Metabolic and Bariatric Surgery in Patients with Obesity Class V (BMI > 60 kg/m2): a Modified Delphi Study.

BACKGROUND: Metabolic and bariatric surgery (MBS) is the preferred method to achieve significant weight loss in patients with Obesity Class V (BMI > 60 kg/m2). However, there is no consensus regarding the best procedure(s) for this population. Additionally, these patients will likely have a higher risk of complications and mortality. The aim of this study was to achieve a consensus among a global panel of expert bariatric surgeons using a modified Delphi methodology. METHODS: A total of 36 recognized opinion-makers and highly experienced metabolic and bariatric surgeons participated in the present Delphi consensus. 81 statements on preoperative management, selection of the procedure, perioperative management, weight loss parameters, follow-up, and metabolic outcomes were voted on in two rounds. A consensus was considered reached when an agreement of ≥ 70% of experts' votes was achieved. RESULTS: A total of 54 out of 81 statements reached consensus. Remarkably, more than 90% of the experts agreed that patients should be notified of the greater risk of complications, the possibility of modifications to the surgical procedure, and the early start of chemical thromboprophylaxis. Regarding the choice of the procedure, SADI-S, RYGB, and OAGB were the top 3 preferred operations. However, no consensus was reached on the limb length in these operations. CONCLUSION: This study represents the first attempt to reach consensus on the choice of procedures as well as perioperative management in patients with obesity class V. Although overall consensus was reached in different areas, more research is needed to better serve this high-risk population.

Early Bowel Obstruction after Bariatric Surgery: An Analysis of the 2020-2021 MBSAQIP Database.

BACKGROUND: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program evaluates 30-day outcomes of bariatric cases performed in the United States. The Participant Use File in 2020 introduced bowel obstruction (BO). We compared the rates of BO, risk factors, and postoperative outcomes after laparoscopic Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and duodenal switch (DS). METHODS: Retrospective analysis of patients who underwent laparoscopic RYGB, SG, or DS obtained from the 2020-2021 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Patients who underwent either as a primary procedure with a body mass index >35 kg/m 2 were selected. Baseline characteristics, operative details, and postoperative complications were collected. The outcome of interest was BO occurring within 30 days. RESULTS: A total of 205,533 cases of which 148,944 were SG (72.4%), 54,606 were RYGB (26.5%), and 1983 were DS (1%). BO occurred in 0.74%, 0.4%, and 0.03% of patients who underwent an RYGB, DS, or SG, respectively. Patients with a BO in the RYGB group were more likely to be on immunosuppressive therapy (5.4% vs. 1.9%, P <0.001) with longer operative time (136.2 min±58.0 min vs. 117.4 min±53.6 min, P <0.001). SG patients with a BO were older (47.5±13.6 vs. 41.9±11.6, P =0.011) with longer operating times (98.6±63.8 vs. 68.9±33.4, P =0.002). Patients in the RYGB group with a BO had the highest rates of readmissions (71.9%) and reoperations (58.4%). CONCLUSIONS: Early bowel obstruction is rare after bariatric surgery. It is more common after RYGB and least common after SG. Readmission and reoperation rates were highest in patients with BO in the RYGB group.

Classification of Slippage Following Laparoscopic BariClip Gastroplasty.

INTRODUCTION: Laparoscopic BariClip gastroplasty (LBCG) is a new reversible gastric sleeve-like procedure without gastrectomy proposed to minimize the risk of severe complications. Still one of the possible complications described with LBCG is slippage. The purpose of the current manuscript is to analyze different cases of slippage and propose a classification of this complication. METHODS: A number of 381 patients who underwent LBCG in 8 different centers were analyzed concerning the risk of slippage. All cases with documented slippage were carefully reviewed in terms of patients' symptomatology (presence of satiety, vomiting), history of weight loss, radiological data, and management of their slippage. A new classification was proposed depending on the anatomy, the symptomatology, and the time of occurrence. RESULTS: We have identified a total of 17 cases (4.46%) of slippage following LBCG. In 11 patients, the slippage was symptomatic with repetitive vomiting and nausea, and in the remaining 6 patients, the slippage was identified by radiological studies for insufficient weight loss, weight regain, or routine radiological follow-up. Depending on the interval time, the slippage was classified as either immediate (in first 7 days) in 6 cases, early (in less than 90 days) in 4 cases, and late (after 3 months) in 7 cases. Evaluation of the radiological studies in these cases identified the following: anterosuperior displacement (type A) in 9 cases, posteroinferior displacement (type B) in 6 cases (one case after 3 months), and lateral displacement (type C) in the remaining 2 cases. The management of the slippage consisted of BariClip removal in 7 cases, repositioning in 5 cases, and conservative treatment in the remaining 5 cases. All patients with conservative treatment were recorded at the beginning of the experience. CONCLUSIONS: Slippage is a possible complication after LBCG. This classification of the different types of slippage can benefit the surgeon in the management and treatment of this complication of LBCG.

Evolving Technique of Laparoscopic Vertical Gastric Clip Placement.

INTRODUCTION: Laparoscopic BariClip gastroplasty (LBCG) will address a similar tubular restriction than the one achieved with the laparoscopic sleeve gastrectomy (LSG) at the level of the gastric fundus, while maintaining the advantage of simplicity and anatomic preservation. The purpose of the current study was to analyze the risk of slippage and to present the evolving technique by adding gastro-gastric plication of the gastric wall covering the BariClip at those areas where the gastric wall "slips" between the limbs of the clip. METHODS: All patients undergoing LBCG with the evolving technique of gastric plication around the device associated with antral gastroplasty from January 2021 to May 2022 were included in the study group (group A). A control group (group B) was designed with patients who underwent previous LBCG technique between May 2017 and June 2019. This is a case-controlled group with patients matched by gender and BMI. We have analyzed the postoperative complications and more notably the slippage. RESULTS: One hundred seventy-six patients (44 male and 132 female) with a mean age of 33 years (± 11) underwent evolving technique of LBCG. A control group of 67 patients who underwent previous technique of LBCG was included. All procedures were completed by laparoscopy with no intraoperative complication. For the study group, we have recorded a number of 5 slippages (2.8%). The diagnosis occurred during the first 6 months after the operation. The management consisted of repositioning-3 cases-and BariClip removal-2 cases. For the control group, we have recorded a number of 3 slippages (4.3%). All three patients underwent BariClip removal, with no repositioning. CONCLUSIONS: We reported a new technique of placement of the BariClip with additional gastric plication anterior, posterior, and volume reduction in the antrum to potentially reduce the rate of slippage and improve weight loss outcomes.

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.

Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone. METHODS: We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks. FINDINGS: Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery. INTERPRETATION: ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975. FUNDING: Apollo Endosurgery, Mayo Clinic.

COVID-19: IFSO LAC Recommendations for the Resumption of Elective Bariatric Surgery.

BACKGROUND: COVID-19 pandemic varies greatly and has different dynamics in every country, city, and hospital in Latin America. Obesity increases the risk of SARS-CoV-2 infection, and it is one of the independent risk factors for the most severe cases of COVID-19. Currently, the most effective treatment against obesity available is bariatric and metabolic surgery (BMS), which further resolves or improves other independent risk factors like diabetes and hypertension. OBJECTIVE: Provide recommendations for the resumption of elective BMS during COVID-19 pandemic. METHOD: This document was created by the IFSO-LAC Executive Board and a task force. Based on data collected from a survey distributed to all IFSO-LAC members that obtained 540 responses, current evidence available, and consensus reached by other scientific societies. RESULTS: The resumption of elective BMS must be a priority maybe similar to oncological surgery, when hospitals reach phase I or II, treating obesity patients in a NON-COVID area, avoiding inadvertent intrahospital contagion from healthcare provider, patients, and relatives. Same BMS indication and types of procedures as before the pandemic. Discard the presence of SARS-CoV-2 within 72 h prior to surgery. Continues laparoscopic approach. The entire team use N95 mask. Minimum hospital stays. Implement remote visits for the follow-up. CONCLUSION: Resumption of elective BMS is crucial because it is not only a weight loss operation but also resolves or improves comorbidities and appears to be an immune restorative procedure of obese patients in the medium term, offering them the same probability of contracting COVID-19 as the regular population.

Correction to: Endoscopic Argon Plasma Coagulation Vs. Multidisciplinary Evaluation in the Management of Weight Regain after Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.

In the original article the captions for Figs. 1-3 are incorrect.

Isolated sleeve gastrectomy stricture: a systematic review on reporting, workup, and treatment.

The isolated stricture after the sleeve gastrectomy is one of the possible surgical complications. Previous algorithms have been proposed to address the workup and treatment of sleeve gastrectomy stricture. However, current literature lacks standardization and systematic reviews on this topic. This study aimed to review all currently available publications and to create evidence-based recommendations. We searched Medline (PubMed), EMBASE, and Central Cochrane from inception to June 10, 2019. Inclusion criteria were studies reporting treatment of sleeve gastrectomy stricture with no associated leaks. The primary outcome was the reported clinical resolution rate. The final analysis included 32 articles. The pooled reported clinical resolution rate for the primary treatment was 68% (11/16), 82% (296/361), and 75% (34/45) for noninvasive medical therapy, endoscopic, and surgical treatments, respectively (not significant). Among the endoscopic modalities, the pneumatic dilation has the highest clinical success rate. Most rescue surgeries described in the literature were successful. Conclusively, the initial treatment should entail noninvasive medical management followed by the endoscopic approach, if needed. Pneumatic balloon dilation should be the preferred approach, if technically feasible. Revisional surgery should be reserved for endoscopic failure.

Laparoscopic Common Bile Duct Exploration With Primary Closure After Failed Endoscopic Retrograde Cholangiopancreatography Without Intraoperative Cholangiography: A Case Series from a Referral Center in Bogota, Colombia.

Background: Despite the effectiveness of laparoscopic common bile duct (CBD) surgery, no case series details the use and advantages of laparoscopic CBD exploration (LCBDE) without use of intraoperative cholangiography (IOC) in endoscopic retrograde cholangiopancreatography (ERCP) failure. Therefore, we present a case series regarding our success with LCBDE in managing CBD stones (CBDSs) using laparoscopic technique without IOC. Materials and Methods: We performed a descriptive retrospective observational study. Patients with CBDSs, alone or along with gallbladder stones, were treated through LCBDE with primary CBD closure after failed ERCP. Results: All patients underwent LCBDE with choledocotomy and primary duct closure. Patients with gallbladder stones underwent laparoscopic cholecystectomy (78%). All procedures were successful, and no conversions occurred. Surgery duration averaged 106 minutes. Intraoperative bleeding averaged 15 cc, and no mortalities occurred. No patients required additional surgery or intensive care unit admission. Hospitalization duration averaged 5 days. Conclusions: Therefore, a laparoscopic approach with primary CBD closure after failed ERCP for complex CBDSs is safe and effective.

Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.

BACKGROUND: Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC). OBJECTIVE: Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC. METHODS: A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain. RESULTS: Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control). CONCLUSION: Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.

Laparoscopic vertical clip gastroplasty - quality of life.

BACKGROUND: Over the last decade, several techniques have emerged and the bariatric trends have changed. A new bariatric procedure that has been proposed is laparoscopic vertical clip gastroplasty (LVCG), which mimics the principle of laparoscopic sleeve gastrectomy, but with a completely reversible mechanism. The introduction of a new procedure in the bariatric armamentarium necessitated a period of preclinical and clinical studies and a validation of the procedure concerning the quality of life. SETTING: Private hospital, Dominican Republic. OBJECTIVES: The purpose of this manuscript was to evaluate patient satisfaction, measured by various questionnaires after LVCG. METHODS: From November 2012 to February 2017, 138 patients underwent LVCG and demographic data were collected prospectively. A total of 82 were evaluated for quality of life with a minimum follow-up of 6 months after the procedure. The quality of life was also analyzed regarding the complications and resolution of different medical conditions included in the Bariatric Analysis and Reporting Outcome System score. RESULTS: Eighty-five patients (73.9%) agreed to participate in the study and a total of 82 patients completed the questionnaires at all points in time. Seventy-one patients were female, with an average age of 34 (19-38). Mean body mass index before operation was 42.4 kg/m2 and declined significantly in both the first and second year postoperatively to 33.7 kg/m2 (1-year follow-up) in 65 patients and 34.3 kg/m2 (2-year follow-up) in 37 patients. The results showed failure for 1.2% of patients and were fair for 6.1% of cases. Quality of life was assessed as good for 26 patients (31.8%), as very good for 39 patients (47.5%), and as excellent for 11 patients (13.4%). CONCLUSIONS: LVCG represents a new bariatric procedure that mimics the principle of laparoscopic sleeve gastrectomy, but with a completely reversible mechanism. The procedure consists of a nonadjustable clip that is vertically placed parallel to the lesser curvature. After >3 years of clinical use, the weight loss results seem to be encouraging and up to 92.7% of patients have an improved quality of life.

Efficacy of Utilizing Argon Plasma Coagulation for Weight Regain in Roux-en-Y Gastric Bypass Patients: a Multi-center Study.

BACKGROUND: Endoscopic approaches exist for targeting weight regain after Roux-en-Y gastric bypass (RYGB), including endoscopic suturing, clipping, and sclerotherapy. Argon plasma coagulation (APC) is a noncontact electrocoagulation method, and when used in RYGB patients, it has shown reduction in the diameter of the gastrojejunal anastomosis. OBJECTIVES: To study the effectiveness of APC for weight regain in terms of weight loss for RYGB patients, from eight bariatric centers. METHODS: A retrospective chart review was performed for 558 patients at eight bariatric centers in the USA (1) and Brazil (7) who underwent APC procedure between 31st July 2009 and 29th March 2017. APC was performed on patients who regained weight after RYGB procedure. RESULTS: Upon exploratory analysis of the individual BMI data, the mean BMI decreased slightly during the first 24 months and increased slightly afterwards following the APC intervention. The mean weight was 94.5 ± 18.6 kg and the mean BMI was 34.0 kg/m2 at APC. Where data were available, the mean of lowest weight was 67.0 ± 23.0 kg and the mean of lowest BMI was 24.1 kg/m2 following gastric bypass. The mean weight loss was 6.5, 7.7, and 8.3 kg at 6, 12, and 24 months, respectively, and the changes in weight over time was statistically significant (p < 0.0001). Multi-level for change model showed the low body mass index (BMI) group (BMI < 30 kg/m2) to have greater TWL than the high BMI (BMI ≥ 30 kg/m2) group at 6, 12, and 24 months. In the low BMI group, the mean TWL was 4.7, 6.1, 6.9, and 2.4%, at 6, 12, and 24 months, respectively. In the high BMI group, the mean TWL was 7.5, 10.4, 13.4, and 3.7%, at 6, 12, 24, and 36 months, respectively. Of the 333 patients in four centers who provided complication information, complications after APC included stenosis (n = 9), GJ ulcer (n = 3), vomiting (n = 3), GJ leakage (n = 2), and melena (n = 1). CONCLUSION: APC can be useful in reducing the regained weight after RYGB, and patients showed 6-10% total weight loss at 12 months. Randomized trials would be needed to validate the findings.

A Single-center Experience Examining the Length of Stay and Safety of Early Discharge After Laparoscopic Roux-en-Y Gastric Bypass Surgery.

PURPOSE: This study's objective was to describe our experience and evaluate the safety of early discharge (ED) following laparoscopic Roux-en-Y gastric bypass (LRYGB) in a specific patient population. MATERIALS AND METHODS: Patients undergoing LRYGB at Montefiore Medical Center were retrospectively reviewed. Patients readmitted in the first 30 days following surgery were compared to those patients who were not readmitted. Data analysis was used to compare groups and to determine factors associated with readmission. In addition to patient demographics, length of stay (LOS) was analyzed as an independent risk factor for readmission. RESULTS: A total of 630 LRYGB were performed during this period. There were 5.1% (n = 32) of patients that required readmission within 30 days of discharge. Readmitted patients had a higher BMI (50.0 vs. 45.8; p = 0.006) and there was a trend for them to be younger (38.4 years vs. 42.0; p = 0.07). There was an increased rate of ED in 2015 (36.7%, n = 121) compared to 2014 (29.9%, n = 90). The readmission rate for ED for the study period was 4.7% (n = 10). There were no observed mortalities in our early discharge group of patients. CONCLUSIONS: Discharge on post-operative day 1 following a LRYGB is safe and is not associated with an increased likelihood of being readmitted within 30 days of discharge. Our single-center experience helps to better characterize current patient profiles and length of stay trends within the field and can be used to establish a randomized controlled trial for discharging patients early after LRYGB.

Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique.

BACKGROUND: Endoscopic sutured gastroplasty (ESG) has evolved over time. With the advent of full-thickness endoscopic suturing, an efficient technique for ESG was developed and refined. METHODS: This prospective first-in-man trial started in April 2012 and represents the first use of full-thickness endoscopic suturing for primary obesity therapy. The trial focused on procedure development, reproducibility, safety, and short-term efficacy. The trial was performed at centers in five countries, in three phases. Phase I was evaluation of safety and technical feasibility of various procedure techniques; stitch patterns and sequences were assessed for efficiency, safety, and feasibility. Phase II entailed continued procedure refinement to establish a standardized technique. Phase III entailed evaluation of technical feasibility and weight loss outcomes in 77 patients; the procedure was performed using the standardized technique, and there was no procedure development. Data were prospectively collected into a registry. RESULTS: In Phase I, the procedure was created and modified to improve time efficiency. Safety and technical feasibility were established, and short-term weight loss was demonstrated. In Phase II, a number of stitch patterns were attempted, and the stitch pattern was modified and finalized. 22 patients were included, and 1-year total weight loss was 17.3 ± 2.6%. In Phase III, conformity with the final technique was high. 77 patients were included, with a mean BMI of 36.1 ± 0.6 kg/m2. Mean weight loss was 16.0 ± 0.8% at 6 months and 17.4 ± 1.2% at 12 months (n = 44). Postprocedural nausea, vomiting, and epigastric pain were frequently reported; there were no reported significant adverse events post-procedure or during the follow-up period. CONCLUSIONS: Following a methodical procedure development phase, ESG demonstrated safety and short-term efficacy in this trial. The procedure also achieved meaningful weight loss during the follow-up period.

Transoral outlet reduction with full thickness endoscopic suturing for weight regain after gastric bypass: a large multicenter international experience and meta-analysis.

BACKGROUND AND AIMS: Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature. METHODS: Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used. RESULTS: 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18 months after TORe was 9.31 ± 6.7 kg (N = 84), 7.75 ± 8.4  kg (N = 70), 8 ± 8.8 kg (N = 46) (p < 0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12 months was 8.4 kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p = 0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported. CONCLUSION: When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.

Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Second IFSO Global Registry Report 2013-2015.

BACKGROUND: Five International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) surveys since 1998 have estimated the volume and type of bariatric surgery being done in constituent member countries. These reports did not include baseline demographic descriptions. METHODS: An IFSO Global Registry pilot project in 2014 demonstrated that it was possible to amalgamate large numbers of individual patient data from different local and national database systems. Here we describe demographic data from the second report for 54,490 patients from 31 countries operated in the 3 calendar years 2013-2015 and follow up data from 66,560 of 112,544 patients in 2009-2015. RESULTS: Most procedures (97.8%) were performed laparoscopically and 73.3% (95% CI: 73.0-73.7%, range 54.2 to 80.3%) were female. The average age was 42.0 years (95% CI 41.9-42.1, inter-quartile range 33.0-51.0 years) and the median body mass index was 43.3 kg/m2 (inter-quartile range 39.4-48.8 kg/m2). Before surgery, 22.0% patients had type 2 diabetes (inter-country variation 7.4-63.2%); 31.9% were hypertensive (15.8-92.7%); 17.6% had depression (0.0-46.3%); 27.8% took medication for musculoskeletal pain (0.0-58.9%); 18.9% had sleep apnea (0.0-63.2%); and 29.6% of patients had gastro-esophageal reflux disease (9.1-90.9%). Gastric bypass was the most prevalent operation (49.4%), followed by sleeve gastrectomy (40.7%) and gastric banding (5.5%). The 1-year total weight loss for patients with available data was 30.53% (95% CI: 30.22-30.84%) and in the cohort 2009-15 was 30.4% with a follow-up rate of 59.14%. In the 2009-2015 cohort, 64.7% of patients on treatment for diabetes preoperatively were not on treatment postoperatively. CONCLUSIONS: There is widespread variation in access to surgery and in baseline patient characteristics in the countries submitting data to the IFSO Global Registry.