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Background The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. Methods Participants with body mass index (BMI) 40 to 45 kg/m 2 , or 35 to 40 kg/m 2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. Results At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months ( n  = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (−16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), HbA1c (−0.3 %), and systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. Conclusions vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. Trial Registration https://clinicaltrials.gov/ct2/show/NCT01327976

Background The objective of this study was to assess whether the use of staple line reinforcement (SLR) reduces staple line complications (SLC). Mechanical staple lines are essential for gastrointestinal surgery such as bariatric surgery. However, SLC, such as bleeding and leakage, still occur. The purposes of this study were to provide quantitative evidence on the relative efficacy of gastric SLR and to compare the rates of effectiveness of three commonly used methods. Methods A search of the medical literature in English language journals identified studies from Jan 1, 2000, to Dec 31, 2013, using the following reinforcement types: (1) no reinforcement, (2) oversewing, (3) a biocompatible glycolide copolymer, and (4) bovine pericardium after gastric bypasses and sleeve gastrectomies. Types of reinforcement were compared using a random-effects model. Results This meta-analysis reviewed 16,967 articles, extracting data on 56,309 patients concerning leak and 41,864 patients concerning bleeding. Over 40 % of patients had no reinforcement, resulting in the highest leak rate (2.75 %) and bleed rate (3.45 %). Overall, reinforcing with bovine pericardium had the lowest leak (1.28 %) and bleed (1.23 %) rates. Suture oversewing was better than no reinforcement but not as effective as bovine pericardium for leak (2.45 %) and bleed (2.69 %) rates. Buttressing with a biocompatible glycolide copolymer resulted in the second highest leak rate (2.61 %) and a bleed rate of 2.48 % but had significantly lower bleed rates than no reinforcement. Conclusions SLR provided superior results for patients compared to no reinforcement for reducing SLC. Buttressing with bovine pericardium resulted in the most favorable outcomes. The effectiveness of different methods used to reinforce the staple line in gastric surgery does not appear to be equal.

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

IntroductionPrevious 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 analysisThis 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 disseminationThe 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 numberNCT05015283.

Background/Objectives. Vagal block therapy (vBloc) is effective for moderate to severe obesity at one year. Subjects/Methods. The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL) and total weight loss (%TWL) in intent-to-treat analyses. At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study. Results. 18-month weight loss was 23% EWL (8.8% TWL) for vBloc and 10% EWL (3.8% TWL) for Sham (P<0.0001). vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL). Sham regained over 40% of the 17% EWL (6.4% TWL) by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved. Conclusions. Weight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.