Prospective evaluation of transoral outlet reduction (TORe) after Roux-en-Y gastric bypass (RYGB) failure.

BACKGROUND AND AIMS: Weight regain after RYGB is multifactorial including dilatation of the gastro-jejunal anastomosis. Transoral outlet reduction (TORe) procedure is a minimally invasive alternative to surgical anastomotic revision. METHODS: We conducted a prospective, multicenter, simple blind, randomized study in patients with weight regain following RYGB, comparing the efficacy of conventional nutritional and behavioral management associated with a TORe procedure (TORe group) with conventional management alone and a Sham procedure (Sham group). The main objective of this study was to evaluate the percentage of excess weight loss (%EWL) at 12 months after endoscopy. RESULTS: From January 2015 to January 2019, 73 subjects were randomized in four French Bariatric centers. The final analysis involved 50 subjects, 25 in each group, 44 women, 6 men, with an average BMI of 40.6 kg/m2. At 12 months, the average %EWL was significantly higher in the TORe group than in the Sham group (13.5 ± 14.1 vs. - 0.77 ± 17.1; p = 0.002). Cohen's d was 0.91, indicating a large effect size of the procedure on the %EWL. There was no significant difference between groups concerning the improvement of obesity-related comorbidities (diabetes and dyslipidemia) and quality of life at 12 months. We report frequent adverse events in the TORe group (20% had adverse events related to the procedure). Three adverse events were serious, including two perforations of the gastro-jejunal anastomosis after TORe group that led to the premature termination of the study. CONCLUSIONS: After RYGBP failure linked to the dilatation of the gastro-jejunal anastomosis, TORe procedure with nutritional management results in significantly higher %EWL at 12 months compared to patients with nutritional management alone. As surgery, this minimally invasive endoscopic procedure can be associated with severe adverse events.

Impact of Robotic Assistance on Complications in Bariatric Surgery at Expert Laparoscopic Surgery Centers: A Retrospective Comparative Study With Propensity Score.

OBJECTIVE: To investigate the way robotic assistance affected rate of complications in bariatric surgery at expert robotic and laparoscopic surgery facilities. BACKGROUND: While the benefits of robotic assistance were established at the beginning of surgical training, there is limited data on the robot's influence on experienced bariatric laparoscopic surgeons. METHODS: We conducted a retrospective study using the BRO clinical database (2008-2022) collecting data of patients operated on in expert centers. We compared the serious complication rate (defined as a Clavien score≥3) in patients undergoing metabolic bariatric surgery with or without robotic assistance. We used a directed acyclic graph to identify the variables adjustment set used in a multivariable linear regression, and a propensity score matching to calculate the average treatment effect (ATE) of robotic assistance. RESULTS: The study included 35,043 patients [24,428 sleeve gastrectomy (SG); 10,452 Roux-en-Y gastric bypass (RYGB); 163 single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S)], with 938 operated on with robotic assistance (801 SG; 134 RYGB; 3 SADI-S), among 142 centers. Overall, we found no benefit of robotic assistance regarding the risk of complications (average treatment effect=-0.05, P =0.794), with no difference in the RYGB+SADI group ( P =0.322) but a negative trend in the SG group (more complications, P =0.060). Length of hospital stay was decreased in the robot group (3.7±11.1 vs 4.0±9.0 days, P <0.001). CONCLUSIONS: Robotic assistance reduced the length of stay but did not statistically significantly reduce postoperative complications (Clavien score≥3) following either GBP or SG. A tendency toward an elevated risk of complications following SG requires more supporting studies.

Best practice approach for redo-surgeries after sleeve gastrectomy, an expert's modified Delphi consensus.

BACKGROUND: Sleeve gastrectomy (SG) is the most common metabolic and bariatric surgical (MBS) procedure worldwide. Despite the desired effect of SG on weight loss and remission of obesity-associated medical problems, there are some concerns regarding the need to do revisional/conversional surgeries after SG. This study aims to make an algorithmic clinical approach based on an expert-modified Delphi consensus regarding redo-surgeries after SG, to give bariatric and metabolic surgeons a guideline that might help for the best clinical decision. METHODS: Forty-six recognized bariatric and metabolic surgeons from 25 different countries participated in this Delphi consensus study in two rounds to develop a consensus on redo-surgeries after SG. An agreement/disagreement ≥ 70.0% on statements was considered to indicate a consensus. RESULTS: Consensus was reached for 62 of 72 statements and experts did not achieve consensus on 10 statements after two rounds of online voting. Most of the experts believed that multi-disciplinary team evaluation should be done in all redo-procedures after SG and there should be at least 12 months of medical and supportive management before performing redo-surgeries after SG for insufficient weight loss, weight regain, and gastroesophageal reflux disease (GERD). Also, experts agreed that in case of symptomatic GERD in the presence of adequate weight loss, medical treatment for at least 1 to 2 years is an acceptable option and agreed that Roux-en Y gastric bypass is an appropriate option in this situation. There was disagreement consensus on efficacy of omentopexy in rotation and efficacy of fundoplication in the presence of a dilated fundus and GERD. CONCLUSION: Redo-surgeries after SG is still an important issue among bariatric and metabolic surgeons. The proper time and procedure selection for redo-surgery need careful considerations. Although multi-disciplinary team evaluation plays a key role to evaluate best options in these situations, an algorithmic clinical approach based on the expert's consensus as a guideline can help for the best clinical decision-making.

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.

Reducing greenhouse gas emissions in a bariatric surgical unit is a complex but feasible project.

Obesity is a growing issue worldwide, whose causes and consequences are linked to the environment and which therefore has a high carbon footprint. On the other hand, obesity surgery, along with other procedures in surgical suites, entails environmental consequences and responsibilities. We conducted a prospective comparative study on two groups of bariatric interventions (N = 59 and 56, respectively) during two consecutive periods of time (Oct 2021-March 2022), first without and then with specific measures aimed at reducing greenhouse gas emissions related to bariatric procedures by approximately 18%. These measures included recycling of disposable surgical equipment, minimizing its use, and curbing anesthetic gas emissions. Further and continuous efforts/incentives are warranted, including reframing the surgical strategies. Instead of comparing measurements, which is difficult at the present time, we suggest defining an ECO-SCORE in operating rooms, among other healthcare facilities.

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.

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.

Correction to: The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

This article was originally published electronically on the publisher's internet portal on May 5, 2020 without open access.

The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

PURPOSE: The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population. MATERIALS AND METHODS: Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications. RESULTS: Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m2. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically). CONCLUSION: The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters.

Correction to: The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients.

An author name was incorrectly indicated in the Conflict of Interest Statement.

Lap banding as a redo surgery: "restriction over restriction" may be a relevant bariatric strategy.

BACKGROUND: The redo issue is a growing and debated issue in bariatric surgery. From the experience of failed vertical banded gastroplasty (VBG), we suggest that adjustable gastric band is a relevant method in many cases. METHODS: Ninety-eight patients have been operated on in a 13-year period (07/1995-07/2008). The cause of VBG failure has been staple disruption in 58% of cases and an outlet enlargement in 37% of cases. In the meantime, two gastric bypasses have been performed. Mean body mass index has been 38 (28-48) and was less than 35 in 37% of the cases. RESULTS: Postoperative complications occurred in seven cases, and the band had to be removed in five cases. Mean excess weight loss has been 52% at 8 years, yet 22% of the patients have been lost for follow-up. Slippage occurred in two patients and erosion in one. A final removal of the band has been necessary in two patients. CONCLUSIONS: VBG failures are highly common in the long run. Lap banding represents an interesting option for redo in a majority of cases, providing good long-term results and demonstrating that "restriction over restriction" can be a relevant strategy. The initial response to VBG has been a key information: if it has been successful in terms of weight loss and food tolerance, then lap banding was a valuable option. VBG has represented an interesting model because it has historical value and could be a procedure for the future if performed through endoscopic channels.

Isolated food intolerance after adjustable gastric banding: a major cause of long-term band removal.

BACKGROUND: Erosion, slippage, and esophageal dilatation have been acknowledged as typical long-term issues after lap banding. Yet it seems from our experience that isolated food intolerance has become a leading cause for band removal, although not reported as such in the literature. METHODS: There were 1,450 patients who have been operated on over 12 years (May 1995-May 2007). Food intolerance occurred in 41 cases (2.9%), representing 1/3 of the causes of band removal. The average time for diagnosis was 58 months (16-110). Seventeen cases occurred before 5 years of follow-up, and 25 after. RESULTS: The postoperative course has been uneventful in all cases of simple removal. No patient had re-banding after removal, one had vertical banded gastroplasty in another center, two a gastric bypass, one a BPD, and four had a sleeve gastrectomy at the same operative time as band removal. Food intolerance is rarely reported in the literature, or often attributed to "poor compliance" or "poor results" after lap banding. The background and symptoms of this entity should be separated from other issues, i.e., esophageal dilatation and band slippage. Gastric bypass is a valuable option after band removal, but like others, we prefer sleeve gastrectomy as a second step procedure, given the weight loss that has already been achieved in many cases. CONCLUSION: Food intolerance after lap-banding is likely to represent the most common cause for band removal in the long run, although we do not know its future rate. From the literature and our experience, there is no clear cause to this complication in the majority of the cases; neither the type of band nor the type of procedure are sufficient explanations.

The patient barrier to growth of bariatric surgery: another French paradox?

The bariatric surgery community is complaining about the multiple barriers that hamper the growth of procedures that have been found to be the only effective treatment for morbid obesity. The French situation demonstrates that the number of procedures has stabilized after a period of rapid growth, despite the facts that the needs are not satisfied and that there are less important barriers to surgery than in most countries. This new "French paradox" is understandable if one accepts the reluctance of the public audience and an insufficient level of evidence for a systematic referral to bariatric surgery. Less invasive procedures should make it possible to re-unify the physicians who deal with obesity, as well as the implementation of comparatives and randomized clinical studies.

Laparoscopic Gastric Banding: Game Over?

The laparoscopic adjustable gastric banding (LAGB) procedure has been used in bariatric surgery for over 20 years, and despite its initial success, it has been most often criticized for causing adverse effects, lacking efficacy, and frequently requiring revision. Evidence-based medicine supports these criticisms, and the LAGB is no longer considered by most bariatric surgeons worldwide to be a standard operation. While we have to admit that its associated food tolerance issues and variable efficacy make the LAGB less desirable for most patients, time will tell whether the current armamentarium of bariatric procedures are still too aggressive and new safer procedures still need to be developed.

Novel Endoscopic Management of Obesity.

Endoscopic procedures have been well-documented in the obesity field, but have not yet reached a sufficient level of evidence as stand-alone methods for treating obesity. It is unclear if they should take over. Although expanding, the array of bariatric surgical techniques does not fully meet the current needs, and there are not enough resources for increasing surgery. Surgery is avoided by a majority of patients, so that less aggressive procedures are necessary. For the time being, relevant endoscopic methods include intra-gastric balloons, gastric partitioning (Endo-plication), and the metabolic field (Endo-barrier). Surgical novelties and basic research are also important contributors owing to their potential combination with endoscopy. Conditions have been listed for implementation of bariatric endoscopy, because innovation is risky, expensive, and faces ethical challenges. A scientific background is being built (e.g., hormonal studies). Some techniques require additional study, while others are not ready but should be priorities. Steps and goals include the search for conceptual similarities and the respect of an ethical frame. Minimally invasive bariatric techniques are not ready for prime time, but they are already being successful as re-do procedures. A time-frame for step-strategies can be defined, and more investments from the industry are mandatory.

Esophageal dilatation after laparoscopic adjustable gastric banding: definition and strategy.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has become a method of choice worldwide to treat morbid obesity. Long-term complications such as esophageal dilatation require that a relevant strategy for treatment be defined. Esophageal dysmotility is commonly described in morbidly obese patients. METHODS: 1,232 patients have undergone LAGB over 9 years (1995-2004), and 162 (13.1%) have had a reoperation for complications (excluding access-port problems): slippage (109), erosion (28), intolerance (25). 80 patients (6.4%) had their band removed, and 10 had a switch to another procedure. Esophageal dilatation has been an isolated cause for removal in 2 patients and an associated cause in 6 patients. RESULTS: There was no significant correlation between esophageal dilatation and insufficient excess weight loss (<25%) after 5 years (37/257:14.3%). 4 stages of dilatation were identified, with the relevant treatment for each, the ultimate alternative being conversion to a laparoscopic gastric bypass. We suggest that esophageal dilatation be a separate issue from pouch dilatation and gastric erosion, and that it be classified as a complication only in severe cases requiring band removal. Most cases can be handled through deflation of the band under radiological control. CONCLUSION: LAGB can lead to significant esophageal troubles which must remain under scrutiny but generally respond to "radiological management", which also makes LAGB more demanding than other operations in terms of follow-up.

Multicenter Randomized Study of Obesity Treatment with Minimally Invasive Injection of Hyaluronic Acid Versus and Combined with Intragastric Balloon.

BACKGROUND: Research into minimally invasive techniques is worthwhile for greater acceptance in bariatric surgery, a useful first step being to evaluate the combination of these with current procedures. We suggest that intragastric balloon (IGB) can be performed with hyaluronic acid (HA) injections at the level of the gastroesophageal junction. METHODS: A submucosal restriction is created by circular injection of an absorbable material within a defined area based on endoscopic anatomy. We included 101 patients in a prospective multicenter randomized trial, with average body mass index (BMI) 33.4 (range 27-44), treated from April 2010 to April 2012 by IGB and/or HA injection, sequentially, and followed for two more years. Patients were divided into group 1 (IGB alone), group 2 (IGB followed by HA at IGB removal, at 6 months), and group 3 (HA and IGB at 6 months). RESULTS: BMI loss at 6 months was inferior in the HA group (32 patients) compared with the IGB groups (68 patients) (2.1 ± 0.4 versus 3.4 ± 0.3, p < 0.05). The efficacy of IGB alone compared with combined treatments (groups 2 and 3) was significantly inferior at 18 months only, but the impact of the treatment sequence (HA before or after IGB) on BMI loss was not statistically significant, although in favor of HA first. CONCLUSIONS: This study did not demonstrate the efficacy of HA injections as an obesity treatment.

Surgical treatment of morbid obesity by adjustable gastric band: the case for a conservative strategy in the case of failure - a 9-year series.

BACKGROUND: Lapaparoscopic adjustable gastric banding (LAGB) has become a widespread method to treat morbid obesity. Long-term complications and failures require a strategy for reoperation. METHODS: 1,180 patients have been operated on from April 1995 to December 2003. 151 had reoperation for complications (12.7%) excluding access-port problems: slippage (105), erosion (22), intolerance (24). 67 patients (5.6%) had their band removed; only 5 had a switch to another procedure. Esophageal dilatation and insufficient excess weight loss (<25%) after 5 years (13.7%) should also be addressed. Two situations are described: 1) Band in place: anterior slip, dilatation, isolated insufficient weight loss. 2) Band to be removed: posterior slip, severe anterior slip (acute, with necrosis or perforation), erosion, intolerance. Four options are recognized: 1) Conservation (adjustment management) or surgical correction (anterior slip). 2) Placement of a new band: for failure of the device, accidental removal (slippage in difficult conditions), and erosion after a delay. 3) RYGBP or BPD in selected cases only. 4) Other procedures. CONCLUSION: 1) A new band can be placed if there has been a technical problem. 2) Weight control is possible, including in the case of esophageal dilatation. Reoperation for insufficient weight loss without a technical problem is not an option. Failures of VBG cannot be fairly compared with Lap-Band (R) failures because of adjustability. 3) Reoperation is not often demanded. For failure after LAGB, the future should involve less invasive bariatric procedures and nonsurgical approaches.

Pouch dilatation and slippage after adjustable gastric banding: is it still an issue?

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) in France is currently the most common bariatric surgical procedure for the treatment of severe obesity; its most reported complication is band slippage and/or pouch dilatation, which usually requires reoperation. It is highly important to assess whether a change in the operation could improve these results. METHODS: From April 1995 to October 2001, 973 patients underwent LAGB in our institution. Since January 1999, our technique changed: the band was positioned according to the so called "pars flaccida technique", ie. around the gastric vessel instead of close to the gastric wall. 511 patients had been operated before this period, and 462 after. Other details in the technique did not change (dissection above the lesser sac, no posterior stitch, three anterior stitches), meaning that potential differences could not be related to a learning curve. RESULTS: Band slippage occurred in 27 patients of the first group during the first period of 34 months (5.2%), and 5 more afterwards (total 6.2%). Only 3 patients of the second group (0.6%) had a slippage during the same period of time. CONCLUSION: Although the problem of band slippage is not likely to be completely solved, changing the technique has made it possible to decrease the rate of this complication. The height or the shape of different types of band also remain under scrutiny.