Reconsideration of the Gastroparetic Syndrome.

PURPOSE OF REVIEW: Gastroparesis is a chronic disorder characterized by a constellation of foregut symptoms, including postprandial nausea, vomiting, distension, epigastric pain, and regurgitation in the absence of gastric outlet obstruction. Despite considerable research over the past decades, there remains to be only nominal understanding of disease classification, diagnostic criteria, pathogenesis, and preferred therapy. RECENT FINDINGS: We critically reassess current approaches for disease identification and stratification, theories of causation, and treatment for gastroparesis. Gastric scintigraphy, long considered a diagnostic standard, has been re-evaluated in light of evidence showing low sensitivity, whereas newer testing modalities are incompletely validated. Present concepts of pathogenesis do not provide a unified model linking biological impairments with clinical manifestations, whereas available pharmacological and anatomical treatments lack explicit selection criteria or evidence for sustained effectiveness. We propose a disease model that embodies the re-programming of distributed neuro-immune interactions in the gastric wall by inflammatory perturbants. These interactions, combined with effects on the foregut hormonal milieu and brain-gut axis, are postulated to generate the syndromic attributes characteristically linked with gastroparesis. Research linking models of immunopathogenesis with diagnostic and therapeutic paradigms will lead to reclassifications of gastroparesis that guide future trials and technological developments. KEY POINTS: • The term gastroparesis embodies a heterogenous array of symptoms and clinical findings based on a complex assimilation of afferent and efferent mechanisms, gastrointestinal locations, and pathologies. • There currently exists no single test or group of tests with sufficient capacity to be termed a definitional standard for gastroparesis. • Present research regarding pathogenesis suggests the importance of immune regulation of intrinsic oscillatory activity involving myenteric nerves, interstitial cells of Cajal, and smooth muscle cells. • Prokinetic pharmaceuticals remain the mainstay of management, although novel treatments are being studied that are directed to alternative muscle/nerve receptors, electromodulation of the brain-gut axis, and anatomical (endoscopic, surgical) interventions.

The impact of procedure type on 30-day readmissions following metabolic and bariatric surgery: postoperative complications of bariatric surgery.

BACKGROUND: Hospital readmission (HR) rates following metabolic/bariatric surgery (MBS) are used as a surrogate for quality outcomes and are increasingly tied to reimbursement rates. There are limited data concerning predictors of HR rates with regard to type of bariatric procedure. METHODS: This study is a retrospective review of prospectively collected data from patients who underwent MBS from January 2014 to December 2019 at Brigham and Women's Hospital in Boston, Massachusetts. The causes of all HRs and reoperations within 30 days of the original discharge were analyzed. Statistical significance was determined using Chi Squared test and T test. RESULTS: 2815 patients underwent MBS. 2373 patients (84.3%) had primary procedures, while 442 patients (15.7%) had secondary or revisional procedures. The overall 30-day readmission rate was 5.7%, with no significant difference for patients who underwent primary vs. secondary MBS. Among primary procedures, the readmission rate was higher for Roux-en-Y Gastric Bypass (RYGB) than laparoscopic sleeve gastrectomy (SG) (10.32% vs. 4.77%). Readmissions were most often due to nontechnical causes. The overall reoperation rate was 1.14% and was higher for patients undergoing secondary vs. primary procedures (2.94% vs 0.80%). CONCLUSIONS: Readmission rate was similar to that in existing literature. Revisional/secondary surgery did not lead to increased readmissions, although was associated with a higher reoperation rate. Most HRs were due to nontechnical causes. Optimization of postoperative care, such as fluid status, may reduce the incidence of postoperative complications.

The first modified Delphi consensus statement on sleeve gastrectomy.

INTRODUCTION: Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG. METHODS: We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus. RESULTS: The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE. CONCLUSION: A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic.

The first consensus statement on revisional bariatric surgery using a modified Delphi approach.

BACKGROUND: Revisional bariatric surgery (RBS) constitutes a possible solution for patients who experience an inadequate response following bariatric surgery or significant weight regain following an initial satisfactory response. This paper reports results from the first modified Delphi consensus-building exercise on RBS. METHODS: We created a committee of 22 recognised opinion-makers with a special interest in RBS. The committee invited 70 RBS experts from 27 countries to vote on 39 statements concerning RBS. An agreement amongst ≥ 70.0% experts was regarded as a consensus. RESULTS: Seventy experts from twenty-seven countries took part. There was a consensus that the decision for RBS should be individualised (100.0%) and multi-disciplinary (92.8%). Experts recommended a preoperative nutritional (95.7%) and psychological evaluation (85.7%), endoscopy (97.1%), and a contrast series (94.3%). Experts agreed that Roux-Y gastric bypass (RYGB) (94.3%), One anastomosis gastric bypass (OAGB) (82.8%), and single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) (71.4%) were acceptable RBS options after gastric banding (84.3%). OAGB (84.3%), bilio-pancreatic diversion/duodenal switch (BPD/DS) (81.4%), and SADI-S (88.5%) were agreed as consensus RBS options after sleeve gastrectomy. lengthening of bilio-pancreatic limb was the only consensus RBS option after RYGB (94.3%) and OAGB (72.8%). CONCLUSION: Experts achieved consensus on a number of aspects of RBS. Though expert opinion can only be regarded as low-quality evidence, the findings of this exercise should help improve the outcomes of RBS while we develop robust evidence to inform future practice.

Low Incidence of Postoperative Leaks When Using Small-Diameter Calibrated Bougies During Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is a well-established bariatric procedure. A staple line leak is a recognized complication of LSG. Bougie size has been suggested to impact leak rates. In this study, we evaluate the impact of using 32-34F bougie sizes with LSG on early postoperative outcomes including staple line leaks within our practice. METHODS: This is a retrospective cohort analysis of a prospectively maintained database of all LSG procedures performed between January 2012 and December 2018 at a single medical center. Data collected and analyzed included bougie size, postoperative leak rate, need for re-operation, 12-month excess weight loss, and 30-day morbidity and mortality. RESULTS: During the study period, 3153 patients underwent LSG, of whom 1977 (62.7%) were female. Mean age and body mass index (BMI) were 42.9 ± 12.2 years (range 15-76 years) and 42.4 ± 5.2 kg/m2 (range 27-73), respectively. No intraoperative complications or mortality occurred. There was one case of perioperative mortality due to bleeding (0.03%). Early postoperative adverse events occurred in 131 patients (4.1%): 17 leaks (0.5%), 75 bleeds (2.4%), and 39 (1.2%) other. CONCLUSION: The use of smaller-sized (32-34F) bougies had no impact on staple line leaks in the hands of experienced bariatric surgeons at a high-volume center.

Safety and efficacy of single-stage conversion of failed adjustable gastric band to laparoscopic Roux-en-Y gastric bypass: a case-control study.

BACKGROUND: We conducted the following study to evaluate the safety and efficacy of single-stage conversion of failed laparoscopic adjustable gastric band (LAGB) to laparoscopic Roux-en-Y gastric bypass (LRYGB) as compared to a cohort of primary LRYGB patients. METHODS: A single-institution, prospectively maintained bariatric database was used to retrospectively identify consecutive patients who underwent single-stage removal of LAGB with concomitant conversion to LRYGB between the years of 2007 and 2013. The study cohort was matched 1:1 for age, gender, body mass index (BMI), and approximate date of operation to patients who underwent primary LRYGB. Primary endpoints were operative time, complication rate, length of hospital stay (LOS), and percent excess BMI lost (%EBMIL) at 24-month follow-up. RESULTS: Ninety-four conversion patients met inclusion criteria. There were no statistically significant differences in the mean LOS (3.1 vs. 3.0 days, p = 0.97) or the major complication rate (3.2 vs. 1.1 %, p = 0.62) at 30 days postoperatively. Likewise, 30-day minor complication rates, including readmission, were similar between groups (7.5 vs. 6.4 %, p = 0.77). The average operative time was significantly longer for conversion compared to primary LRYGB (193.5 vs. 132 min; p < 0.01). At most recent follow-up after conversion or primary LRYGB, median %EBMIL was 61.3 and 77.3 % (p < 0.01), percent total weight loss was 23.6 and 30.5 % (p < 0.01), and percent change in BMI was 23.4 and 30.5 % (p < 0.01), respectively. Median follow-up time was 17 and 18.6 months after conversion and primary LRYGB, respectively. CONCLUSION: Single-stage conversion of LAGB to LRYGB is safe with an acceptable complication rate and similar LOS compared to primary LRYGB.

Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

Current recommendations for procedure selection in class I and II obesity developed by an expert modified Delphi consensus.

Metabolic and bariatric surgery (MBS) is widely considered the most effective option for treating obesity, a chronic, relapsing, and progressive disease. Recently, the American Society of Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) issued new guidelines on the indications for MBS, which have superseded the previous 1991 National Institutes of Health guidelines. The aim of this study is to establish the first set of consensus guidelines for selecting procedures in Class I and II obesity, using an Expert Modified Delphi Method. In this study, 78 experienced bariatric surgeons from 32 countries participated in a two-round Modified Delphi consensus voting process. The threshold for consensus was set at an agreement or disagreement of ≥ 70.0% among the experts. The experts reached a consensus on 54 statements. The committee of experts reached a consensus that MBS is a cost-effective treatment option for Class II obesity and for patients with Class I obesity who have not achieved significant weight loss through non-surgical methods. MBS was also considered suitable for patients with Type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30 kg/m2 or higher. The committee identified intra-gastric balloon (IGB) as a treatment option for patients with class I obesity and endoscopic sleeve gastroplasty (ESG) as an option for patients with class I and II obesity, as well as for patients with T2DM and a BMI of ≥ 30 kg/m2. Sleeve gastrectomy (1) and Roux-en-Y gastric bypass (RYGB) were also recognized as viable treatment options for these patient groups. The committee also agreed that one anastomosis gastric bypass (OAGB) is a suitable option for patients with Class II obesity and T2DM, regardless of the presence or severity of obesity-related medical problems. The recommendations for selecting procedures in Class I and II obesity, developed through an Expert Modified Delphi Consensus, suggest that the use of standard primary bariatric endoscopic (IGB, ESG) and surgical procedures (SG, RYGB, OAGB) are acceptable in these patient groups, as consensus was reached regarding these procedures. However, randomized controlled trials are still needed in Class I and II Obesity to identify the best treatment approach for these patients in the future.

Metabolic and Bariatric Surgeon Criteria-An International Experts' Consensus.

PURPOSE: With the global epidemic of obesity, the importance of metabolic and bariatric surgery (MBS) is greater than ever before. Performing these surgeries requires academic training and the completion of a dedicated fellowship training program. This study aimed to develop guidelines based on expert consensus using a modified Delphi method to create the criteria for metabolic and bariatric surgeons that must be mastered before obtaining privileges to perform MBS. METHODS: Eighty-nine recognized MBS surgeons from 42 countries participated in the Modified Delphi consensus to vote on 30 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus. RESULTS: Consensus was reached on 29 out of 30 statements. Most experts agreed that before getting privileges to perform MBS, surgeons must hold a general surgery degree and complete or have completed a dedicated fellowship training program. The experts agreed that the learning curves for the various operative procedures are approximately 25-50 operations for the LSG, 50-75 for the OAGB, and 75-100 for the RYGB. 93.1% of experts agreed that MBS surgeons should diligently record patients' data in their National or Global database. CONCLUSION: MBS surgeons should have a degree in general surgery and have been enrolled in a dedicated fellowship training program with a structured curriculum. The learning curve of MBS procedures is procedure dependent. MBS surgeons must demonstrate proficiency in managing postoperative complications, collaborate within a multidisciplinary team, commit to a minimum 2-year patient follow-up, and actively engage in national and international MBS societies.

Revision/Conversion Surgeries After One Anastomosis Gastric Bypass-An Experts' Modified Delphi Consensus.

PURPOSE: There is a lack of evidence for treatment of some conditions including complication management, suboptimal initial weight loss, recurrent weight gain, or worsening of a significant obesity complication after one anastomosis gastric bypass (OAGB). This study was designed to respond to the existing lack of agreement and to provide a valuable resource for clinicians by employing an expert-modified Delphi consensus method. METHODS: Forty-eight recognized bariatric surgeons from 28 countries participated in the modified Delphi consensus to vote on 64 statements in two rounds. An agreement/disagreement among ≥ 70.0% of the experts was regarded to indicate a consensus. RESULTS: A consensus was achieved for 46 statements. For recurrent weight gain or worsening of a significant obesity complication after OAGB, more than 85% of experts reached a consensus that elongation of the biliopancreatic limb (BPL) is an acceptable option and the total bowel length measurement is mandatory during BPL elongation to preserve at least 300-400 cm of common channel limb length to avoid nutritional deficiencies. Also, more than 85% of experts reached a consensus on conversion to Roux-en-Y gastric bypass (RYGB) with or without pouch downsizing as an acceptable option for the treatment of persistent bile reflux after OAGB and recommend detecting and repairing any size of hiatal hernia during conversion to RYGB. CONCLUSION: While the experts reached a consensus on several aspects regarding revision/conversion surgeries after OAGB, there are still lingering areas of disagreement. This highlights the importance of conducting further studies in the future to address these unresolved issues.

2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery.

MAJOR UPDATES TO 1991 NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR BARIATRIC SURGERY: Metabolic and bariatric surgery (MBS) is recommended for individuals with a body mass index (BMI) >35 kg/m2, regardless of presence, absence, or severity of co-morbidities.MBS should be considered for individuals with metabolic disease and BMI of 30-34.9 kg/m2.BMI thresholds should be adjusted in the Asian population such that a BMI >25 kg/m2 suggests clinical obesity, and individuals with BMI >27.5 kg/m2 should be offered MBS.Long-term results of MBS consistently demonstrate safety and efficacy.Appropriately selected children and adolescents should be considered for MBS.(Surg Obes Relat Dis 2022; https://doi.org/10.1016/j.soard.2022.08.013 ) © 2022 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Concomitant Cholecystectomy for Asymptomatic Gallstones in Bariatric Surgery-Safety Profile and Feasibility in a Large Tertiary Referral Bariatric Center.

BACKGROUND: Obesity is a risk factor for gallstone formation, which can be exacerbated by bariatric surgery-induced rapid weight loss. Current guidelines do not recommend concomitant cholecystectomy (CC) for asymptomatic gallstones during the bariatric surgery procedure. However, long-term follow-up studies have shown that the incidence of post-bariatric surgery symptomatic gallstones necessitating therapeutic cholecystectomy increases to 40%. Therefore, some surgeons advocate simultaneous cholecystectomy during the bariatric surgery for asymptomatic individuals. This study aims to evaluate the safety of performing cholecystectomy for asymptomatic gallstones during the bariatric procedure. METHODS: Data from a consecutive series of patients that underwent primary laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB) or conversion of LSG to a LRYGB with or without concomitant cholecystectomy for asymptomatic gallstones between Jan 2010 and Dec 2017 were retrieved from the database. The primary endpoint was the complication rate. Secondary endpoints were the surgical operating room time (ORT) and the length of hospital stay (LOS). RESULTS: Out of the 2828 patients who were included, 120 patients underwent a concomitant cholecystectomy during their bariatric procedure (LSG or LRYGB) for asymptomatic gallbladder stones and were compared to the 2708 remaining patients who only had bariatric surgery. None of the concomitant cholecystectomy patients developed a gallbladder-related complication. There was no significant increase in the rate of minor or major complications between the CC groups and the non-CC groups (LSG: 6.7% vs. 3.2%, p=0.132; LRYGB: 0% vs. 2.3%, p =0.55; and conversion of LSG to LRYGB: 20% vs. 7.1%, p = 0.125, respectively). In addition, there was no significant increase in the length of hospital stay (1.85 ±4.19 days vs. 2.24 ±1.82, p=0.404) for LSG group and (1.75 ±2.0 vs. 2.3 ±2.1, p=0.179) for LRYGB group. Adding the cholecystectomy to the bariatric procedure only added an average of 23 min (min) (27 min when added to LSG and 18 min when added to LRYGB). CONCLUSION: As one of the largest series reviewing concomitant cholecystectomy in bariatric surgery, this study showed that in skilled laparoscopic bariatric surgical hands, concomitant cholecystectomy during bariatric surgery is safe and prevents potential future gallstone-related complications. Long-term large prospective randomized trials are needed to further clarify the recommendation of prophylactic concomitant cholecystectomy during bariatric surgery.

2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery.

Major updates to 1991 National Institutes of Health guidelines for bariatric surgery.

Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for type 2 diabetes remission (ORDER): protocol of a multicentre, randomised controlled, open-label, superiority trial.

INTRODUCTION: Previous studies have demonstrated that one anastomosis gastric bypass (OAGB) is not inferior to Roux-en-Y gastric bypass (RYGB) in treating obesity. However, high level evidence comparing the efficacy and safety of both procedures in type 2 diabetes (T2D) treatment is still lacking, which is another main aim of bariatric surgery. The presented trial has been designed to aim at investigating the superiority of OAGB over the reference procedure RYGB in treating T2D as primary endpoint. And diabetes-related microvascular and macrovascular complications, cardiovascular comorbidities, weight loss, postoperative nutritional status, quality of life and overall complications will be followed up for 5 years as secondary endpoints. METHODS AND ANALYSIS: This prospective, multicentre, randomised superiority open-label trial will be conducted in patients of Asian descent. A total of 248 patients (BMI≥27.5 kg/m2) who are diagnosed with T2D will be randomly assigned (1:1) to OAGB or RYGB with blocks of four. The primary endpoint is the complete diabetes remission rate defined as HbA1c≤6.0% and fasting plasma glucose≤5.6 mmol/L without any antidiabetic medications at 1 year after surgery. All secondary endpoints will be measured at different follow-up visit points, which will start at least 3 months after enrolment, with a continuous annual follow-up for five postoperative years in order to provide solid evidence on the efficacy and safety of OAGB in patients with T2D. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of leading centre (Beijing Friendship Hospital, Capital Medical University, no. 2021-P2-037-03). The results generated from this work will be disseminated to academic audiences and the public via publications in international peer-reviewed journals and conferences. The data presented will be imported into a national data registry. Findings are expected to be available in 2025, which will facilitate clinical decision-making in the field. TRIAL REGISTRATION NUMBER: NCT05015283.

The First Modified Delphi Consensus Statement for Resuming Bariatric and Metabolic Surgery in the COVID-19 Times.

The purpose of this study was to achieve consensus amongst a global panel of expert bariatric surgeons on various aspects of resuming Bariatric and Metabolic Surgery (BMS) during the Coronavirus Disease-2019 (COVID-19) pandemic. A modified Delphi consensus-building protocol was used to build consensus amongst 44 globally recognised bariatric surgeons. The experts were asked to either agree or disagree with 111 statements they collectively proposed over two separate rounds. An agreement amongst ≥ 70.0% of experts was construed as consensus as per the predetermined methodology. We present here 38 of our key recommendations. This first global consensus statement on the resumption of BMS can provide a framework for multidisciplinary BMS teams planning to resume local services as well as guide future research in this area.

Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial.

BACKGROUND: To compare implantable gastric stimulation therapy with a standard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss (EWL) between the control and treatment groups. The primary endpoint was the percentage of EWL from baseline to 12 months after randomization. Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients; however, previous investigations have reported inconclusive results. METHODS: A total of 190 subjects were enrolled in this prospective, randomized, placebo-controlled, double-blind, multicenter study. All patients underwent implantation with the implantable gastric stimulator and were randomized to 1 of 2 treatment groups: the control group (stimulation off) or treatment group (stimulation on). The patients were evaluated on a monthly basis. All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings. RESULTS: The procedure resulted in no deaths and a low complication rate. The primary endpoint of a difference in weight loss between the treatment and control groups was not met. The control group lost 11.7% +/- 16.9% of excess weight and the treatment group lost 11.8% +/- 17.6% (P = .717) according to an intent-to-treat analysis. CONCLUSION: Implantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations. However, the results of the present study do not support its application. Additional research is indicated to understand the physiology and potential benefits of this therapy.

Revision of Roux-en-Y Gastric Bypass with Limb Distalization for Inadequate Weight Loss or Weight Regain.

BACKGROUND: Of patients undergoing Roux-en-Y gastric bypass (RYGB), 15-35% of patients fail to achieve "adequate" weight loss or regain significant weight. Multiple solutions have been proposed, but not well studied. We report our experience with limb distalization with lengthening the biliopancreatic (BP) limb and shortening the common channel (CC). METHODS: We retrospectively reviewed data from patients undergoing laparoscopic limb distalization for excess weight loss (EWL) <50% or BMI >35 kg/m2 after RYGB from 2012 to 2017. The BP limb was lengthened and CC was shortened to 100-200 cm. Perioperative outcomes such as morbidity, weight loss, nutritional deficiencies, comorbidity remission, and operative details were analyzed. RESULTS: Twenty-two patients were included. The mean BMI prior to RYGB was 54.1 ± 8.5 kg/m2 and 43.0 ± 5.5 kg/m2 prior to limb distalization. The mean follow-up was 18.3 ± 12.9 months with a mean BMI change, %EWL, and %TWL (total weight loss) of 11.8 ± 7.4 kg/m2, 62.3 ± 32.4%, and 25.4 ± 14.4%, respectively. The total mean BMI change, %EWL, and %TWL from RYGB was 22.2 ± 9.9 kg/m2, 77.8 ± 23.6%, and 40.2 ± 13.3%, respectively. Of patients with persistent comorbidities, remission rates of diabetes, hypertension, and gastroesophageal reflux disease were 100%, 17%, and 38%, respectively. The mean operative time was 132.6 ± 54.4 min and mean hospital stay was 2.2 ± 1.3 days. Overall morbidity was 27.3%. Three patients (13.6%) developed nutritional deficiencies requiring reversal surgery. CONCLUSION: In patients with inadequate weight loss or weight regain after RYGB, limb distalization with lengthening of the BP limb is an effective procedure for additional weight loss and further improvement of comorbidities. Nutritional complications are a risk, but can be minimized with close follow-up and patient compliance.

Laparoscopic sleeve gastrectomy--volume and pressure assessment.

BACKGROUND: Aiming to clarify the mechanism of weight loss after the restrictive bariatric procedure of sleeve gastrectomy (LSG), the volumes and pressures of the stomach, of the removed part, and of the remaining sleeve were measured in 20 morbidly obese patients. METHODS: The technique used consisted of occlusion of the pylorus with a laparoscopic clamp and of the gastroesophageal junction with a special orogastric tube connected to a manometer. Instillation of methylene-blue-colored saline via the tube was continued until the intraluminal pressure increased sharply, or the inflated stomach reached 2,000 cc. After recording of measurements, LSG was performed. RESULTS: Mean volume of the entire stomach was 1,553 cc (600-2,000 cc) and that of the sleeve 129 cc (90-220 cc), i.e., 10% (4-17%) and that of the removed stomach was 795 cc (400-1,500 cc). The mean basal intragastric pressure of the whole stomach after insufflations of the abdominal cavity with CO(2) to 15 mmHg was 19 mmHg (11-26 mmHg); after occlusion and filling with saline it was 34 mmHg (21-45 mmHg). In the sleeved stomach, mean basal pressure was similar 18 mmHg (6-28 mmHg); when filled with saline, pressure rose to 43 mmHg (32-58 mmHg). The removed stomach had a mean pressure of 26 mmHg (12-47 mmHg). There were no postoperative complications and no mortality. CONCLUSIONS: The notably higher pressure in the sleeve, reflecting its markedly lesser distensibility compared to that of the whole stomach and of the removed fundus, indicates that this may be an important element in the mechanism of weight loss.

Comparison of permanent and nonpermanent staple line buttressing materials for linear gastric staple lines during laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: Several publications have suggested that staple line buttressing might decrease staple line bleeding, increase burst pressure, and decrease the likelihood of acute failure resulting in leak. Currently, permanent and nonpermanent options are available. However, concern has been raised about the permanent buttress material and its potential for delayed strip expulsion. This study analyzed our experience with 3 different buttressing materials for creating the gastric division during laparoscopic Roux-en-Y gastric bypass. METHODS: From July 5, 2001 to May 30, 2007, 1451 consecutive patients underwent laparoscopic gastric bypass with buttressing material used for the stapled creation of the gastric pouch. Peristrips Dry (PSDs), permanent bovine pericardial strips, were used in 926 cases from July 5, 2001 to October 11, 2005. Seamguards, a synthetic bioabsorbable product, were used in 145 cases from November 2, 2004 to July 18, 2006, and PSD Veritas, remodelable, nonpermanent bovine pericardial strips, were placed in 380 patients from October 11, 2005 to May 30, 2007. All products were applied to the 60-mm-long, 3.5-mm cartridges of the EndoGIA II stapler. The ease of use, operative complications, visual bleeding, and postoperative leaks were recorded. RESULTS: The patient characteristics were comparable for all groups. All products were easy to load on the stapler, and no operative complications related to the use of the buttress materials occurred. The incidence and severity of staple line bleeding was not specifically calculated but was visually noted to be minimal in all cases. Of the 3 groups, 4 contained leaks occurred in the Seamguards group, and all were successfully managed nonoperatively. No acute leaks were discovered in the PSD or PSD Veritas groups. This difference was statistically significant (p <.001). CONCLUSION: Neither the PSDs or PSD Veritas group exhibited staple line complications. However, 4 leaks occurred in the patients who had Seamguards incorporated into their gastric pouch linear staple lines.