357. [29] Sanchez-Pernaute, A., Rubio, M. A., Perez Aguirre, E., Barabash, A., Cabrerizo, L., Torres, A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg. Obes. Relat. Dis. 2013 Sep-Oct;9(5):731-5. PMID: 22963820. [30] Abdelbaki, T. N., Huang, C. K., Ramos, A., Neto, M. G., Talebpour, M., Saber, A. A. Gastric plication for morbid obesity: a systematic review. 2012 Oct;22(10):1633-9. PMID: 22960951. [31] Karcz, W. K., Karcz-Socha, I., Marjanovic, G., Kuesters, S., Goos, M., Hopt, U. T., Szewczyk, T., Baumann, T., Grueneberger, J. M. To band or not to band--early results of banded sleeve gastrectomy. Obes. Surg. 2014 Apr;24(4):660-5. PMID: 24464518. [32] Abdel-Galil, E. S. A. Laparoscopic butterfly gastroplasty after failed sleeve gastrectomy in morbidly obese patient. Only abstract available. Obes. Surg. 2013; 238. In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 6 REOPERATIONS FOR ROUX-EN-Y GASTRIC BYPASS FAILURES Jacques M. Himpens1,, MD, PhD, and Ramon Vilallonga†, MD, PhD 1 Division of Bariatric Surgery, Chief of Department AZ St-Blasius, Division of Bariatric Surgery, Dendermonde, Belgium 2 Endocrine, bariatric and metabolic Unit, General Surgery and robotic Department, Consultant surgeon Universitary Hospital Vall Hebron, Universitat Autònoma de Barcelona, Endocrine, bariatric and metabolic Unit, General Surgery Department, Barcelona, Spain ABSTRACT The Roux-en-Y gastric bypass procedure is considered by many the “state of the art” bariatric intervention. Nevertheless, as any other weight loss/ metabolic operation it requires a strict follow up and good patient compliance to avoid the development of poor dietary habits. The most dreaded dietary flaw is without doubt sweets eating, which constitutes the Corresponding author: Division of Bariatric Surgery. Chief of Department. AZ St-Blasius. Division of Bariatric Surgery. Kroonveldlaan 52, 9200 Dendermonde. Belgium. Email: [email protected]. † Email: [email protected]. 88 Jacques M. Himpens and Ramon Vilallonga ruin for all bariatric procedures. Poor weight loss outcomes may however be the consequence of anatomical aberrations of the bypass construction as well. In addition, surgical complications may arise all along the postoperative course of the bypass patients. Complications and anatomical flaws may warrant surgical intervention to correct the anatomy, or, in some occasions, to radicalize the bypass or to convert the bypass to another type of bariatric/metabolic procedure. The decision to surgically re-intervene must be backed up by the conclusions of a multidisciplinary consultation. INTRODUCTION The Roux-en-Y gastric bypass (RYGB) is considered the gold standard for bariatric (“metabolic”) surgery. The procedure existed long before the laparoscopic infatuation and survived the rise of several upcoming fashionable operations such as the adjustable band (AGB) and the previously abandoned vertical banded gastroplasty (VBG) (the latter witnessed a revival because of the laparoscopic approach [1]) RYGB has undergone a substantial evolution over the years, both with the open, “classic” or the minimally invasive approach. In its initial embodiment RYGB as proposed by Mason [2] involved the creation of a horizontal stomach pouch, which, consequently, comprised a significant portion of the stomach fundus. With time, it became clear that the construction with horizontal stomach pouch was quite sensitive to dilation and subsequent failure. Newer versions of the RYGB, involving the use of the lesser curvature part of the cardia for pouch creation were popularized by surgeons such as Griffen [3]. With the advent of laparoscopy the technically quite complex RYGB procedure experienced a drop in popularity to the benefit of LAGB. In 1994 however Allan Wittgrove [4] and colleagues succeeded in performing a full- laparoscopic RYGB (LRYGB). Nevertheless, it took several years before the laparoscopic procedure benefited from general acceptance by the surgical community. Recently, the laparoscopic version of RYGB regained the pole position in terms of most popular and most performed bariatric operation [5]. Presently LRYGB is usually performed according to a few technical variations. Whereas initially the alimentary limb (AL) (Figure 1) was constructed some 150 cm long and the biliopancreatic limb (BPL) was kept rather short (which would allow endoscopic access to the excluded duodenum, stomach and biliary tree), more recently there is a tendency to reduce the length of the AL and to lengthen the BPL [6]. Reoperations for Roux-en-Y Gastric Bypass Failures 89 Figure 1. The typical “old fashioned” Roux-en-Y gastric bypass with relatively short biliopancreatic limb (BPL). The small gastric pouch (GP) is anastomosed to the alimentary limb (AL) that lies anterior to the stomach remnant (REMN) and the colon. The junction of AL and BPL results in the common limb (CL). This new modification allegedly increases weight loss and enhances the metabolic impact of the construction. In terms of anastomotic technique in RYGB, some surgeons prefer the handsewn technique [7], in contrast with others who choose the circular stapled technique [8] or the linear stapled technique [9]. Most surgeons by now close the potential hernia defects (Figure 2), but others claim that closure is not necessary [10]. 90 Jacques M. Himpens and Ramon Vilallonga Figure 2. The 2 most important defects created by the Roux construction: Petersen‟s defect (P) between the mesentery of the alimentary limb (AL) and the transverse mesocolon and the mesenteric gap situated between the mesenteries of the biliopancreatic (BPL) and the common limb (CL). Despite the popularity of LRYGB, many surgical teams recently made the switch to supposedly simpler procedures including the sleeve gastrectomy (LSG) and the mini gastric bypass (MGB), often called the omega loop or single anastomosis gastric bypass (OLGB, respectively SAGB). Of note, the “newer” procedures have not yet sustained the test of time and little is known about the long-term outcomes. Reoperations for Roux-en-Y Gastric Bypass Failures 91 Over the years it has been shown that follow-up is crucial for a successful gastric bypass. Adequate follow-up with periodical blood analysis is necessary, not only to dietary flaws (especially the abuse of carbohydrates and simple sugars), but also to detect the development of vitamin, mineral and protein deficiencies [11]. As all bariatric procedures LRYGB has some drawbacks. Even with good follow-up, problems may occur that need correction. Consequently, considering the high number of patients who have undergone LRYGB, it is inevitable that some individuals will need correction of the bypass construction for different reasons. It is the aim of this chapter first to analyze possible complications or unwanted side effects (such as insufficient weight loss and weight regain) that will need correction, and, second, to provide solutions to address this issue. 1. Types of Failures Failures of gastric bypass can be divided into several categories: Some patients never reach sufficient weight loss, which may be due to anatomical reasons or to lack of discipline of the patient (poor diet habits, failure to adhere to the follow-up program). These failures are considered primary failures. Some patients initially did experience successful weight loss but subsequently suffered weight regain. This evolution may be due to anatomical reasons (such as pouch dilation or gastrogastric fistula), but is most often caused by changed dietary habits of the patient. These failures are called secondary failures. Some patients suffer a complication that demands surgical correction. Examples of complication are intractable gastro-esophageal reflux (GERD), with or without hiatal hernia (HH), herniation of the gastric remnant through the hiatus, food intolerance because of long-term anastomotic stenotic problems, ulceration of the anastomosis, ulceration in the gastric remnant, blind loop symptoms at the level of the gastro-enteral or the entero-enteral (jejunojejunal or JJ) anastomosis, internal herniation with obstruction of the AL, the BPL or the common limb (CL), intussusception at the level of the alimentary-biliopancreatic confluent, trocar incision herniation, and problems concerning glucose metabolism, such as neuroglycopenia. 92 Jacques M. Himpens and Ramon Vilallonga 2. General Considerations in Revision or Conversion As in every bariatric-metabolic procedure it is essential to analyze the cause of failure of LRYGB,. Analysis must involve thorough evaluation of the anatomical integrity of the bypass construction. Anatomical alterations often may remain silent and not interfere with the clinical outcome. In face of poor clinical results, however, anatomical alterations should be addressed. Alterations may be situated in any of the components (i.e., the gastric pouch, shape or volume, the diaphragmatic hiatus, the length of the limbs). In some occasions the aberrant anatomy may be deemed too complicated and conversion to a different type of procedure (e.g., conversion to a distal RYGB) while keeping the gastric pouch and anastomosis as they are may be preferred. The most radical conversion procedure consists of reversal but should only be considered under rare circumstances. Simple reversal will most likely result in weight regain and resurgence of co-morbidities. Consequently, reversal procedures will most often be combined with conversion to a restrictive construction such as SG. Whenever a substantial change in anatomical construction is anticipated, a multidisciplinary team should be consulted to address all the aspects of the required therapeutic change. In our practice, the multidisciplinary team consists of a dietitian, a psychologist, a gastroenterologist, an endocrinologist, and, last but not least, the bariatric surgeon. Multidisciplinary evaluation is organized by the bariatric coordinating nurse, who because she personally knows the patients can best evaluate the capacity of the patient to deal with newly induced dietary restrictions, lifestyle changes, compliance with supplementation and medication and acceptance of a proposed new operation. The psychologist‟s task is to evaluate how the patient has progressed since the preoperative assessment. In some instances the patient will demonstrate a psychological incapacity or refusal to deal with the characteristics of the bypass. In contrast, sometimes the patient may have developed unrealistic expectations and must be taught to accept the actual outcome of the LRYGB in terms of weight loss, even when the outcome does not match his/her expectations. The patient must also be educated about the impact of a new surgical procedure that may, for example, significantly impair the capacity of ingesting food. This impairment may in some occasions surpass the psychological capacities of the individual. The dietitian analyzes the patient‟s dietary response to the bypass itself. When restriction is still active, some patients overcome the imposed small size of meals by increasing the frequency of meals (polyphagia). When restriction has weaned off, patients often Reoperations for Roux-en-Y Gastric Bypass Failures 93 experience the tendency to increase the size of their meals (hyperphagia) [12]. Alternatively, some subjects no longer observe the strict dietary restrictions such as the abstinence from sugars that were imposed at the time of surgery. Typically, some patients will preferably choose carbohydrates, especially liquid ones, because they no longer experience any dumping sensation - the alleged primary deterrent from ingesting sweets [13]. Typically, sweets eating will not warrant a surgical solution, because, as demonstrated by Scopinaro, this evolution is resistant to all bariatric constructions [14]. Consequently, the dietitian‟s main task consists of putting the patient back on the “right track.” The gastroenterologist and the radiologist evaluate the shape and volume of the different bypass components and will in addition check for possible significant changes such as marginal ulcers, HH, or gastrogastric fistula. Besides confirming the diagnosis made by the radiologist, the endoscopist may attempt to correct some of the detected anatomical aberrations and proceed to reducing the size of the pouch or trying to close a gastrogastric fistula. Interventional endoscopy has recently gained an important position in the correction of bypass failures but because of the novelty of the technique and lack of mid- to long-term outcome reports this aspect will not be further addressed in the present chapter. The endocrinologist investigates the possible insufficient improvement or resurgence of comorbidities, and, depending on the severity of the findings, may orient towards a surgical solution to address this issue. Conditions amenable to improvement with operative treatment include dyslipidemia, arterial hypertension (AHT) and type 2 diabetes (T2DM). When the aforementioned diseases have not substantially improved, or have re-emerged after initial remission or improvement either the patient‟s dietary compliance or the team‟s choice for the bypass procedure itself may be questioned. The bariatric surgeon must evaluate the safety of an anticipated reintervention, taking the specific history of the patient into account. Patients who postoperatively suffered a leak at the gastro-enterostomy for instance may not be ideal candidates for undergoing procedures involving the pouch part of the RYGB construction. Depending on the indication, the surgeon may decide to opt for a procedure that will influence the length of the limbs rather than to alter the volume of the pouch. The final decision for any bariatric reintervention should always be based on evaluation of all results by the multidisciplinary team. 94 Jacques M. Himpens and Ramon Vilallonga 3. Primary Failure Primary failures are rare after RYGB. Except for the cases where the patient displays an outrageous lack of dietary discipline, primary failures should always raise the suspicion of anatomical causes. In primary failures the most obvious culprit for poor weight loss is a poorly designed gastric pouch, that may have been constructed too large, or that has been made of parts of the stomach that are too distensible. Several strategies have been described to address this issue. 3.1. Reshaping the Pouch A poorly constructed gastric pouch (i.e., too large a pouch, or a pouch including the fundus) may be found, usually in patients who previously underwent another bariatric procedure such as LAGB or LSG, and in whom poor dissection of the apical part of the stomach results in the keeping of a large pouch, usually located posteriorly. Another possible anatomical cause for poor weight loss is the presence of a gastrogastric fistula, a condition that results in the abolition of the bypass physiology. The gastrogastric fistula may sometimes be the result of an imperfect transection of the stomach, usually located at the uppermost part of the staple line [15], but is most often caused by a perforating marginal ulcer, that connects the staple line of the anastomosis with the horizontal staple line on the remnant stomach [16]. Diagnosis and treatment strategy are based on a multidisciplinary approach. It is however noteworthy that in some occasions a gastrogastric fistula will only be discovered at surgical re-exploration. Correction of too large a pouch consists of extensive dissection of the gastric pouch, but only on the left sided part of the latter to avoid ischemic problems, because the blood supply essentially is provided by the vessels at the lesser curvature side of the stomach pouch. Usually the anastomosis itself can be kept as is. After complete dissection of the gastric pouch a re-resection can be performed under safe conditions, guided by a large bore gastric tube introduced by the anesthesiologist and kept in close contact with the lesser curvature of the stomach pouch. The resection of the pouch is best performed with a linear stapler with green or black load because the tissues invariably will be thickened. Alternatively, the fully dissected lateral aspect of the gastric pouch can be imbricated (or plicated), which has the advantage of being cheaper and possibly reduces the risk of fistula caused by staple line dehiscence. During reshaping of the pouch we usually perform dissection and resection of the fundic part of the remnant as well, in an effort to rule out all possible hidden Reoperations for Roux-en-Y Gastric Bypass Failures 95 gastrogastric fistula [17]. Typically, resection of the remnant will be carried out from the top down to the level of the antrum, i.e., to the right of the alimentary limb, because as mentioned above, a gastrogastric fistula of the posterior aspect of the gastro-enteral anastomosis (GEA) is always possible. Dissection of the part of the remnant lying across the anastomosis is obscured by the mesentery of the alimentary limb and must be performed, at the risk of devascularizing that part of the remnant, which is another reason why we do not hesitate to perform resection of its fundic part. 3.2. Banding the Pouch RYGB is commonly seen as a mixed procedure (mixed restrictive and malabsorptive). Even with a correctly constructed pouch and gastroenterostomy (GEA) the restrictive aspect may not suffice in some instances and may find benefit from additional measures. These measures include the placement of a non-adjustable band around the bypass pouch as reported by Fobi in open RYGB [18], and more recently by Bessler in laparoscopic procedures [19]). In our [20] (and in others‟) experience the secondary placement of a band is however fraught with a high erosion rate (in our experience up to 20%). Another, perhaps better option for addressing poor weight loss after RYGB consists of the placement of an adjustable band (AGB) around the gastric pouch as described by Bessler [21]. After banding the pouch with an AGB, further weight loss, varying from 55.9%–94.2% excess body mass index loss (EBMIL) has been documented after respectively 12–42 months of follow-up [22]. While theoretically the incidence of erosion after placement of an adjustable band should be lower than with a non-adjustable (Fobi) ring, adjustable band-specific complications such as slippage, infection and erosion of the band may appear. In case of one of the aforementioned mishaps it is better to remove the band (= foreign object), if at all possible by endoscopic technique, and to trim the pouch over a large bore tube. 3.3. Longitudinal Partial Resection of Pouch and Alimentary Limb (Gagner technique) Michel Gagner‟s team developed an interesting technique to influence the volumes involved in the bypass in an effort to resume weight loss without using a foreign object [23]. The technique consisted of reducing the gastric pouch together with the proximal part of the antimesenteric edge of the AL with a linear stapler. Long-term weight loss outcomes of this ingenious technique were however disappointing, both in Gagner‟s and in our 96 Jacques M. Himpens and Ramon Vilallonga experience. Rather than resecting the pouch and the AL longitudinally, we also attempted to reduce both by plication around a 34 Fr orogastric tube, quite similarly to the newly described technique that mimicks SG [24]. Unfortunately, here as well, midterm outcomes concerning weight loss were rather poor. 3.4. Endoscopic Trimming of Pouch and Gastro-Enteral Anastomosis Recently, several techniques have been described to reduce the size and/or the compliance of the gastric pouch and to reduce the size of the GEA. As previously mentioned, these techniques are beyond the scope of this chapter. 3.5. Reversal and Conversion to Sleeve Gastrectomy When all possible correctible causes for primary failure of the RYGB have been ruled out the multidisciplinary team may conclude that the choice for RYGB was not the correct one and may decide to reverse the bypass. See below (4.2) 4. Secondary Failure Secondary failure occurs when patients who initially experienced good weight loss and resolution of co-morbidities suffer a significant weight regain and resurgence of the comorbidities. This evolution indicates that the procedure most likely was indeed correctly chosen and well carried out (as demonstrated by the initial success), but that some unwanted evolution did interfere with continued weight loss. Causes of weight regain may well be patient related (diet, life style) or may be linked with anatomical changes that have developed over the years. There are conflicting data in the literature concerning the importance of the secondary dilation of the pouch, and of the dilation of the GEA [25, 26]. Based on the (poor) experience gathered with pouch trimming and anastomotic reshaping performed for primary failure, we cannot recommend a surgical re-intervention that limits itself to these objectives. In secondary failures the pouch can be banded (by adjustable or non-adjustable band) as well, but, as mentioned before, this strategy does carry its own complications. In addition, patients who got used to the quite comfortable eating conditions secondary to the RYGB more often than not will only reluctantly accept a new significant reduction. Reoperations for Roux-en-Y Gastric Bypass Failures 97 4.1. Distalization of RY Gastric Bypass The RYGB being a mixed restrictive-malabsorptive procedure, the malabsorption may be enhanced as well. Malabsorption can be augmented by increasing the length of the bypassed bowel. Consequently, the conventional “proximal” bypass may be converted into a “distal bypass.” Because of the substantial number of severe complications described in the literature, distalization of the bypass is only performed in well-compliant individuals who nevertheless developed weight regain after initial good weight loss. The best candidates are the patients who did not dilate their gastric pouch (hence cannot eat large volumes), but who developed a grazing (or polyphagic) eating pattern. Lengthening the AL to 200 or even 250 cm has proven useless on the long term for patients who failed the RYGB [27]. Conversely, “true” distal gastric bypass has been proposed several years ago as active remedial operation for failed RYGB. While extremely effective in terms of weight loss, the side effects of the distal construction however have proven too significant to allow general acceptance of the procedure. In the initial description by Sugerman, who used the distalization principle in patients who did poorly after (open) proximal bypass, the metabolic consequences were considerable and some patients died [28]. Brolin [29] found that only half of the patients had clear benefits from the conversion of a regular to a distal RYGB. However, Brolin described a particular type of distal bypass, with a very long alimentary channel and a very short (75 cm) common channel. Our technique of bypass distalization much more resembles the open operation described by Rawlins et al. [30], who reported good results in compliant patients with a construction of a 100 cm long CL and a 150 cm AL. We actually maintain a length of 150 cm both for the AL and the CL, the BPL not being routinely measured [31]. This technique has the practical advantage that mostly the alimentary limb had been constructed some 150 cm long, hence that all that needs to be done is to transect the alimentary flush with the entero-enteral anastomosis and to reimplant the alimentary limb on the common some 150 cm proximal to the ileocecal valve. Thus, the sum of AL + CL is approximately 300 cm, the minimum length to avoid protein malnutrition according to Scopinaro [14]. With our distalization strategy, besides inducing good additional weight loss in a good number of individuals, we managed to “cure” a patient from insulinodependent T2DM, despite a weight loss of approximately 50% EBMIL obtained by the “regular” RYGB. It is clear however that after distalization patients become at high risk to develop deficiencies including protein malnutrition, hence the obligation to select the patients in terms of compliance 98 Jacques M. Himpens and Ramon Vilallonga (as demonstrated by their behavior after the initial RYGB) and the commitment of both patient and multidisciplinary team to zealously follow-up the patient at regular intervals. 4.2. Reversal (Figure 3-11) and Conversion to Sleeve Gastrectomy (As First Step of a Duodenal Switch or DS) For some individuals the RYGB induces dietary restrictions -such as the interdiction of ingesting sugar- that proved too hard to keep. Non-compliance to the diet however results in an array of undesired symptoms including hypoglycemia and eventually weight regain. Figure 3. The gastro-enteral anastomosis must be taken down, uniting the gastric pouch (A) and the proximal part of the alimentary limb (AL) The gastro-enteral anastomosis is being transected (separation of A and B). Transection is performed just distal to the anastomosis to create ischemic discoloration of the most proximal part of the AL, which facilitates identification of the gastric pouch part at the anastomosis. Thanks to the ischemic discoloration of the most proximal part of the transected AL the trimming of the gastric pouch can be kept minimal. Reoperations for Roux-en-Y Gastric Bypass Failures 99 For these patients, the RYGB appears to represent a “wrong choice” on the long-term and it might consequently be better to change the metabolicsurgical strategy overall. Converting one procedure to another or even simple reversal of a procedure nowadays is less of a challenge than in the open surgery era, because laparoscopy causes far less adhesions. In order to allow more than one final choice it is an acceptable policy to initially reconvert the bypass anatomy to a normal situation. We described the technique in 2006 [32] and reported on our patients‟ outcomes a few years later [33]. Figure 4. A gastrotomy is performed in the remnant vis-à-vis the distal part of the pouch, that is opened in its distal part at this time. Obviously, reconversion to a normal anatomy will not likely improve weight loss. However, starting from the newly re-obtained normal anatomy, a LSG can be constructed, either immediately during the reversal or with some delay to give the patient the occasion to accommodate to the new situation [34]. A „„sleeve-like‟‟ gastrectomy can be performed over a 34-French bougie to calibrate the new stomach (Figure 10), while imbricating (“plicating”) the middle part of the sleeve proximal to the antrum of the stomach (Figure 11). 100 Jacques M. Himpens and Ramon Vilallonga Figure 5. Anastomosis is performed between the open pouch and the remnant (Posterior layer). A manual anastomosis is preferred. Please note that the vertical part of the pouch and the corresponding part of the remnant are not opened, but rather sutured together to restore a fundus-like structure to avoid reflux. Figure 6. Anastomosis is performed between the open pouch and the remnant (Anterior layer). A manual anastomosis is preferred. Please note that the vertical part of the pouch and the corresponding part of the remnant are not opened, but rather sutured together to restore a true fundus to avoid reflux. Reoperations for Roux-en-Y Gastric Bypass Failures 101 Figure 7. The JJ anastomosis is being transected at C, separating the BPL from the ALCL confluent. Note that first the original mesenteric defect must be recreated and that the linear stapler is placed slightly on the BPL side of the anastomosis to avoid narrowing at the AL-CL junction. A rim of ischemic tissue may thus be left on the ALCL side of the anastomosis, but this has no clinical significance. It appears that in some cases LSG is actually superior to RYGB, possibly because of the preservation of the antrum and pyloric sphincter, with subsequent enhanced gastric emptying [35] and inhibition of the orexogenic Ghrelin hormone [36]. In addition, in cases in which the restriction created by the sleeve does not suffice, the “natural complement” of the LSG, i.e., a DS may be carried out. DS is a typical biliopancreatic diversion, and has been shown to be the most active procedure in terms of T2DM remission rates [37]. In addition, because of the preservation of an acceptable stomach volume (i.e., the sleeved stomach), unlike with the distal gastric bypass, the DS might be safer than the distal RYGB. 102 Jacques M. Himpens and Ramon Vilallonga Figures 8 and 9. Anastomosis between B (previously the proximal AL) and C (previously the BPL), restoring the continuity of the small bowel. Care must be taken not to twist the mesenteries of the 2 small bowel loops. With the technique usually chosen for RYGB the mesenteric defect at this anastomosis should be quite small. Reoperations for Roux-en-Y Gastric Bypass Failures 103 Figure 10. A „„sleeve-like‟‟ gastrectomy can be performed by the use of a 34-French bougie to calibrate the new stomach.. The technique starts by devascularizing and resecting the fundus, ending a few cm proximal to the level of the newly fashioned anastomosis. Figure 11. Plication of the middle part of the sleeve proximal to the antrum of the stomach. 104 Jacques M. Himpens and Ramon Vilallonga 5. Revisional Procedures After RYGB for Complications Interfering with the Outcome 5.1. Hiatal Hernia and Gastro-Esophageal Reflux (GERD) Despite the recognized efficacy of the RYGB anatomy in abolishing GERD, reflux symptoms may complicate even RYGB. Usually, reflux will be alkaline, but acid reflux is possible as well, perhaps as a result of too large a gastric pouch or too a short an AL, or, more frequently, as a result of an abnormal communication between the bypassed gut and the pouch or the AL as seen in gastrogastric fistula. Alternatively, an obstruction may be causing acid reflux, as in cases with severe adhesions impacting on the CL or in trocar orifice herniation. In case of alkaline reflux, a Hiatal Hernia (HH) must be ruled out. HH can be highly symptomatic after RYGB, not only in terms of GERD, but in terms of dysphagia as well. The latter condition may induce excessive weight loss, which may warrant reintervention. Rarely, HH involves herniation of the excluded stomach, a situation that requires immediate reoperation because of the risk of strangulation. Figure 12. Our personal technique of crural repair. While the fully dissected distal esophagus (ESO) is reclined anteriorly, the posterior closure of the hiatal crura is performed by at least one Figure of 8 stitch of polypropylene material buttressed by cellulose acetate pledgets. Reoperations for Roux-en-Y Gastric Bypass Failures 105 When performing hiatal exploration a thorough circular exploration of the crura must be performed as well as dissection/liberation of the distal esophagus, the latter being important to rule out epiphrenic diverticula and to provide sufficient slack for the intra-abdominal esophagus, an essential condition in avoiding recurrence [38]. In our experience, crural repair is best performed by posterior placement of non-absorbable, deep stitches, that are then tied over pledgets (we usually use cellulose acetate pledgets) [39] (Figure 12). The use of prosthetic mesh is best avoided because of the risk of erosion in a previously dissected area. 5.2. Issues at the Gastro-Enteral Anastomosis A dreaded problem at the GEA is the anastomotic or marginal ulcer, a condition that occurs in up to 50% of the cases [40]. Causative factors include excessive acid production as with a large pouch (but again, a gastrogastric fistula must be ruled out), ischemia, and the persistence of foreign material (staples or non-absorbable sutures). Marginal ulceration appears more frequently in smokers. When conservative management including the use of large doses of proton pump inhibitors (PPI) fails, surgical treatment may be considered. In case of perforation, surgical treatment must be performed immediately. 5.2.1. Elective Treatment of Marginal Ulceration The first treatment of chronic marginal ulcer is the cessation of cigarette smoking. Smoking is a leading cause of recurrent anastomotic ulceration. Surgical exploration should aim at reducing the acid production, e.g., by reducing the size of the pouch, by performing vagotomy, or, more radically, by performing remnant gastrectomy to permanently reduce gastrin and subsequent acid production. Even in the presence of small pouches, in case of chronic marginal ulcer, we usually resect the GEA together with a chunk of pouch, care being taken not to induce ischemia. To avoid vascularity issues, dissection at the lesser curve is kept minimal and transection (either stapled or preferably manual, with the coagulating hook) performed at an angle, keeping the greater curvature part of the pouch substantially shorter than the lesser curvature. Reanastomosis is preferably performed manually to avoid ulcer-inducing staples. We usually perform resection of the fundus as well, with the purpose to allow better visualization of the greater curvature side of the pouch, and to reduce systemic acid production overall. 106 Jacques M. Himpens and Ramon Vilallonga 5.2.2. Emergency Treatment of Marginal Ulceration When faced with perforated anastomotic ulceration, the surgical treatment should be confined to dealing with the acute situation, i.e., the perforation itself. Trimming of the edges of the ulcer and suture closure covered by an omental patch is probably the best initial treatment. Because of the invariably present concomitant peritonitis, it is preferable to delay more extensive treatment such as described in 5.2.1. (the search for a gastro-gastric fistula, trimming of the pouch and total reconstruction of the GEA ) to a later date, when septic symptoms and acute inflammatory changes have subsided. In exceptional cases the perforation involves the remnant part and a bulbar ulcer may be found. Treatment should be as for any perforated duodenal ulcer. 5.3. Other Circumstances Amenable to Surgical Correction 5.3.1. Blind Loop Syndrome (Candy Cane Deformation at the GEA, “cloaca” Formation at the JJ Anastomosis) Not infrequently patients who underwent LRYGB several months to years previously complain of abdominal pain confined to the left upper quadrant together with severe nausea and sometimes dysphagia. This condition is pathognomonic for blind loop syndrome. Diagnosis can be made by barium swallow (to identify a “candy cane” deformation of the blind end of the AL) and/or by CT scan (to diagnose a “cloaca” formation at the level of the Y anastomosis). Treatment is surgical (laparoscopic) and consists of stapled resection of the redundant part (Figure 13). Care must be taken to avoid excessive narrowing of the lumen, which especially at the GEA may result in increased dysphagia. Stenosis may cause staple line leakage as well. 5.3.2. Intussusception at the JJ Anastomosis An unusual cause of obstruction is the intussusception at the level of the JJ anastomosis. Mostly the condition consists of the retrograde invagination of the CL into itself and into the JJ anastomosis [41]. The cause is unclear, but one hypothesis is the existence of an active pacemaker in the distal small bowel that sends impulses in a retrograde fashion. Typically these patients will present a typical “target sign” at the abdominal CT scan. Reoperations for Roux-en-Y Gastric Bypass Failures 107 Figure 13. The candy cane deformity of the blind end at the alimentary limb may become highly symptomatic and demand resection. It is important to pull the uppermost part of the “candy cane” cephalad and to the left rather than to pull on the staple line. Note the presence of a large bore orogastric tube to prevent stenosis. Treatment is surgical (laparoscopic) and quite urgent to avoid necrosis. The best approach consists of plication, or, better, resection and redo of the JJ anastomosis, because simple reduction and fixation is fraught with a high incidence of recurrences. 5.3.3. Internal Hernia Internal hernia (IH) is a common cause of chronic pain after RYGB. Typically the patient suffers crampoid pain, comparable to contraction pains 108 Jacques M. Himpens and Ramon Vilallonga during labour, most often occurring after a meal. Some patients become emaciated because of this condition. It is noteworthy that previous closure of the mesenteric and Petersen defect (Figure 2) does not provide fool-proof warranty for absence of IH. In a recent retrospective study performed 9 years after the LRYGB [42], we found that the incidence of small bowel occlusion including IH was a frightening 9%, despite our policy of systematically closing all the defects with nonabsorbable suture. Obviously, technical flaws may be responsible for this finding, but it is possible as well that the sometimes massive weight loss creates gaps in an initially well performed closure. Diagnosis in the acute setting is merely clinical: a patient with excruciating pain should be taken to the operating room for emergency laparoscopic exploration. When the cause of the acute abdomen is indeed found to be an IH, some bowel loops will appear dusky (or black!). Often a substantial quantity of intraperitoneal milkywhite fluid may be noted, corresponding to chyle, produced by the chronic hyperpressure in the lymphatics of the small bowel. When reduction of an IH is attempted it is wise to start exploration at the ileo-cecal transition and to gently pull the bowel, passing it from the grasper in one hand to the other, going cephalad, until a “snap” is felt which indicates the reduction of the herniated part. Closure of the defect that caused the IH is usually straightforward after adequate reduction and should be performed by a running suture of non-resorbable suture material. 5.3.4. Excessive Weight Loss and Protein Malnutrition This condition is quite rare after “regular” RYGB. However, malnutrition is occasionally encountered in some patients who skipped the scheduled follow-up visits, neglected their complaints (of nausea, e.g.) or developed extremely poor eating habits consisting of exclusively ingesting carbohydrates for example. These patients may lose excessive weight and/or develop hypoproteinemia. These individuals invariably present a significantly impaired healing capacity because of malnourishment and are therefore initially best treated by the laparoscopic placement of gastrostomy in the excluded stomach (food stuffs administered via this route will be fully absorbed). After recovery of their metabolic balance these patients will require extensive counseling to address their poor dietary habits, and sometimes will need to undergo corrective surgery which may consist of reversal of their procedure. Reoperations for Roux-en-Y Gastric Bypass Failures 109 5.3.5. Hypoglycemia and Neuroglycopenia The dramatic impact of RYGB on glucose metabolism, even in the absence of T2DM is well documented. Recently, some attention has been paid to the hypoglycemia syndrome, a condition appearing some 2 to 3 years after the RYGB procedure and characterized by the apparition of hypoglycemia some 90 minutes to 2 hours after a meal (especially after a meal rich in carbohydrates). Hypoglycemia may be accompanied by vague symptoms of light-headedness, fatigue, exhaustion and marked tremor, but syncopes and epileptic insults are relatively common as well. When neurological symptoms of hypoglycemia become apparent, the syndrome is referred to as neuroglycopenia. This clinical condition is remarkably underestimated and is often confused with “chronic fatigue,” fibromyalgia, or organic central neurological aberrations. 5.3.4.1. Diagnosis The diagnosis of the hypoglycemia syndrome is essential because this condition may cause car accidents, accidents on the work floor, or in the household. The clinical aspect differs from the dumping syndrome because individuals suffering from hypoglycemia very rarely mention pain and/or diarrhea. Also, the chronology of events differs, the symptoms with the hypoglycemia syndrome occurring later after a meal than with dumping. Initial diagnosis can be made by a tolerance test with a standard meal or with oral glucose. It is important to record the clinical symptoms that go together with the biochemical hypoglycemia during the test, because some patients do not suffer any symptoms despite plasma glucose values as low as 30 mg/dl. Once the diagnosis of hypoglycemia, which is secondary to an exaggerated insulin response to carbohydrates and sugars, has been made [43], the possibility of an insulin producing pancreatic tumor must be ruled out. The most accurate test available is the sampling of plasma insulin after selective intra-arterial peripancreatic Calcium injections. Intra-arterial Calcium elicits a pancreatic insulin response when a secreting tumor is present. The selectivity of the test allows to detect the approximate location of the tumor in the pancreas. Additional diagnostic tools are the Magnetic Resonance Scan and the Octreotide inhibition test. 5.3.4.2. Treatment The first treatment of the hypoglycemia syndrome is dietary: patients should refrain from all intake of simple sugars and limit the ingestion of carbohydrates. The requested change in eating behavior is a considerable task, 110 Jacques M. Himpens and Ramon Vilallonga because most patients go through an acute withdrawal phase when kept away from carbohydrates and sugars. Medical treatment consists of oral acarbose, diazoxide or parenteral octreotide but these treatment modes are expensive and not very efficient [44] Surgical treatment The most effective treatment is surgery. Three types of operations have been described: the placement of a band or ring around the pouch to slow down gastric emptying pancreatectomy. reversal of the procedure 1/ Placement of band around the stomach pouch This treatment was proposed more specifically to address the problem of postprandial dumping [45]. Despite quite good outcomes in terms of dumping reduction, this technique faces the relatively high incidence of complications we already mentioned. Moreover, the technique does not appear to be effective in true postprandial hypoglycemia. 2/ Pancreatectomy Theoretically, pancreatectomy makes sense because it removes the source of insulin secretion. This strategy was first described by Service et al. [46]. Despite good short-term outcomes this very aggressive surgical procedure however does not appear to keep its promises on the long term. 3/Reversal (as mentioned before) Reversal of the bypass construction is logical because it addresses the alleged cause of insulin hypersecretion, i.e., the bypass of the duodenum, causing an imbalance in incretin production. Some reports however question this approach [47]. There is quite a simple strategy to avoid reversing a bypass for hypoglycemia syndrome in vain. This strategy consists of placing a gastrostomy tube in the remnant stomach, either laparoscopically, or percutaneously, under CT guidance. The patient hereafter is fed exclusively through the gastrostomy. When hypoglycemia clearly regresses (which can be documented by an oral tolerance test through the gastrostomy tube), reversal Reoperations for Roux-en-Y Gastric Bypass Failures 111 may safely be attempted. We try to perform full reversal rather than a functional reversal, which may be obtained by gastro-gastrostomy uniting pouch and remnant. Rather, we perform transection of the GEA and of the JJ anastomosis at the level of the BPL ending. The blind end of the AL and of the BPL are reanastomosed, hereby restoring small bowel continuity. Finally, the pouch and remnant are reanastomosed as well, which concludes reversal to a normal anatomy (and may be complemented by sleeve-like gastrectomy) (Figures 3-11). CONCLUSION The laparoscopic Roux-en-Y gastric bypass has passed the test of time and a number of patients have now undergone the procedure more than 10 years ago. Even though the overall outcomes are excellent, not unexpectedly, some late complications do arise, creating weight problems or other conditions that may be significant in terms of patient comfort and even safety. This chapter attempted at describing the most common problematic issues occurring occasionally after (laparoscopic) Roux-en-Y gastric bypass and to come up with an acceptable strategic approach (Figure 14). Figure 14. Algorithm showing the surgical management for Roux-en-Y gastric bypass failures. 112 Jacques M. Himpens and Ramon Vilallonga REFERENCES [1] Scozzari G, Toppino M, Famiglietti F, Bonnet G, Morino M. 10-year follow-up of laparoscopic vertical banded gastroplasty: good results in selected patients. Ann Surg. 2010;252(5):831-9. [2] Mason EE, Ito C. Gastric bypass in obesity. Surg Clin North Am 1967;47(6):1345-51 Kuzmak, L.I., A Review of Seven Years' Experience with Silicone Gastric Banding. Obes Surg.1991;1(4): p. 403-408. 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In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 7 FAILED MINIGASTRIC BYPASS: SURGICAL STRATEGIES Jean-Marc Chevallier Department of Bariatric Surgery, Hôpital Européen Georges Pompidou, Paris, France ABSTRACT Against morbid obesity MGB is an alternative to RYGB with less morbidity and same long-term efficiency because it involves just one anastomosis. But the presence of bile in the afferent limb and the 200 cm long bypass imply that MGB failure reoperations must be approached differently than after RYGB. Revision rate is between 0.8 and 4.7% in the literature, 2% in our experience (20/1000). Revisions are performed for complication (leaks, biliary reflux or marginal ulcer), inadequate weight loss or malnutrition. Leaks after MGB can lead to biliary peritonitis and must be treated quickly by conversion from MGB to RYGB. Intractable bile reflux is rare (0.9%) and must be treated by conversion of the MGB to RYGB, provided the common limb length down to the ileocecal valve is longer than three meters. Insufficient weight loss or weight regain (4.9%) require a multidisciplinary assessment to evaluate eating disorders and to appreciate if there is a true pouch dilatation. If the patient remains morbidly obese and the gastric pouch appears dilated a revision with Corresponding author: Professor Jean-Marc Chevallier. Department of Bariatric Surgery, Hôpital Européen Georges Pompidou, 20 rue Leblanc, 75015 Paris, France. E-mail: [email protected]. 118 Jean-Marc Chevallier pouch trimming might be efficient. If the pouch is not dilated a band can be placed around the gastric tube in order to add more restriction. MGB is more malabsorptive than RYGB but the rate of malnutrition appears low (between 0.3 and 1.28% in the literature). In case of alarming malnutrition a revision can be decided after preparation. Restoration of a normal anatomy can easily be performed after MGB. The conversion of the MGB to a sleeve gastrectomy has a substantial leakage rate but it obviously allows the patient to keep thin. With experience MGB appears to have a small reoperation rate, to be easily converted or reversible if necessary. It should thus be considered in the armamentarium of bariatric surgeons. INTRODUCTION Morbid obesity has become a public health problem in most countries. It leads to a high incidence of complications that decrease life expectancy, even in young adults. Medical treatment of obesity is known to bring disappointing results; however, bariatric surgery has been proved to be efficient for the treatment of morbid obesity, and for decreasing even mortality and complication rates [1]. Our surgical team has 20 years of experience in laparoscopic bariatric surgery. We used to perform the Laparoscopic Roux-en-Y gastric bypass (RYGB) using the Lonröth technique, which consists of an omega loop raised up to the gastric pouch, in which both anastomoses are created and then separated by a section converting the omega into a Roux-en Y gastric bypass [2]. The Laparoscopic Minigastric Bypass or One Anastomosis Gastric bypass (MGB) is a modification of this omega loop bypass, with only one anastomosis, namely the gastrojejunostomy. In 2005, a prospective randomized trial compared MGB to RYGB and showed better outcomes for MGB at 2 years [3]. However MGB has raised criticism and controversy, especially regarding its potential risk of biliary reflux [4]. More recently, some long-term series on MGB have shown promising results in terms of security and efficiency [5-9]. After having published the outcomes of our first 100 MGB procedures [10], we have recently reported on our first 1000 MGB procedures over a 7year period [11]. We compared these results to the literature and focused in this chapter on surgical strategies in case of MGB failure. Failed Minigastric Bypass: Surgical Strategies 119 1. THE MGB PROCEDURE (FIGURE 1-2) All surgical procedures were carried out by six different surgeons using the same standardized technique (Figure 1). Details of the surgical procedure have been published previously [10], and are similar to those described by Rutledge [12]. A long and narrow gastric tube was created by applying one horizontal 45-mm roticulator Endo-GIA® stapler (Covidien, Cincinnati, OH, US) at the angle of lesser curvature, just above the left branch of the crow‟s foot, and then four to five vertical 60-mm roticulator Endo-GIA® staple cartridges upward to the angle of His, calibrated along a 32-Fr bougie, similar to the vertical part of a sleeve gastrectomy. No reinforcement was done on the staple line. Section of the greater omentum in bivalve was performed. The jejunum was mounted antecolically at 200 cm down from the ligament of Treitz, and a side-to-end anastomosis (Figure 2) was performed with the gastric tube using a posterior 45-mm Endo-GIA® stapler and an anterior running suture. A nasogastric tube was passed into the efferent loop, and a closed vacuum drain was placed behind the anastomosis. The anastomosis was finally checked using an intraoperative methylene blue test. Figure 1. One anastomosis Gastric Bypass. 120 Jean-Marc Chevallier Figure 2. Linear stapled gastrojejunal anastomosis. 2. DEFINITION OF FAILURE; REVISION OF AN MGB In most series weight loss was determined as changes in mean BMI and mean percent Excess Body-Mass Index loss (%EBMIL), with BMI 25 as the upper limit of normal according to the actually adopted standard measure [13]. Failure can be due to complication (marginal ulcer or intractable bile reflux), insufficient weight loss (defined by a %EBMIL of < 25%) or on the opposite, excessive weight loss with malnutrition (%EBMIL > 100% with albuminemia < 30 g/L). Table 1 summarizes late revisions after MGB in four long-term studies. Revision rate was between 0,8 and 4.7%. Lee published in 2011 a revision rate of 1.7% on 1322 MGB at 9 years follow up [14]; these data have been updated in 2012 in comparison to RYGB [7]. 121 Failed Minigastric Bypass: Surgical Strategies Table 1. Late revisions after MGB in the literature Lee 2012 [14] Musella [8] Inadequate WL Bile reflux malnutrition Obstruction Internal hernia Marginal ulcer stricture 10 (0.9%) 4 (0.3%) 10 (0.9%) 1 0 7 1 1 TOTAL 33/1322 (2.8%) 1 1 0 4 0 7/818 (0.8%) Noun [6] 4 4 33 (open) 0 6 0 47/1000 (4.7%) Chevallier [11] 4 7 2 5 0 2 0 20/1000 (2%) WL = weight loss. In this latter paper the two most common reasons for revision were malnutrition and inadequate weight loss in 10 (30,3%), marginal ulcer in 7 (21,2%) and intractable bile reflux in 4 (12,1%) patients. Revisional surgery performed was RYGB in 11 (47.8%), Sleeve Gastrectomy in 10 (43.5%) and conversion to a normal anatomy in 2 (8.6%) patients. In our recently published experience [11] we had to revise 20 patients (2%): 7 for intractable reflux (35%), 5 for intestinal obstruction, 4 for inadequate weight loss, 2 for marginal ulcer, and 2 for malnutrition. The chapter will be divided in three parts: revision for complication, inadequate weight loss and malnutrition. 3. REVISION FOR COMPLICATION The early complication rate was 6% in the meta analysis [15], 51 leaks (1%), 2.8% marginal ulcers, 4.2% anemia. Late complications leading to revision are collected in Table 1. 3.1. Leaks Our 0.6% rate of leakage is low, and is similar to other series [5-9]: this may be because a good blood supply was preserved in the thinner gastric tube and jejunal loop without mesenteric interruption. 122 Jean-Marc Chevallier After MGB leak at the gastrojejunostomy leads to a biliary peritonitis. As for every bariatric procedure in case of leakage the reoperation must be decided as soon as possible, but in the case of MGB it is even more important because of the presence of bile. If the reoperation has been decided soon enough the treatment of the leak can actually be a simple suture, but it has to be accompanied by the conversion of the MGB to a RYGB in order to move the bile away from the gastrojejunostomy (see below). 3.2. Biliary Reflux Critics of the MGB procedure compare it to the first bypasses performed by Mason in 1969 [16], which consisted of horizontal sectioning of the proximal part of the stomach and then raising the bowel loop to form an omega shape. The proximity of the anastomosis to the esophagus caused incapacitating biliary reflux, which led the author to abandon the omega procedure for the Roux-en-Y procedure. Symptomatic biliary reflux is not frequent after MGB and most of the time can be cured medically. In a recent publication [17] we compared postoperative GIQLI (GastroIntestinal Quality of Life Index) 5 years after MGB with preoperative GIQLI. Interestingly we found no significant differences in the GERD symptoms (Regurgitation, heartburn, nausea, belching) between the two groups. Lee reported intractable bile reflux in four cases [7]. In our experience 11 cases of biliary reflux so far necessitated us to convert to a RYGB at ~2 years post-MGB in patients who had lost all their excess weight. The conversion had a spectacular effect on biliary reflux, and patients also maintained their weight loss. However, GERD is rarely a problem in MGB because the anastomosis is placed low in the stomach. Although it is common to find bile around the anastomosis in the medium- and long-term, it is rarely seen as far up as the esophagus. MGB actually creates an anatomy where reflux is intuitively promoted, as opposed to the standard RYGB. This is one of the major criticisms raised against the MGB: unfortunately, our data were insufficient to determine if this criticism is unfounded. We can only mention that among the post-operative gastroscopic biopsies conducted, we found foveolar hyperplasia, a sign of biliary reflux, in only 13/76 (17.1%) cases at 2 years and in 2/43 (4.6%) cases at 4 years, with no dysplasia or metaplasia [18]. We have no experience of the anti-reflux technique, as described by others [19]. In our technique the gastric pouch must be long and narrow. Stapling Failed Minigastric Bypass: Surgical Strategies 123 must be vertical, perpendicular to the incision in the pouch, and above the posterior surface of the stomach so that the afferent loop comes from the back, and is higher than the efferent loop. If biliary reflux ever becomes intractable, conversion to RYGB is still a valid and effective straightforward option. 3.3. Marginal Ulcer One of the classic concerns with a gastrojejunal bypass is the occurrence of marginal ulcers at the edge of the gastrojejunal anastomosis, a condition that is caused by the small gastric pouch continuing to secrete acid. In a recent meta-analysis collecting 5095 cases operated between 1997 and 2011 in seven different centers [15] the marginal ulcer rate was 2.8%. Most of the marginal ulcers appear to be curable medically. In our experience two ulcers were revealed by symptoms of peritonitis late in follow-up. Both patients were heavy smokers; they had lost all their excess weight, and had stopped taking proton-pump inhibitors. Overall, the number of marginal ulcers (2%) was however low and equivalent to that found after RYGB [20]. The rate of ulcers was probably low because of our policy of preoperatively screening for Helicobacter Pylori and eradicating whenever present. The small size of gastric pouches with our technique, and the routine prescription of proton-pump inhibitors most likely helped keeping the incidence as low as well. A larger gastric pouch in MGB (likely producing more acid) might increase the incidence of ulcers; a pouch must be long and narrow to keep the acid secreting volume low. The bile in contact with the anastomosis may actually buffer the ulcerogenic effect of acid on the anastomosis [21]. As for RYGB smoking was a risk factor for marginal ulcers throughout this series We think that patients who continue smoking after an omega-loop bypass need to keep taking proton-pump inhibitors. 3.4. Conversion of MGB to RYGB (Figure 3) In case of leak or intractable bile reflux MGB can be converted to RYGB. Two techniques are available to convert MGB to RYGB: 3.4.1. to perform a latero-lateral jejunojejunostomy 70 cm distal to the gastrojejunostomy (Figure 3 A) 124 Jean-Marc Chevallier to staple the afferent loop just between both anastomosis (Figure 3B) to close the mesenteric defect (Figure 3C) This technique was proposed by Lee [14] but might be dangerous: because the bypass is already 200 cm long, adding 70 cm results in a 270 cm, which could be too long and lead to malnutrition (see below). The best approach is to measure the total limb length down from the gastrojejunostomy. If it is more than 3 meters long, Lee‟s technique may be performed with security. If limb length is less, the following second option should be used. 3.4.2. Resection of the anastomosis restoration of the digestive tract by a linear side-to-side enteroenterostomy then performing a regular RYGB by transecting the gastric pouch more proximally and constructing a 1.5-meter long alimentary limb (Figure 4). Figure 3. Conversion MGB to RYGB: easy way (1: jejunojejunostomy, 2: section between both anastomosis). Failed Minigastric Bypass: Surgical Strategies Figure 3A. Jejuno-jejunostomy (70 cm distal from Gastrojejunal anastomosis). Figure 3B. Section between both anastomosis. Figure 3C. Closure of mesenteric defect. 125 126 Jean-Marc Chevallier Figure 4. Conversion MGB to RYGB: regular RYGB. 1: resection of GJ anastomosis. 2: enteroenterostomy. 3: regular RYGB. 4. REVISION FOR INADEQUATE WEIGHT-LOSS Five percent (n = 49) of patients had a ≤ 25% EBMIL and had to be considered weight-loss failures [11]. In this population, the mean preoperative BMI was 42.5 ± 6.4 kg/m2 and the %EBMIL was 13.8 ± 12.6% at 5 years. Noteworthy, 40% of these patients previously had had a gastric banding (LAGB). Dilatation of the gastric pouch occurred in four patients, which caused excessive weight regain by 24 months post MGB. The dilatation was assessed by an upper GI series. Redo surgery was done by pouch trimming using a calibration tube for all patients, at ~4 years post MGB, when patients had a mean BMI of 39.3 kg/m2 and a mean %EBMIL of 40.3%. There was no peror post-operative morbidity. Failed Minigastric Bypass: Surgical Strategies 127 At 5 years, these patients' mean BMI was 35.9 kg/m2 and %EBMIL was 55.7%. Three of these four patients had had LAGB before MGB. In front of inadequate weight loss the first question is: is it primary weight loss or weight regain? A psychological and dietetical assessment is mandatory. The multidisciplinary team has to be consulted for an unanimous decision before considering reoperation. The discussion about weight regain after MGB is not very different from the one after RYGB. Revisional procedures can be either endoscopic or laparoscopic. Considering the potential risk of redo surgery, an endoscopic procedure should be the first choice to improve weight loss. Unfortunately these advanced endoscopic procedures are still under evaluation and not significantly efficient so far [22]. Consequently most of the cases actually are treated by redo surgery. The choice of the type of surgery should be guided by different factors to limit complications. It has actually been proven that the risk of leakage is more important after redo surgery than after the primary bypass [23]. The local anatomical conditions might influence the decision: previously dissected tissues, sclerosis caused by postoperative leakage can lead the surgeon to avoid stapling or resection. Diabetes resurgence may invite for a more malabsorptive radical solution, such as a distal bypass or a duodenal switch. Conversely, patients who regain weight after initial good weight loss have, most of the time, lost the restrictive part of the bypass. A regular upper GI series or a 3-D CT-scan volumetry will then assess a pouch dilatation. A pouch over 200 cm3 is considered the threshold to reoperate [24]. Two options are available: pouch trimming or banding. 4.1. Pouch Trimming After MGB Failure (Figure 5) The restrictive action of MGB is due to a long and narrow gastric pouch, which recently has been considered as the most efficient form of pouch even in RYGB [25]. As with RYGB, pouch trimming may be considered when there is an actual pouch dilatation. If pouch dilatation was due to a technical mishap in the previous operation (incomplete section of the upper fundus too far away from the EG junction) (primary dilatation) trimming the pouch is worthwhile. If dilatation occurred after the operation (secondary dilatation), because of inadequate eating behavior the decision to reoperate is highly dependent on the psycho-dietetical evaluation. 128 Jean-Marc Chevallier Figure 5. Pouch trimming for weight regain. Outcomes of reoperation have been reported as good with a primary dilatation, but moderately good after a secondary dilatation. Reoperation begins by complete adhesiolysis with clear identification of the anastomosis, the biliary and alimentary limbs. The gastric pouch must be dissected off the remnant stomach with freeing of all adhesions of the greater omentum. This usually allows to appreciate the magnitude of the pouch dilatation. The gastric tube has then to be separated from the excluded stomach and the omentum up to the left diaphragmatic crus. This exposes the pouch that can now be resected upwards by a linear Stapler exactly like a "re-sleeve." As in every redo gastric resection it could be advisable to use higher staples (especially in the higher fundus) and/or reinforcement material. A methylene blue test can also be performed to check the staple line. 4.2. To Band a MGB (Figure 6) If a bypass failure is due to a failure of the restrictive part it is also possible to add some restriction by putting a band around the gastric pouch. This has been reported for RYGB failures and led also Mal Fobi to propose a non-adjustable banded bypass, which led to prolonged weight loss [26]. Some series have shown that putting an adjustable band around the gastric pouch after a RYGB can lead to better weight loss afterwards [27]. Even though this has not been published yet it seems particularly suitable to put a band around the tube of a MGB because this tube is long and even in case of Failed Minigastric Bypass: Surgical Strategies 129 dilated tube there is always room enough to put the band around the stomach above the anastomosis. The technique is exactly the same as putting a primary band through the pars flaccida. After having opened the pars flaccid of the little omentum, the peritoneal sheet is cut along the edge of the right crus and a retrogastric tunnel is dissected. The posterior dissection reaches the left crus and the band is placed at the upper part of the gastric tube far away from the anastomosis. As there is no longer a lesser sac, the band is not fixed posteriorly. It is then advisable to fix the band to the excluded stomach by three stitches: one above and two beneath the band. 5. REVISION FOR MALNUTRITION Excessive weight loss can be considered as %EBMIL > 100% and albuminemia < 30 g/l. Rutledge observed malnutrition in 31/2401 patients [12], Noun in 4/1000 [6] and Lee in 9/1322 [14]. Figure 6. Band on MGB. 130 Jean-Marc Chevallier In our experience malnutrition occurred in three patients [11]. Their mean BMI at 5 years was 19 kg/m2 and %EBMIL was 124% and 122%. After treatment in a specialized medical unit with parenteral alimentation and psychiatric support, they recently had a reversion of the SAGB into a normal anatomy. The potential risk of malnutrition after MGB occurs because of the long bypassed biliary limb, with consequences depending on the length of the common limb. 5.1. Considerations on “Normal” Limb Length The "normal" efferent limb length is 592 cm (extremes: 380-790). This means that the length of the intestine can be very variable [28]. It is usually considered that an effective and safe bypass must bypass 1/3 of the total limb length. The regular MGB bypasses 200 cm. This is adapted if the total limb length is 600 cm. If the efferent limb is only 380 cm long (lowest extreme), this means that the remaining common limb will only be 180 cm long (less than 50% of the efferent limb) which could lead to protein deficiency or malnutrition. If the limb is 790 cm long (highest limit), the bypass will be around ¼, which could be not enough and may lead to insufficient weight loss. These considerations highlight the fact that it is important, when performing a malabsorptive procedure like MGB, to measure the whole intestinal length from the ileocaecal valve upwards or at least to check that there are still three more meters down from the anastomosis. This also explains why a regular RYGB (which bypasses 150 cm) can lead to failure if the total limb length is 790 cm. All theses considerations do not take into account the villi‟s surface for each cm2 that could be different from one patient to another and decreases with age. 5.2. MGB 'S Risk of Malnutrition Too short a common limb can lead to protein deficiency and malnutrition whatever the patient eats. One of the criticisms about MGB is that patients may complain of frequent stools, bowel urgency or diarrhea. Lee [7] reported that, when compared with RYGB, MGB patients had a similar QOL at five years and experienced less abdominal pain but higher stool frequency. Failed Minigastric Bypass: Surgical Strategies 131 In our experience [17], patients usually have 3 to 4 stools per day during the first 3 months after MGB, and then the rhythm slows down to one or 2 unless when patients continue to consume fats. We compared postoperative GIQLI five years after MGB with preoperative GIQLI. Interestingly, as demonstrated by Lee, we found no significant differences in diarrhea symptoms between the preoperative and the 5-year's groups. According to the literature the rate of malnutrition after MGB could be between 0.3 and 1.3% (Table 2). 5.3. When to Reoperate? After a period of incapacitating diarrhea, the albuminemia level falls under 30 g/L. It is important to check the serum prealbumin, showing the lack of protein pooling. The patient has to be hospitalized in a medical unit to check the whole gut and use parenteral nutrition. Most of the time this period of parenteral nutrition improves the nutritional status but when the patient comes back home there may be further deterioration. The recurrence of protein deficiency is an indication to reoperate, especially because parenteral feeding often leads to venous catheter infection. 5.4. Which Revision? In case of malnutrition after MGB the patient's situation becomes dangerous. The debate is whether it is better to restore the normal anatomy (exposing the patient to return to morbid obesity) or if it is possible to let a secure part of a bariatric procedure (convert the MGB to a Sleeve gastrectomy). 5.4.1. Restoration to a Normal Anatomy (Figure 7) The MGB can be considered as easily reversible. The restoration of a normal anatomy can be performed by the following consecutive steps: 1. Section of the stomach above the anastomosis (Figure 7 A) 2. Creation of a vertical gastro-gastrostomy (Figure 7B) 3. Restoration of the digestive tract by a linear enteroenterostomy (Figure 7C) 4. Resection of the anastomosis (Figure 7D) 132 Jean-Marc Chevallier Table 2. risk of malnutrition after MGB according to literature N % Rutledge [12] 31/2401 1.28% Noun [6] 4/1000 0,4% Lee [7] 9/1322 0.6% Chevallier [11] 3/1000 0.3% Figure 7. Restoration of a normal anatomy. (1: section above the gastrjejunostomy, 2: gastrogastric anastomosis, 3: jejunojejunostomy, 4: resection of GJ anastomosis) Figure 7A. Section above the gastrojejunostomy. Failed Minigastric Bypass: Surgical Strategies Figure 7B. Gastrogastric anastomosis. Figure 7C. Jejuno-jejunostomy. Figure 7D. Resection of gastrojejunal anastomosis. 133 134 Jean-Marc Chevallier 5.4.2. Conversion of a MGB to a Sleeve Gastrectomy This conversion has been described by Himpens et al., for a RYGB [29]. The difference is that with RYGB a handsewn gastrogastric anastomosis must be performed between the pouch and the part of the stomach just distal to the horizontal stapling line. This leaves a stomach volume that can be resected at the end of the procedure aided by the use of a 32 or 32-Fch bougie to calibrate the new stomach. CONCLUSION MGB is an alternative to RYGB with less morbidity and same long-term efficiency because it involves only one anastomosis. Nevertheless, the presence of bile in the afferent limb and the 200 cm long bypass imply that MGB failure reoperations must be discussed somehow differently than after RYGB. Leaks can lead to biliary peritonitis and must be treated by conversion from MGB to RYGB. Intractable bile reflux is rare and must be treated by conversion of the MGB to RYGB, but the common limb length must be longer than 3 meters down to the ileocecal valve. Insufficient weight loss or weight regain may happen. A multidisciplinary assessment must be evaluated if there is pouch dilatation. If the patient remains morbidly obese and the gastric pouch appears dilated, a revision with pouch trimming might be efficient. If the pouch is not dilated, a band can be placed around the gastric tube to add more restriction. MGB is more malabsorptive than RYGB, but the risk of malnutrition is less than 4%. If the patient is at danger, a revision can be decided after preparation. Restoration of a normal anatomy can easily be performed after MGB. The conversion of the MGB to a sleeve gastrectomy allows the patient to keep thin but has a higher leakage rate. See algorithm Figure 8. With experience, MGB actually appears to have a small reoperation rate to be easily converted or reversible. It should then be considered in the armamentarium of bariatric surgeons. * After ressuscitation, SG = sleeve gastrectomy, PPI: proton pomp inhibitors. Figure 8. Algorithm for revisional surgery after failed MGB. 136 Jean-Marc Chevallier REFERENCES [1] Sjostrom, L., Narbro, K., Sjostrom, D., Karason, K., Larsson, B., Wedel, H., et al., Effect of bariatric surgery on mortality in Swedish obese subjects. NEJM. 2007; 357:741-52. [2] Lönroth, H., Dalenbäck, J., Hagling, E., Lundell, L. Laparoscopic Gastric bypass. Surg. Endos. 1998; 10:636-38. [3] Lee, W. J., Yu, P. J., Wang, W., et al., Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity. Ann. Surg. 2005; 242:20-28. [4] Fisher, B. L., Buchwald, H., Clark, W., Champion, J. K., Fox, S. R., MacDonald, K. G., Mason, E. E., Terry, B. E., Schauer, P. R., Sugerman, H. J. Mini-gastric bypass controversy. Obes. Surg. 2001; 11: 773-777. [5] Carbajo, M., Garcia-Caballero, M., Toledano, M., Osorio, D., GarciaLanza, C., Carmona, J. A. One-anastomosis gastric bypass by laparoscopy: results of the first 209 patients. Obes. Surg. 2005;15(3): 398-404. 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Obes. Surg. 2014:24; 1744-45. Fobi, M. Banded gastric bypass: combining two principles. 2004 ASBS Consensus Conference. Surg. Obes. Relat. Dis. 2005 May-june; 1(3): 304-9. Irani, K., Youn, H. A., Ren-Fielding, G. A., et al., Mid-term results for gastric banding as salvage procedure for patients with weight loss failure after Roux-en-Y gastric bypass. Surg. Obes. Relat. Dis. 2011 mar-Ap; 7 (2):219-24. Betty, M. L., Underhill, M. B. Intestinal length in man. Br. Med. J. 1955; 19:1243-46. Himpens, J., Dapri, G., Cadière, G. B. Laparoscopic conversion of the gastric bypass into a normal anatomy. Obes. Surg. 2006 Jul; 16(7): 90812. In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 8 SURGICAL PROCEDURES FOR FAILURE OF BILIOPANCREATIC DIVERSION WITH DUODENAL SWITCH (BPD-DS) Simon Marceau, MD, FRCS (c), Simon Biron, MD, MSc, FRCS (c), Frédéric-Simon Hould†, MD. FRCS (c), Stefane Lebel‡, MD, FRCS (c), Odette Lescelleur§, MD, FRCS (c), Laurent Biertho#, MD, FRCS (c) and Picard Marceau, MD, PhD, FACS, FRCS (c) Bariatric Surgeon, IUCPQ, Laval University Québec (Québec), Canada Corresponding author: Simon Marceau, MD, FRCS (c). Department Head. Bariatric Surgeon. IUCPQ, Laval University. 2725, chemin Ste-Foy. Québec (Québec) G1V 4G5. Tél.: (418) 656-4810. Fax.: (418) 656-4825. Email: [email protected]. Email: [email protected]. † Email: [email protected]. ‡ Email: [email protected]. § [email protected]. # [email protected]. Email: [email protected]. 140 Simon Marceau, Simon Biron, Frédéric-Simon Hould et al. ABSTRACT We are presenting our experience in dealing with patients on whom BPD-DS has caused either excessive malabsorption or insufficient weight loss. We discuss the decision making to proceed with changing the architecture of the intestinal bypass and what procedure was used to resolve the problem. Suggestions are given on how each procedure was performed and the results obtained from each of these. In conclusion failure after BPD-DS is relatively rare and revision for denutrition is usually simple and efficient. A complete reversal of the procedure is also feasible. INTRODUCTION BPD-DS is a safe and very efficient procedure when follow-up is appropriate. It can but rarely fail by causing either excessive malabsorption or not enough weight loss and will require revisional surgery. Recently we reported a review of 2615 consecutive patients submitted to a BPD-DS between 1992 and 2010. 95% of these patients were followed up with a visit or blood work within the last 2 years with a mean follow-up of 9.6 years (range 2 to 20 years) [Ref]. We reported that 2.9% (n:78) of these patients required the intestinal diversion be restored either for excessive malabsorption (n:37) or for insufficient weight loss (n:41). In the present chapter we will focus on these patients and will discuss the type of procedure used. We will first present the possible revisions for malabsorption and then the revisions for insufficient weight loss. Revision for Malabsorption BPD-DS by decreasing bile contact with food permanently compromises absorption of fat, liposoluble vitamins and calcium. This is usually easily compensated with appropriate supplements. However by shortening the functional intestine by about half, it temporarily compromises protein absorption in about 20% of the patients for the first year. This is followed by spontaneous recovery for the great majority of patients particularly with appropriate treatment. In a few patients, protein absorption remains under Surgical Procedures for Failure of Biliopancreatic Diversion … 141 normal levels, and resists to medical treatment. A decision needs to be taken to modify the architecture of the bypass. Circumstances dictate the timing to do so. There is not one perfect timing for reoperation, since it depends on patients‟ collaboration, easiness of follow-up and severity of patients‟ symptoms. One needs to keep in mind the risk of hypoalbuminemia on the liver, which may be life threatening when hypoalbuminemia reaches levels below 25g/l. We report our own experience hereunder. Patient Characteristics During our 20-years of experience with BPD-DS, a decision was made to modify the bypass in 28 patients and to completely reverse the bypass in 9 (for a prevalence of revision for malabsorption of 1.4%). The reasons that forced the decision to modify the bypass were complex but the dominant factor was recurrent protein deficiency in 15; diarrhea in 8; abdominal pain in 4; persistent anorexia in 7 and persistent asthenia in 3. There were also aggravating factors complicating the situation. Nine patients were drug addicts, 5 presenting with psychiatric problems, 4 with excessive use of alcohol and in 4 the situation was aggravated by the appearance of concomitant diseases (2 cancers, 1 lupus and 1 cirrhosis). The bypass was almost completely dismantled in 9 patients. This group was younger (38 vs 51 years old) and the decision was delayed (8 vs 4 yrs) compared to the group whose bypass was only lengthened. Surgical Approach In 80% of patients measures of the intestinal segments before revision were found to be within 10% the expected length: Total Alimentary Channel (TAC) 250 cm and Common Channel (CC) 100 cm. In 20% it was found to be longer, with variation in the 50 to 100% range for the TAC and between 100 and 175% for the CC. None of the patients were found with channels shorter than expected. Isolated lengthening of the CC (which is rarely done for diarrhea), can be realized by moving the the ileo-ileal anastomosis upward at the desired level on the TAC channel (Figure 1). 142 Simon Marceau, Simon Biron, Frédéric-Simon Hould et al. Figure 1. Lengthening only the Common channel. To lengthen only the common channel for controlling diarrhea, the ileo-ileostomy can be displaced more proximally on the total alimentary channel. It implies a mesenteric closure and a new end to side ileo-ileostomy. TAC: Total alimentary channel; CC: Common Channel; BC: Biliary Channel. For lengthening both the TAC and the CC one can either move the distal end of the strict alimentary channel to an appropriate level on the biliary channel (BC) requiring one closure and one anastomosis (Figure 2) or use a "kissing anastomosis method" (side to side) without any closure, between TAC and BC. This technique is easier but leaves a loop in place (Figure 3). In our experience, the lengthening varied from 50 to 300cm for a mean of 100 cm. On the other hand, 3 different techniques are available to completely or almost completely reverse the intestinal bypass. For complete reversal it is possible to take down the duodeno-ileostomy and to do a new duodenoduodenal anastomosis with the duodenal-stump, and complete the procedure by replacing the previous latero lateral anastomosis for a new end to end ileoileostomy. It requires a closure of the mesenteric window, and 2 new anastomosis (Figure 4). To avoid dissecting the duodenal area and to do an almost complete reversal is possible through two methods. Surgical Procedures for Failure of Biliopancreatic Diversion … 143 Figure 2. Lengthening both the total alimentary and common channels. The total alimentary channel (TAC) is transected with a mechanical device above the ileoileostomy and reanastomosed at an appropriate level on the biliary channel (BC). Both TAC and Common Channel (CC) are lengthened for an equivalent length. The same method can be used for a "nearly complete reversal" if the reanastomosis between the proximal TAC and the proximal jejunum is done as close as possible to the ligament of Treizt. Figure 3. Kissing anastomoses for lengthening both TAC and CC. A kissing anastomosis (side to side) between TAC and BC forming a loop will lengthen both TAC and BC for an equivalent length. This is the simplest technique and requires only one anastomosis. TAC: Total alimentary channel; CC: Common Channel; BC: biliary Channel. 144 Simon Marceau, Simon Biron, Frédéric-Simon Hould et al. Figure 4. Complete reversal. The duodeno-ileal anastomosis is taken down and a new duodeno-duodenal anastomosis is done with the duodenal stump. The end of the previous biliary channel is then connected to the origin of the previous total alimentary channel. It requires a mesenteric closure and 2 anastomosis. TAC: Total alimentary channel; CC: common channel; BC: biliary channel. One technique is to do an end to side ileo-jejunostomy as close as possible from both the duodenal area and the Angle of Treitz at ±20 cm from each one and replace the initial ileo-ileostomy by a new end to end ileo-ileostomy. It requires a closure of the mesenteric window and 2 anastomosis. The other technique consists of using the same approach as for lengthening both the TAC and CC (Figure 2) and to do the reconnection as high as possible to the proximal jejunum close to the angle of Treitz. This requires only one mesenteric window closure and a single anastomosis. With these 3 different methods patients end up with a sleeve gastrectomy with either a normal intestinal tract; or with about 40 to 150 cm biliary bypass. This last method is obviously easier and requires only one small bowel anastomosis. The long-term risk of peptic ulcer is considered negligible. Results The lengthening of the intestinal segments was efficient to correct the malabsorption in 80% of the patients. The remaining 20% of patients required Surgical Procedures for Failure of Biliopancreatic Diversion … 145 re-lengthening or complete reversal of the duodenal switch. In terms of weight gain there was none in one third of the patients, and the other two-third gained 8 to 45 kg. There was one operative death in this group of 37 patients. The mean follow-up after revision was 5.5 years. Late unrelated death was not different than for the whole group. There were 2 suicides (1 and 8 years after revision) and 2 deaths from pulmonary insufficiency (2 and 4 years after revision). After complete or nearly complete reversal malabsorption ceased and a mean 32 kg weight regain occurred (range: 18 to 74 kg). When the decision for reversal was triggered by the presence of chronic abdominal pain (n:4) this symptomology persisted despite complete revision. There was no major complication following reversal. Conclusion in Regard to Revision for Malabsorption The need to surgically correct BPD-DS for excessive weight loss and/or malnutrition was rare (1.4%). It usually occurred in patients presenting with other aggravating factors making the evaluation and the follow-up difficult. It was also precipitated by the appearance of unexpected associated disease. The decision between lengthening the non-bypassed bowel versus a complete reversal depends on the severity of the malnutrition and the difficulty of follow-up. When lengthening is done, it should be done at the expense of the biliary limb and both the common channel and alimentary channel are lengthened: The kissing anastomosis technique is easier because it limits the procedure to only one new anastomosis but the long term risk of creating a loop has not yet been demonstrated. Lengthening of the alimentary tract usually does not result in major weight gain and relieves the malabsorption in 80% of the patients. A complete reversal removed the malabsorption but was also followed by major weight regain. The surgical technique consisting in joining the distal end of TAC (transected above the ileo-ileostomy) to the proximal jejunum (end-to-side) is easier and leaves the patient with only a duodenal diversion and a 150 cm short bypass. 146 Simon Marceau, Simon Biron, Frédéric-Simon Hould et al. REVISION FOR INSUFFICIENT WEIGHT LOSS Patient Characteristics Definition of "insufficient weight loss" after bariatric surgery is not yet clearly defined. It is generally agreed that a BMI ≥40 represents a handicap sufficient in itself to justify surgery, hence we consider failure when a patient with an initial BMI greater than 50 does not reach a BMI below 40 or when a patient with an initial BMI less than 50 does not reach BMI less than 35. This goal is reached in almost 90% of cases after BPD-DS with a mean weight loss of 55 kg. The decision to proceed with a revision for insufficient weight loss depends essentially on patients themselves in relation to the risk involved. In this series, 40 patients required a revision for insufficient weight loss. Revision was performed at a mean 8 years after the primary surgery (range: 1 to 15 years). Overall the group had lost a mean of 31.5 kg; their BMI was 40.3 ±5.7; the gender ratio (f/m) was 31/9 and their mean age 47 years old. Two of them were patients with Prader-Willi syndrome. Surgical Procedure In 8 patients, before revision was done, the measurement of both the alimentary and common channel were found to be as expected (250/100 cm); in 14 they were elongated by 20 to 80% and in the other 18, the measures were not reported. In 13 patients, it was decided to do only a shortening; in 18 only a resleeve and in 9 a re-sleeve plus a shortening was performed. When shortening was done the goal was to restore the initial intestinal length (250/100 cm). A segment of the TAC was resected including the ileo-ileal anastomosis, and a new end to end ileo-ileostomy and a new end to side ileo-ileal anastomosis at 100 cm from the ileo-ceacal valve were performed. RESULTS One patient suffering from Prader-Willi died early after re-sleeve and shortening. There were 4 late deaths from unrelated causes: (trauma after 10 years, cancer after 16 and 20 years, cerebral vascular accident after 20 years). Surgical Procedures for Failure of Biliopancreatic Diversion … 147 After shortening (n:13) an additional 14 kg weight loss (range: 3-38 kg) was obtained, with a follow-up of 8 years and a final total weight loss of 49 kg and final BMI of 34 without protein malabsorption. Only one patient required a second shortening. Re-sleeve only (n: 18) resulted in additional weight loss similar to shortening of the intestine (19 vs 14 kg) (p = 0.18). Intestinal shortening accompanied by regastrectomy did not increase weight loss but this addition was undertaken in patients who had already shown greater resistance to weight loss after the initial procedure having lost only 22 kg versus 35 kg for the others. Furthermore this latest group remained with a greater BMI (42 vs 34 kg/m2) and a lower percent excess weight loss (35 vs 63), at a mean 16 years after the initial surgery, confirming their weight loss resistance. Conclusion Regarding Reoperation to Add Weight Loss Revision for insufficient weight loss is rarely necessary after BPD-DS (1.6%). If intestinal segments are found within the expected length, a simple regastrectomy would seem the procedure of choice with better additional weight loss. For patients who initially show resistance to weight loss, the addition of a regastrectomy together with shortening of the bowel will almost double the initial weight loss without protein malabsorption. With this strategy a second attempt gave an additional 14 kg weight loss. GENERAL CONCLUSION Lengthening the functional intestine will be efficient to cure protein malabsorption in 80%, and cause minimal weight gain. However 20% of the patients will eventually require a total reversal. For increasing weight loss, regastrectomy was more efficient than shortening of the functional intestine but we believe that when the channels are found to be 50% longer than expected, they should also be shortened and if there is evidence of resistance to weight loss, an attempt to restore the proper length of the bypass is indicated. 148 Simon Marceau, Simon Biron, Frédéric-Simon Hould et al. ACKNOWLEDGMENTS Sincere thanks to Paule Marceau, databank manager who assisted for the collection of data and to Helene Trudel from the department of Audiovisual for the figures. REFERENCE Marceau P, Biron S, Marceau S, Hould FS, Lebel S, LeScelleur O, Biertho L, Simard Serge, Kral JG. Long-Term Metabolic Outcomes 5 to 20 Years after Biliopancreatic diversion. OBES SURG doi 10.1007/s/1695-0151599-5. In: Management for Failed Bariatric Procedures ISBN: 978-1-63483-753-8 Editors: J. Himpens and R. Vilallonga © 2015 Nova Science Publishers, Inc. Chapter 9 FAILED BPD Giuseppe Maria Marinari1,, Vincenzo Borrelli1 and Luc Lemmens2 1 Humanitas Gavazzeni, Bariatric Unit, Bergamo, Italy 2 AZ Nikolaas, Sint-Niklaas, Belgium ABSTRACT The failure in weight loss after BPD is an unpleasant event and it is poorly described in the literature: little has been written on the rate of inadequate weight loss, and how to handle it. From the limited available data it seems that after BPD weight loss is less than 50% of the excess weight in about 10% of cases The solution to this issue varies depending on the eating habits of the patients and on their tolerance to side effects and diet that BPD entails. Surgery can be an eventual solution to weight loss failure but patients should be informed of the small size of the data on which to decide. 1. INTRODUCTION Insufficient weight loss and weight regain constitute an important problem for all bariatric procedures. The percentages of these problems will vary Corresponding author. Giuseppe Maria Marinari, Humanitas Gavazzeni, Bariatric Unit, Va Mauro Gavazzeni 21, 24125 Bergamo, Italy, [email protected]. 150 Giuseppe Maria Marinari, Vincenzo Borrelli and Luc Lemmens depending on the different procedures: 50% or more for adjustable gastric banding (AGB), 20 to 30% for the standard gastric bypass (SGB), 30 to 50% for the sleeve gastrectomy (SG). BPD or BPD-DS are still considered the most powerful operation in terms of weight loss, weight maintenance and resolution of co-morbidities. Nevertheless this procedure is not free of failures. There are few data published on this topic, but failures occurred in 8 - 10% of our patients. Because of their efficacy malabsorptive procedures are actually considered the most powerful procedure, not only as a primary but especially as a redo procedure after the failure of a restrictive operation [1, 2, 3]. In the author‟s series weight loss after BPD can be considered very good: at two years a mean BMI of 27 is reached, and the weight loss is sustained, leading to a mean BMI of 28 in the long term. Nevertheless, even BPD can fail in some cases, particularly in long term follow up: since few papers face this problem, it is difficult to estimate at which percentage a failure can happen. In the few papers available the failure rate varies from 1.5% [4] to 10% [5]: as far author‟s unpublished data, in GMM - VB series in 2.1% of cases the weight loss was less than 25% of the excess weight (EW) and in 8.1% the weight loss was less than 50% of the EW, whilst in LL series, in 2.3% of cases the BMI remained over 35, and 8% regained weight (unpublished data). Goal of this chapter is trying to determine an algorithm to manage a malabsorption failure. 2. REASONS FOR FAILURE There are three main reasons for failure to loose sufficient weight or for weight regain after BPD. 1. Sweet eating is a pitfall for all type of procedures. Although BPD is a malabsorptive procedure, simple sugars absorption is preserved and there is no restriction in the food intake. This may lead to an extra absorption of hundreds of calories per day, particularly when these sweets are taken in between meals. This drawback must be explained to patients before the operation and must be repeated later during consultation: unfortunately, people sometimes become sweet eater after surgery. 2. Hunger. As in other bariatric procedures, in very early follow up the hunger feeling is diminished after BPD due to the reduced gastric volume and to the change in gut hormones. In contrast with other Failed BPD 151 procedures, while BPD patients are able to eat normal meals early after the operation they usually manage to keep their weight loss. It has been shown that after BPD a threshold mechanism of absorption for fat and starch [6] should allow to eat great amount of food at a stable weight, provided it happens in three-four meals per day. Per meal only 300 til 500 Kcal can be absorbed. Extra meals or grazing will jeopardize this mechanism of weight maintenance: in a BPD series of 15 subjects with Prader Willi Syndrome, where a compulsive hyperphagia is present, half of the patients were failures [7]. After a longer period of follow-up some patients will start to complain of a significant increase in the hunger feeling with polyphagia and hyperphagia, and therefore of weight regain as a consequence. This must be highlighted, because compulsiveness and eating disorders have been suggested as particular indications to BPD, but at the same time they can be reason of a BPD failure. 3. Intestinal adaptation [8], can be a reason of weight regain in a few patients. The diagnosis is difficult and can only be made after exclusion of other reasons (i.e., sweet eating or grazing) of weight regain. It should only occur several years after the operation. 3. TREATMENT The first step in tackling weight issues after BPD is always an in-depth nutritional counseling in order to evaluate: 1) 2) 3) 4) Daily simple sugar intake Daily protein intake Number of meals per day Presence of compulsive hyperphagia Different causes of weight regain will need different solutions. a) Sweet eating. There is no surgical solution in case of pure sweet eating: if the patient cannot control it, the help of a dietician and a psychological support can be offered. Results are strongly dependent on patient compliance b) Compulsive hyperphagia. Patients can become very hungry several years after BPD and some of them will start eating several times per 152 Giuseppe Maria Marinari, Vincenzo Borrelli and Luc Lemmens day and even during the night. These patients may complain of frequent large stools and weight regain will be an important problem. Psychological support can be offered, but results are in most of the cases disappointing. In case of polyphagia with enough protein intake (> 150 g per day) and normal albuminemia, a surgical solution may be proposed. The resection of the stomach fundus (Figure 1), similar to Sleeve Gastrectomy, can decrease the ghrelin‟s levels and therefore may induce weight loss (9). Literature is sparse and inaccurate: it is impossible to predict how much of the excess weight can be lost with this type of revisional surgery. The risk of protein malnutrition should always be kept in mind: in this case a further revision to gastric bypass will still be possible. Nevertheless, in LL unpublished data, this type of revision has led to a good weight loss (about 10 points of BMI). In 19 patients the BMI had initially decreased from 46,3 to 27,7 after the BPD. On the long run there was a weight regain to a BMI of 36,3 and a fundus resection was performed. After revision there was an average BMI loss of 10 points down to 25,9. Three patients suffered from protein deficiency and 2 of them needed TPN. Also other authors suggest a secondary Sleeve Gastrectomy as a solution after BPD failure [9]. c) Intestinal (over)adaptation. When there is no sweet eating, protein intake is adequate (80-100 g/day), eating habits are regular (3, maximal 4 meals per day), and volumes unchanged intestinal (over)adaptation must be ruled out. The solution one may offer is a limb length revision, with shortening of both the alimentary and the common limb. Unfortunately, there is no literature on this subject. There was only a short experience of one of the authors (GMM) at University of Genoa School of Medicine with Scopinaro‟s series. Shortening the limb length was attempted in 4 cases. The revision was practically ineffective in 3 long term patients and led to a small BMI loss in 1 patient, who had been operated on elsewhere just 18 months before, and in whom the limbs were too long. In analogy with previous reoperations performed for incisional hernias years after standard BPD (alimentary limb cm 200, common limb cm 50) in patients with good weight loss (> 70% of EW) and good nutritional status, in whom the length of the alimentary and of the common limb was found to be cm 240 and cm 70 respectively, in the 4 cases cited above, the alimentary and the common limb length was shortened to cm 240 and to cm 70 respectively (Figure 2). Revision was uneventful Failed BPD 153 both on bowel movements and on protein levels. Shortening the alimentary and the common limb in order to provide a better weight loss is a big challenge: an aggressive revision could lead to protein malnutrition and excessive bowel movements, whilst a limited shortening will be ineffective. Figure 1. Resection of the stomach fundus. d) In case of unsatisfactory weight loss in BPD patient with low tolerance, i.e., excessive bowel movements or protein deficiency, a conversion to gastric bypass is feasible (Figure 3). This is quite a drastic intervention since BPD must be taken down altogether and converted into a regular gastric bypass. This includes a subtotal gastrectomy, which makes the operation irreversible. Patients with an intestinal (over)adaptation may be converted into a gastric bypass as 154 Giuseppe Maria Marinari, Vincenzo Borrelli and Luc Lemmens well. The early results of conversion are good with an acceptable weight loss, normalization of bowel movements and normalization of vitamin A, E and K; in case of protein malnutrition, serum proteins levels will come to normal values. However, in the longer follow-up, in comparison with a primary gastric bypass, a higher risk of weight regain has been observed. For this reason one of the authors (LL) suggests now a banded gastric bypass, with a silicone ring of 6.5 or 7 cm. Nevertheless, conversion into a gastric bypass is the best solution for patients with BPD side effects: protein malnutrition, excessive bowel movements, vitamin deficiencies, odor problems, other. This conversion can easily be done by laparoscopy, especially in case of previous laparoscopic BPD. In the medium term follow-up the authors found a loss of about 5 points in BMI. Figure 2. Shortening of the alimentary limb and of the common channel. Failed BPD Figure 3. Conversion to Roux-en-Y gastric bypass. Figure 4. Algorithm for the management of BPD failure. 155 156 Giuseppe Maria Marinari, Vincenzo Borrelli and Luc Lemmens CONCLUSION About 10% of patients after BPD will have an insufficient weight loss or a weight regain. Because of the large burden of nutritional consequences and side effects that malabsorption entails, the number of failures should be reduced by selecting and directing sweet eaters to strategies other than BPD. Nevertheless, some patients will fail in any case, due to compulsive hyperphagia or intestinal adaptation. The first step in finding a solution is a thorough nutritional counseling, and only in very selected cases can a surgical revisio be suggested. Compulsive hyperphagia with high daily protein intake can be addressed by a stomach fundus resection, whilst regular eating habits and low tolerance for BPD side effects or for high-protein diet can be addressed by conversion of BPD into a gastric bypass (see Algorithm in Figure 4). Before surgical revision of the biliopancreatic diversion patients should be fully informed that: 1. very few data are available on BPD revision; 2. in case of stomach fundus resection the reduced intake of food could lead to protein malnutrition; 3. the conversion to gastric bypass involves a subtotal gastrectomy. Conversion to gastric bypass is an effective solution for BPD side effects but very little is known about weight effect in the long term. REFERENCES [1] [2] [3] Elnahas A, Graybiel K, Farrokhyar F, Gmora S, Anvari M, Hong D. Revisional surgery after failed laparoscopic adjustable gastric banding: a systematic review. (2013) Surg. Endosc.; 27:740-5. Daskalakis M, Scheffel O, Theodoridou S, Weiner RA. (2009) Conversion of failed vertical banded gastroplasty to biliopancreatic diversion, a wise option. Obes. Surg.; 19:1617-23. Keshishian A, Zahriya K, Hartoonian T, Ayagian C. (2004) Duodenal switch is a safe operation for patients who have failed other bariatric operations. Obes. Surg.; 14:1187-92. Failed BPD [4] [5] [6] [7] [8] [9] 157 Marceau P, Biron S, Hould FS, Lebel S, Marceau S, Lescelleur O, Biertho L, Simard S. (2007) Duodenal switch: long-term results. Obes. Surg.; 17:1421-30. Slater G, Duncombe J, Fielding GA. (2005) Poor weight loss despite biliopancreatic diversion and subsequent revision to a 30-cm common channel after initial laparoscopic adjustable gastric banding: an analysis of 8 cases. Surgery for Obesity and Related Diseases; 1: 573 – 579. Scopinaro N, Marinari GM, Pretolesi F, Papadia F, Murelli F, Marini P, Adami GF. (2000) Energy and nitrogen absorption after biliopancreatic diversion. Obes. Surg.; 10:436-41. Marinari GM, Camerini G, Novelli GB, Papadia F, Murelli F, Marini P, Adami GF, Scopinaro N. (2001) Outcome of biliopancreatic diversion in subjects with Prader-Willi Syndrome. Obes. Surg.; 11:491-5. Friedman D, Marinari G, Camerini G, Baschieri G, Simonelli A, Scopinaro N. (1997) Morpho-functional adaptation and motility of the small intestine and colon after extensive intestinal exclusions G Chir.; 18:785-91. Gagner M. (2010) Laparoscopic revisional surgery after malabsorptive procedures in bariatric surgery, more specifically after duodenal switch. Surg. Laparosc. Endosc. Percutan. Tech.; 20: 344-347. INDEX A abolition, 94 abuse, 91 acarbose, 110 access, 44, 64, 88 accommodation, 37 acid, 36, 43, 44, 47, 104, 105, 115, 123 ADA, 10 adaptation, 151, 152, 153, 156, 157 adhesions, 49, 50, 99, 104, 128 Adjustable Banded RYGB, 62 adjustable gastric band, 17, 52, 53, 57, 58, 69, 70, 71, 75, 82, 150, 156, 157 adjustment, 60, 65 adults, 10, 21, 118 age, 10, 14, 76, 80, 130, 146 alcohol consumption, 43 algorithm, 31, 34, 81, 134, 150 alimentary limb (AL), 88, 89, 90, 98 alimentation, 130 allergy, 6 analgesic, 28 anatomical aberrations of the bypass, 88 anatomy, 2, 5, 6, 38, 39, 53, 54, 75, 88, 92, 99, 104, 111, 114, 118, 121, 122, 130, 131, 132, 134, 138 anemia, 121 anesthesiologist, 94 angina, 15 angulation, 42 anorexia, 141 antrum, 95, 99, 101, 103 arterial hypertension, 93 asparagus, 67 aspiration, 37, 53 aspiration pneumonia, 53 assessment, 27, 34, 38, 44, 46, 47, 49, 54, 92, 117, 127, 134 asthenia, 141 asymptomatic, 43 atherosclerosis, 14 B Band Failures, v, 57, 59 bariatric procedures, 9, 24, 25, 32, 36, 58, 74, 75, 82, 84, 88, 91, 137, 149, 150 bariatric-metabolic surgery, vii barium, 5, 37, 106 base, 39 behavior modification, 2 behaviors, 7 Belgium, 87, 149 beneficial effect, 15 benefits, 14, 15, 16, 74, 97 bezoar, 67 bile, 117, 120, 121, 122, 123, 134, 140 biliary peritonitis, 117, 122, 134 160 Index biliopancreatic diversion, 25, 60, 67, 70, 84, 101, 113, 156, 157 blame, 115 bleeding, 26, 27, 28, 30, 75, 77, 80 blood, 4, 11, 12, 13, 14, 15, 27, 28, 31, 33, 51, 91, 94, 121, 140 blood pressure, 11, 14, 15 blood supply, 33, 94, 121 blood transfusion, 31 body mass index (BMI), 11, 12, 14, 15, 16, 21, 25, 26, 51, 62, 63, 71, 76, 77, 80, 81, 95, 120, 126, 127, 130, 146, 147, 150, 152, 154 body weight, 7, 15, 26 bone, 55 bowel, 30, 31, 36, 53, 59, 62, 63, 64, 97, 102, 106, 108, 111, 112, 122, 130, 144, 145, 147, 153 bowel obstruction, 30, 31 Brazil, 9 bronchial epithelium, 37 burn, 48 C cachexia, 2 calcium, 140 caliber, 35 calibration, 126 cancer, 2, 146 candidates, 18, 93, 97 capillary, 13, 14 car accidents, 109 carbohydrates, 91, 93, 108, 109 cardiovascular disease, 16 cardiovascular risk, 14, 16, 20, 21 case study, 84 category b, 18 catheter, 131 cellulose, 104, 105 cheese, 6 China, 15 cholesterol, 14, 20 chronic fatigue, 109 chyle, 108 cigarette smoking, 105 cirrhosis, 141 clinical symptoms, 24, 109 cloaca, 106 closure, 67, 89, 104, 106, 108, 112, 142, 144 collaboration, 141 colon, 89, 157 color, 28 communication, 7, 104 community, 55, 88 complement, 101 complete blood count, 27 compliance, 7, 57, 59, 87, 92, 93, 96, 97, 98, 151 complications, 2, 4, 8, 19, 24, 25, 26, 27, 28, 30, 33, 37, 38, 40, 41, 49, 50, 51, 52, 53, 54, 55, 57, 60, 61, 62, 67, 70, 73, 74, 75, 76, 77, 78, 80, 82, 83, 88, 91, 95, 96, 97, 110, 111, 118, 121, 127, 137 composition, vii computed tomography, 24, 29, 40, 53, 54, 55, 137 consensus, 26, 28, 77, 84, 138 constant rate, 83 construction, 38, 44, 88, 89, 90, 91, 92, 93, 97, 110 consumption, 43 contraction, 107 controlled studies, 14, 82 controlled trials, 21 controversial, 137 conversion, 3, 7, 48, 57, 59, 60, 62, 64, 65, 66, 67, 68, 70, 71, 72, 76, 77, 78, 80, 82, 84, 92, 97, 114, 117, 118, 121, 122, 123, 134, 138, 153, 156 cooperation, 55 coronary heart disease, 10 correlation, 11, 12, 15, 58 cost, 10, 30, 76, 80, 82 counseling, 6, 19, 60, 66, 75, 108, 151, 156 criticism, 118, 122 CRP, 27, 28, 31 CT scan, 30, 31, 33, 37, 38, 41, 67, 106 cure, 97, 147 Index D danger, vii, 134 deaths, 15, 145, 146 defects, 36, 89, 90, 108, 112 deficiencies, 91, 97, 112, 154 deficiency, 130, 131, 141, 152, 153 deflation, 66, 67, 68 deformation, 106 dehiscence, 94 delayed gastric emptying, 75 depth, 151 detection, 28, 47 developed countries, 24 developing countries, 23, 24 deviation, 27, 28, 30 diabetes, 9, 10, 11, 12, 15, 16, 18, 19, 20, 21, 26, 93, 115, 127 diabetes mellitus, 9, 20, 21 diabetic patients, 12, 14, 15, 19, 21 diarrhea, 80, 109, 130, 131, 141, 142 diet, 3, 4, 7, 13, 16, 59, 65, 91, 96, 98, 149, 156 dietary habits, 59, 87, 91, 108 dilation, 5, 6, 55, 58, 59, 62, 65, 66, 75, 88, 91, 96 disability, 10 discomfort, 48 diseases, 9, 10, 11, 19, 93, 141 dislocation, 65 displacement, 33 dissatisfaction, 26, 48 distal gastric bypass, 97, 101, 114 diversity, vii drainage, 31 drug addict, 141 drugs, 12 dumping, 4, 36, 93, 109, 110 duodenal switch, 25, 47, 60, 70, 74, 79, 82, 83, 84, 85, 127, 145, 157 duodenal ulcer, 106 duodenum, 52, 74, 88, 110 dyslipidemia, 15, 93 dysphagia, 42, 48, 77, 104, 106 dysplasia, 122 161 dyspnea, 28 E eating disorders, 117, 151 education, 2, 21, 65 effluent, 28 effusion, 30 Egypt, 23 elongation, 5, 6 e-mail, 57 emergency, 10, 68, 108 emission, 9 encephalopathy, 44 endocrinologist, 92, 93 endoscope, 42, 44, 48 endoscopy, 2, 5, 24, 38, 42, 43, 44, 46, 47, 48, 60, 93 enlargement, 6, 35, 37, 47 epidemic, 10, 23, 24 epithelium, 37 ERD, 77 erosion, 5, 33, 40, 47, 48, 55, 58, 59, 62, 63, 64, 66, 67, 72, 95, 105 ESO, 104 esophagus, 59, 66, 74, 104, 105, 122 etiology, 115 evacuation, 31, 36 evidence, 5, 9, 14, 28, 77, 115, 147 evolution, 11, 88, 91, 93, 96 exclusion, 151 exercise, 4, 7 expenditures, 10 exposure, 30, 36, 40 extraction, 48 F fasting, 11, 13, 14, 15, 18, 37, 39, 41 fasting glucose, 18 fat, 48, 140, 151 fever, 27, 28, 31 fibers, 67 fibromyalgia, 109 162 Index fibrosis, 75 films, 36 fistulas, 61 fitness, 15 fixation, 66, 107 flaws, 2, 88, 91, 108 fluid, 31, 33, 36, 108 food, 26, 43, 66, 67, 68, 75, 91, 92, 108, 140, 150, 151, 156 food intake, 150 formation, 32, 36, 38, 40, 43, 47, 49, 106 formula, 5 France, 117 G gangrene, 33 gastric pouch, 5, 6, 33, 36, 37, 38, 39, 43, 54, 61, 62, 76, 79, 89, 92, 94, 95, 96, 97, 98, 104, 117, 118, 122, 123, 124, 126, 127, 128, 134 gastrin, 105 gastritis, 47, 48 gastro-enteral anastomosis, 95, 98 gastroenterologist, 92, 93 gastroenterostomy, 36, 37, 40 gastroesophageal reflux, 7, 56, 115 gastrointestinal bleeding, 28 gastrojejunostomy, 4, 5, 6, 42, 118, 122, 123, 124, 132 Germany, 23, 70 glucagon, 39 glucose, 11, 12, 13, 14, 18, 91, 109, 115 grading, 56 granules, 39 grazing, 97, 151 growth, 24 guidance, 42, 110 H healing, 108 health, 3, 7, 10, 15, 118 health expenditure, 10 health insurance, 7 heart disease, 10, 15 heartburn, 122 hematemesis, 28 hematoma, 31 hemoglobin, 11, 16, 27, 28 hemorrhage, 52 hernia, 5, 6, 30, 31, 36, 53, 56, 66, 71, 89, 91, 107, 115, 121 hernia repair, 6, 115 herniated, 33, 108 hiatal hernia, 5, 6, 32, 35, 40, 48, 50, 56, 66, 71, 91, 115 history, 3, 19, 47, 82, 93 hormone, 101 hormones, 2, 150 hospitalization, 15 hypercholesterolemia, 14 hyperplasia, 122 hypertension, 14, 15, 26, 93 hypertriglyceridemia, 14 hypoglycemia, 4, 7, 98, 109, 110, 115 hypotensive, 6 hypothesis, 2, 20, 106 I ideal, 93, 114 identification, 98, 128 ileostomy, 142, 143, 144, 145, 146 images, 39 impairments, 10 improvements, 15 impulses, 106 incarceration, 68 incidence, 15, 19, 23, 30, 42, 43, 51, 65, 73, 75, 77, 82, 95, 107, 108, 110, 118, 123 incisional hernia, 152 incisors, 5 India, 15 Indians, 21 individuals, 10, 21, 24, 91, 97, 98, 108, 109 infarction, 15, 20 infection, 33, 40, 43, 48, 62, 66, 77, 95, 131 inflammation, 42, 43, 67 Index inflation, 65, 67 ingest, 6 ingestion, 5, 67, 109 inhibition, 101, 109 injections, 109 injury, 30 insertion, 66 institutions, 24, 70 insulin, 11, 12, 13, 14, 15, 16, 19, 109, 110, 115 insulin resistance, 16 integrity, 92 intervention, 2, 7, 9, 10, 15, 16, 19, 21, 24, 25, 27, 31, 32, 38, 39, 40, 41, 48, 50, 59, 60, 87, 93, 96, 153 intestinal obstruction, 121 intestinal tract, 38, 144 intestine, 130, 140, 147, 157 intussusception, 30, 91, 106 inversion, 33, 46 iodine, 39 ischemia, 42, 43, 105 Islam, v, 23 Israel, 54 issues, 2, 4, 6, 30, 105, 111, 151 Italy, 149 J jejunum, 64, 119, 143, 144, 145 K kidney, 10 kidney failure, 10 L lactose, 6 lactose intolerance, 6 laparoscopy, 24, 31, 49, 50, 68, 88, 99, 136, 154 leakage, 26, 27, 28, 30, 32, 59, 60, 67, 75, 76, 77, 106, 118, 121, 122, 127, 134 163 leaks, 61, 117, 121 learning, 41 lesions, 58 leukocytosis, 27, 28, 31 liberation, 105 life expectancy, 118 lifestyle changes, 92 ligament, 77, 119, 143 light, 109 lipid metabolism, 115 lipids, 15 liver, 141 localization, 38 low-density lipoprotein (LDL), 11, 14 lower esophageal sphincter, 6 lumen, 48, 106 lupus, 141 lying, 95 M magnitude, 128 majority, 2, 11, 65, 74, 140 malabsorption, 2, 97, 114, 140, 141, 144, 145, 147, 150, 156 malnutrition, 97, 108, 117, 118, 120, 121, 124, 129, 130, 131, 132, 134, 145, 152, 153, 154, 156 management, 13, 14, 24, 27, 31, 38, 48, 51, 52, 53, 55, 78, 105, 111, 112, 115, 155 mass, 21, 51, 62, 63, 67, 76, 95 measurement(s), 5, 38, 46, 146 meat, 5 median, 11 medical, 3, 9, 10, 15, 21, 48, 54, 130, 131, 141 medical care, 16 medication, 11, 18, 19, 92 melena, 28 mellitus, 9, 20, 21 memory, 19 mesentery, 30, 90, 95, 112 meta-analysis, 21, 25, 51, 74, 83, 85, 115, 123 164 Index metabolic, v, 8, 9, 14, 21, 23, 51, 69, 73, 83, 112, 148 metabolic responses, 2 metabolism, 91, 109, 115 meter, 124 metformin, 12 methylene blue, 119, 128 migration, 26, 33, 55, 71 minigastric bypass, 137 modifications, 11, 60 Moon, 113, 115 morbidity, 10, 27, 51, 74, 76, 77, 82, 117, 126, 134 mortality, 10, 11, 15, 19, 20, 74, 75, 85, 118, 136 mortality rate, 10, 75 mucosa, 47 multidisciplinary consultation, 88 myocardial infarction, 15, 20 N nasogastric tube, 119 nausea, 4, 28, 36, 42, 106, 108, 122 necrosis, 68, 107 nephropathy, 19 Netherlands, 57, 77 neutrophils, 51 Nissen fundoplication, 6 nitrogen, 157 nursing, 10 nutrition, 131 nutritional status, 131, 152 O obesity, 2, 8, 10, 20, 23, 24, 30, 36, 38, 50, 52, 53, 54, 55, 57, 58, 69, 70, 71, 73, 74, 83, 85, 112, 113, 115, 117, 118, 131, 136, 137 obesity surgery, 30, 38 obstruction, 30, 31, 33, 59, 91, 104, 106, 121 occlusion, 108 oedema, 37, 44 oesophageal, 35, 43, 47, 56 omentum, 119, 128, 129 operations, 10, 51, 75, 77, 82, 88, 110, 114, 156 optimization, 55 organ, 30 outpatient, 10 overtime, 36 overweight, 24 P pacemaker, 106 pain, 27, 28, 31, 33, 48, 67, 68, 106, 107, 108, 109, 130, 141, 145 pancreas, 109 pancreatitis, 36 parenteral alimentation, 130 participants, 12 pasta, 5 pathology, 42 pathway(s), 34, 69 peptic ulcer, 137, 144 peptidase, 13, 14 peptide, 11 perforation, 32, 42, 65, 68, 105, 106 peritonitis, 37, 106, 117, 122, 123, 134 physiological mechanisms, 112 physiology, 2, 94, 113 pilot study, 55 pneumonia, 30, 53 policy, 66, 99, 108, 123 polypropylene, 104 poor weight loss, 70, 88, 157 population, 4, 10, 19, 23, 24, 126 population size, 24 positive correlation, 15 potential benefits, 74 Prader-Willi syndrome, 146 preparation, 6, 27, 118, 134 preservation, 101 prevention, 20, 21 principles, 3, 138 probability, 15 Index proteins, 154 proton pump inhibitors, 105 psychologist, 59, 92 public health, 118 public opinion, 58 Q quality assurance, 70 quality of life, 19, 137 questionnaire, 3 R radiation, 30, 37, 40, 54 reading, vii, viii reconstruction, 30, 38, 106 recovery, 108, 140 recurrence, 10, 12, 14, 16, 17, 18, 19, 42, 66, 105, 131 redo surgery, 127 redo-bariatric surgery, vii reinforcement, 119, 128 relevance, 137 remission, 9, 11, 12, 14, 15, 16, 18, 19, 20, 21, 26, 93, 101 repair, 6, 66, 67, 71, 104, 105, 115 resection, 58, 94, 105, 106, 107, 126, 127, 128, 132, 152, 156 resistance, 16, 147 resolution, 12, 65, 73, 74, 96, 112, 150 resources, 10 response, 11, 92, 109 restoration, 124, 131 restrictions, 92, 98 retinopathy, 19 revision, 3, 4, 7, 8, 25, 57, 59, 60, 63, 67, 69, 70, 73, 74, 75, 76, 77, 80, 82, 84, 114, 117, 118, 120, 121, 134, 140, 141, 145, 146, 152, 156, 157 Revisional bariatric surgery, 1, 2, 8, 83, 84 Revisional procedures, 127 revisional surgery, 2, 7, 18, 63, 75, 76, 79, 80, 82, 84, 135, 140, 152, 157 165 revisional weight loss surgery, vii rhythm, 131 risk(s), 1, 2, 14, 15, 16, 20, 21, 27, 37, 50, 51, 52, 58, 63, 67, 68, 74, 75, 77, 94, 97, 104, 105, 118, 123, 127, 130, 132, 134, 141, 144, 145, 146, 152, 154 risk factors, 14, 20, 21 Roux-en-Y gastric bypass, 8, 9, 10, 20, 25, 31, 52, 53, 55, 69, 70, 71, 72, 74, 82, 84, 87, 88, 89, 111, 112, 113, 114, 115, 118, 137, 138, 155 S safety, 11, 62, 71, 73, 74, 93, 111 saliva, 67 science, 69 sclerosis, 127 scope, 5, 96 secrete, 123 secretion, 110 security, 118, 124 selectivity, 109 seminars, 3 sensation, 4, 93 sensitivity, 28, 50 serum, 131, 154 shape, 37, 46, 92, 93, 122 showing, 10, 16, 24, 44, 76, 111, 131 side effects, 4, 77, 91, 97, 149, 154, 156 signs, 24 sleeve gastrectomy, 7, 17, 24, 25, 28, 30, 35, 37, 39, 40, 44, 46, 48, 51, 52, 53, 54, 55, 60, 69, 70, 74, 75, 76, 80, 82, 83, 84, 85, 90, 114, 118, 119, 134, 135, 144, 150 small intestine, 157 smoking, 42, 43, 105, 123 solution, 65, 93, 127, 149, 151, 152, 154, 156 South America, 15 Spain, 73, 87 sphincter, 6, 48, 101 spontaneous recovery, 140 standardization, 26 starch, 151 166 Index stasis, 36, 66 state, 87 stenosis, 25, 35, 36, 42, 44, 46, 47, 80, 107 stent, 84 stoma, 42, 43, 44, 114 stomach, 21, 33, 35, 36, 39, 42, 44, 47, 48, 52, 58, 59, 60, 61, 64, 66, 67, 68, 74, 75, 80, 88, 89, 94, 99, 101, 103, 104, 108, 110, 122, 123, 128, 129, 131, 134, 152, 153, 156 stress, 39 strictures, 4, 55, 75 stroke, 10, 15 structure, 100 style, 26, 60, 65, 96 success rate, 73, 74 Sudan, 8, 69 Sun, 115 supplementation, 92 surgical complications, 73, 74, 80, 88 surgical intervention, 2, 7, 16, 19, 31, 37, 88 surgical removal, 67 surgical technique, 113, 145 suture, 69, 106, 108, 119, 122 sweets eating, 87, 93 symptomology, 145 symptoms, 4, 6, 24, 36, 41, 48, 65, 66, 91, 98, 104, 106, 109, 122, 123, 131, 141 syndrome, 2, 4, 6, 106, 109, 110, 146 T T2DM, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 93, 97, 101, 109, 115 tachycardia, 27, 28, 31, 52 tachypnea, 27, 28, 31 target, 13, 14, 106 Task Force, 8, 69 teams, 90 techniques, 1, 24, 39, 43, 49, 96, 123, 142 testing, 3, 6 texture, 6 therapeutic change, 92 therapy, 11, 14, 21 time-frame, 26 tissue, 75, 101 total cholesterol, 14 transection, 94, 105, 111 transfusion, 31 trauma, 146 treatment, 2, 9, 10, 13, 14, 15, 16, 18, 19, 21, 28, 42, 50, 57, 58, 62, 66, 69, 70, 81, 93, 94, 105, 106, 109, 110, 113, 115, 118, 122, 130, 136, 140 tremor, 109 trial, 7, 21, 69, 70, 83, 112, 113, 118 triglycerides, 15 tumor, 109 twist, 102 type 2 diabetes, 9, 10, 20, 21, 93, 115 U ulcer, 6, 30, 36, 42, 47, 53, 94, 105, 106, 115, 117, 120, 121, 123, 137, 144 uniform, 35 United States (USA), 3, 10, 27 urbanization, 24 usual dose, 13 V vacuum, 119 valuation, 53, 115 valve, 97, 117, 130, 134, 146 variations, 88 vessels, 94 videos, 54 visualization, 105 vitamin A, 154 vitamins, 140 volvulus, 32 vomiting, 4, 28, 36, 42, 48, 75, 77 W water, 34, 37, 39 weight gain, 25, 33, 37, 43, 47, 145, 147 Index weight regain, 4, 7, 12, 14, 25, 32, 46, 59, 62, 65, 73, 74, 76, 77, 91, 92, 96, 97, 98, 113, 114, 117, 126, 127, 128, 134, 145, 149, 150, 151, 152, 154, 156 white blood cells, 51 withdrawal, 110 work absenteeism, 10 workstation, 39 167 worldwide, 23, 24, 25, 58, 83, 112 worry, 58 wound infection, 77 Y young adults, 118