Semaglutide vs Endoscopic Sleeve Gastroplasty for Weight Loss.

Importance: Obesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making. Objective: To assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity. Design, Setting, and Participants: This economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life. Interventions: Strategies included treatment with semaglutide and ESG. Main Outcomes and Measures: Costs (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed. Results: The model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591. Conclusions and Relevance: This study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.

Septic Shock After Endoscopic Sleeve Gastroplasty: A Post-procedural Complication?

BACKGROUND: ESG is a safe and effective technique in the obesity management, usually indicated in class I and II obesity. It is also an acceptable treatment in patients with class III obesity who have high surgical risk or refuse surgery. This procedure results in a significant weight loss and important improvement in metabolic comorbidities. Nevertheless, there are several procedure-related complications. Few cases of gastric perforation following ESG have been reported. We present a case of septic shock after ESG with preoperative diagnostic uncertainties. METHODS: We present the case of a 54-year-old male with a BMI of 43.6 kg/m2 who underwent ESG 7 days before in an external center. The patient came to the emergency department presenting abdominal pain, nausea, and vomiting since the day after the procedure. Physical examination revealed hemodynamic instability, altered level of consciousness, diffuse abdominal pain, and a painful umbilical lump due to a complicated umbilical hernia. Emergent surgery was decided after preoperative assessment. RESULTS: Intraoperative gastroscopy was performed, viewing a gastric ischemic ulcer covered with fibrin and a mucosal defect and suspecting a covered gastric perforation. Firstly, we performed an open approach to the complicated umbilical hernia. Subsequently, an exploratory laparoscopy was performed through the hernial ring, where a fibrin-covered area was evidenced in the anterior face of the gastric body, adhered to the round ligament by a transmural suture of the ESG. Additionally, multiple transmural sutures were observed adhered to the greater omentum and lesser sac and an intramural hematoma in the greater gastric curvature. No intra-abdominal free fluid was evidenced. A laparoscopic barbed suture of the area covered with fibrin was performed, after its release from the round ligament. The adhesions of the sutures and metallic material from the ESG were released. Finally, two abdominal drains were placed in the anterior and posterior gastric face. The patient presented superficial incisional surgical site infection and was discharged 6 days after laparoscopic surgery. CONCLUSIONS: ESG is a novel procedure, which has proven to be an effective alternative in the treatment of obesity. However, this technique may have major complications that can require urgent surgery.

Medium and Long-Term Weight Loss After Revisional Bariatric Surgery: A Systematic Review and Meta-Analysis.

Despite the current increase in revisional bariatric surgery (RBS), data on the sustainability of weight loss remain unclear. A systematic review and meta-analysis were performed to assess weight loss outcomes in adult patients undergoing RBS with follow-up > 2 years. Twenty-eight observational studies (n = 2213 patients) were included. The %TWL was 27.2 (95%CI = 23.7 to 30.6), and there was a drop in BMI of 10.2 kg/m2 (95%CI = - 11.6 to - 8.7). The %EWL was 54.8 (95%CI = 47.2 to 62.4) but with a high risk of publication bias (Egger's test = 0.003). The overall quality of evidence was very low. Our data reinforce that current evidence on RBS is mainly based on low-quality observational studies, and further higher-quality studies are needed to support evidence-based practice.

From adjustable gastric banding to Roux-en-Y gastric bypass - case report.

INTRODUCTION: Adjustable gastric banding (AGB) used to be a popular bariatric procedure. However, it fails in more than half of those operated on in the long term, becomes ineffective and must be removed. Therefore, the use of AGB has been in decline globally. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most used bariatric revision surgeries when AGB is removed. CASE REPORT: We present the case of a woman after AGB removal and conversion to SG who developed a stenosis of the sleeve. Therefore, a decision was made to convert to RYGB with a good effect. CONCLUSION: Revisional procedures are more technically challenging than primary procedures and have higher complication rates. The most performed revisional operations include SG and RYGB. Stenosis of the sleeve can occur after SG, with a negative impact on the patient's nutritional status and quality of life. This can be managed by endoscopic dilatation, and where this solution proves ineffective, RYGB can be indicated.

Success Predictors of Endoscopic Sleeve Gastroplasty.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive procedure that proved to be safe and effective in obesity treatment. However, not all subjects respond to treatment in the same way, and, with a view to personalized care, it is essential to identify predictors of success or failure. METHODS: A retrospective 2-year followed-up cohort of ESG subjects was analyzed to investigate the presence of any baseline or early indicators of long-term optimal or suboptimal ESG outcomes. RESULTS: A total of 315 subjects (73% women) were included, with 73% of patients exhibiting an Excess weight loss percentage (%EWL) >25% at the 24 months. Neither demographic parameters (age and sex), smoking habits, and menopause in women nor the presence of comorbidities proved potential predictive value. Interestingly, the %EWL at 1 month after ESG was the strongest predictor of 24-month therapeutic success. Subsequently, we estimated an "early threshold for success" for 1 month-%EWL by employing Youden's index method. CONCLUSIONS: ESG is a safe and effective bariatric treatment that can be offered to a wide range of subjects. Early weight loss seems to impact long-term ESG results significantly and may allow proper early post-operative care optimization.

A case of laparoscopic revision surgery 30 years after vertical banded gastroplasty for morbid obesity.

As the number of bariatric and metabolic surgeries being performed is increasing, the importance of revision surgeries is escalating. In this report, we describe a case of revision surgery performed 30 years after vertical banded gastroplasty (VBG), including a review of the surgical techniques. The patient was a male in his 50s who had previously undergone VBG for morbid obesity (body mass index of 72.6 kg/m2 ), resulting in gradual weight loss. Twenty-eight years later, reflux symptoms due to stenosis of the mesh area developed. Despite conservative treatment, the symptoms recurred, and aspiration pneumonia developed. Gastrojejunal and Y-anastomoses were performed laparoscopically. Postoperatively, the patient progressed well with no weight regain. In revision surgery, it is essential to accurately assess the patient's pathophysiology, as the surgical technique must consider improvement in symptoms, risk of weight regain, and the need for observation of the residual stomach.

Nissen Sleeve as a Redo Surgery Post Gastric Banding for Non-responders to Weight Loss and Therapy-Resistant Reflux.

Roux-en-Y gastric bypass (LRYGB) would be the procedure of choice for non-responders of weight loss and patients with reflux symptoms (GERD). However, not every patient is a candidate for RYGB, and sometimes, the patient can insist only on alternatives other than malabsorption procedures, as was the case with our patient. We report a case with symptomatic GERD who underwent a successful Nissen sleeve gastrectomy after band removal. To our knowledge, this is the first case using Nissen sleeve as a redo surgery after a previous bariatric procedure.

Outcomes of Endoscopic Sleeve Gastroplasty Following Laparoscopic Adjustable Gastric Band: A Propensity Score-matched Analysis.

BACKGROUND: The performance of endoscopic sleeve gastroplasty (ESG) in patients with prior laparoscopic adjustable gastric band (LAGB) has not been characterized. MATERIALS AND METHODS: This is a retrospective propensity score-matched study of ESG after LAGB at 2 centers with expertise in bariatric endoscopy. The primary outcome was total weight loss (TWL) at 12 months. Secondary outcomes included TWL at 3 and 6 months, 12-month excess weight loss (EWL), procedural characteristics, predictors of TWL, and serious adverse events. RESULTS: Twenty-six adults (88.5% female, age 50.8 y, BMI 36.5 kg/m 2 ) with prior LAGB (median duration 8 y) underwent ESG at a median of 3 years after LAGB removal. A 2:1 age-matched, sex-matched, and BMI-matched comparator group was created, comprising ESG patients from the same organization and time frame but without prior LAGB. TWL for the LAGB-to-ESG cohort versus the ESG-only cohort was 10.1±5.5% versus 13.0±4.4% at 3 months ( P =0.0256), 12.4±7.2% versus 16.0±5.4% at 6 months ( P =0.0375), and 12.7±8.2% versus 18.4±6.5% at 12 months ( P =0.0149). At 12 months, the LAGB-to-ESG cohort had an EWL of 52.5±50.0%, and 75% achieved TWL ≥10%. There was no association between TWL at 3, 6, or 12 months and the following traits: age or BMI at the time of ESG, patient sex, and time from LAGB removal to ESG. No serious adverse events occurred in either cohort. CONCLUSION: ESG after LAGB facilitates safe and clinically meaningful weight loss but is attenuated compared to primary ESG.

Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis.

PURPOSE: Magnetic Sphincter Augmentation (MSA) is an FDA-approved anti-reflux procedure with comparable outcomes to fundoplication. However, most data regarding its use are limited to single or small multicenter studies which may limit the generalizability of its efficacy. The purpose of this study is to evaluate the outcomes of patients undergoing MSA vs fundoplication in a national database. MATERIALS AND METHODS: The 2017-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Registry was utilized to evaluate patients undergoing MSA or fundoplication. Patients requiring Collis gastroplasty, paraesophageal hernia repair, and emergency cases, were excluded. Patient outcomes included overall complication rates, readmissions, reoperations, and mortality. RESULTS: A total of 7,882 patients underwent MSA (n = 597) or fundoplication (n = 7285). MSA patients were younger (51 vs 57, p < 0.001), and more often male (49.6 vs 34.3%, p < 0.001). While patients undergoing MSA experienced similar rates of reoperation (1.0 vs 2.0%, p = 0.095), they experienced fewer readmissions (2.2 vs 4.7%, p = 0.005), complications (0.6 vs 4.0%, p < 0.001), shorter mean (SD) hospital length of stay(days) (0.4 ± 4.3 vs 1.8 ± 4.6, p < 0.001) and operative time(min) (80.8 ± 36.1 vs 118.7 ± 63.7, p < 0.001). Mortality was similar between groups (0 vs 0.3%, p = 0.175). On multivariable analysis, MSA was independently associated with reduced postoperative complications (OR 0.23, CI 0.08 to 0.61, p = 0.002), readmissions (OR 0.53, CI 0.30 to 0.94, p = 0.02), operative time (RC - 36.56, CI - 41.62 to - 31.49. p < 0.001) and length of stay (RC - 1.22, CI - 1.61 to - 0.84 p < 0.001). CONCLUSION: In this national database study, compared to fundoplication MSA was associated with reduced postoperative complications, fewer readmissions, and shorter operative time and hospital length of stay. While randomized trials are lacking between MSA and fundoplication, both institutional and national database studies continue to support the use of MSA as a safe anti-reflux operation.

Endoscopic sleeve gastroplasty: stomach location and task classification for evaluation using artificial intelligence.

PURPOSE: We have previously developed grading metrics to objectively measure endoscopist performance in endoscopic sleeve gastroplasty (ESG). One of our primary goals is to automate the process of measuring performance. To achieve this goal, the repeated task being performed (grasping or suturing) and the location of the endoscopic suturing device in the stomach (Incisura, Anterior Wall, Greater Curvature, or Posterior Wall) need to be accurately recorded. METHODS: For this study, we populated our dataset using screenshots and video clips from experts carrying out the ESG procedure on ex vivo porcine specimens. Data augmentation was used to enlarge our dataset, and synthetic minority oversampling (SMOTE) to balance it. We performed stomach localization for parts of the stomach and task classification using deep learning for images and computer vision for videos. RESULTS: Classifying the stomach's location from the endoscope without SMOTE for images resulted in 89% and 84% testing and validation accuracy, respectively. For classifying the location of the stomach from the endoscope with SMOTE, the accuracies were 97% and 90% for images, while for videos, the accuracies were 99% and 98% for testing and validation, respectively. For task classification, the accuracies were 97% and 89% for images, while for videos, the accuracies were 100% for both testing and validation, respectively. CONCLUSION: We classified the four different stomach parts manipulated during the ESG procedure with 97% training accuracy and classified two repeated tasks with 99% training accuracy with images. We also classified the four parts of the stomach with a 99% training accuracy and two repeated tasks with a 100% training accuracy with video frames. This work will be essential in automating feedback mechanisms for learners in ESG.

Revisional One-Step Bariatric Surgical Techniques After Unsuccessful Laparoscopic Gastric Band: A Retrospective Cohort Study with 2-Year Follow-up.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has high reported rates of revision due to poor weight loss (WL) and high complication rates. Yet, there is yet to be a consensus on the best revisional procedure after unsuccessful LAGB, and studies comparing different revisional procedures after LAGB are still needed. METHODS: This was a retrospective cohort study that compared the outcomes of one-step revisional Roux-en-Y gastric bypass (rRYGB), one-anastomosis gastric bypass (rOAGB), or laparoscopic sleeve gastrectomy (rLSG) after LAGB. WL, complications, resolution of associated medical conditions, and food tolerance were assessed with a post hoc pairwise comparison one-way analysis of variance (ANOVA) throughout a 2-year follow-up. RESULTS: The final analysis included 102 (rRYGB), 80 (rOAGB), and 70 (rLSG) patients. After 2 years, an equal percentage of excess weight loss was observed in rOAGB and rRYGB (both >90%; p=0.998), significantly higher than that in rLSG (83.6%; p<0.001). In our study, no leaks were observed. rRYGB had higher complication rates according to the Clavien-Dindo classification (10.8% vs. 3.75% and 5.7% in rOAGB and rLSG, respectively, p=0.754), and re-operations were not statistically significant. Food tolerance was comparable between rOAGB and rRYGB (p = 0.987), and both had significantly better food tolerance than rLSG (p<0.001). The study cohorts had comparable resolution rates for associated medical problems (p>0.60). CONCLUSION: rOAGB and rRYGB had better outcomes after LAGB than rLSG regarding WL, feasibility, food tolerance, and safety. rOAGB had significantly higher rates of nutritional deficiencies.

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.

Laparoscopic Adjustable Gastric Band Colonization May Indicate Re-classification of Surgical Wounds.

BACKGROUND: Surgical wounds are classified as either clean, clean-contaminated, contaminated, or dirty wounds. Historically laparoscopic adjustable gastric band (LAGB) removals have been classified as clean wounds since there is thought to be no existing infection and no transection of the gastrointestinal tract. Surgical site infection (SSI) remains a publicly reported source of morbidity after laparoscopic bariatric surgery and is considered a CMS hospital-acquired condition. We present a retrospective chart review to reveal the rate of bacterial colonization of gastric bands. METHODS: This retrospective chart review included 15 patients who underwent removal of LAGB. The entire LAGB and port were removed and then sent for aerobic and anaerobic cultures. Patients were followed up to 1 month, and the incidence of surgical site infection development was recorded. RESULTS: Of the fifteen LAGBs cultured, eight cases (53%) returned positive for bacterial growth. Five of the cultures (33%) were positive for coagulase-negative Staphylococcus. One culture was positive for micrococcus species (6.7%), one culture was positive for Bacteroides fragilis (6.7%) and another was positive for Propionibacterium (6.7%). None of the 15 patients followed in the study developed an SSI by the end of 1 month. CONCLUSIONS: Given the consideration of LAGB removals as clean wounds, the incidence of LAGB colonization is high. Classification of the surgical wounds in LAGB removals should be changed from clean to contaminated. Further studies need to be pursued to determine the correlation between colonized LAGBs and the rate of SSIs. KEY POINTS: • Gastric band removals are a common bariatric procedure. • Surgical site infection remains an outcome of interest to patient, surgeon and payor. • Fifty-three percent of recovered bands were positive for bacterial growth.

Machine learning models to predict success of endoscopic sleeve gastroplasty using total and excess weight loss percent achievement: a multicentre study.

BACKGROUND: The large amount of heterogeneous data collected in surgical/endoscopic practice calls for data-driven approaches as machine learning (ML) models. The aim of this study was to develop ML models to predict endoscopic sleeve gastroplasty (ESG) efficacy at 12 months defined by total weight loss (TWL) % and excess weight loss (EWL) % achievement. Multicentre data were used to enhance generalizability: evaluate consistency among different center of ESG practice and assess reproducibility of the models and possible clinical application. Models were designed to be dynamic and integrate follow-up clinical data into more accurate predictions, possibly assisting management and decision-making. METHODS: ML models were developed using data of 404 ESG procedures performed at 12 centers across Europe. Collected data included clinical and demographic variables at the time of ESG and at follow-up. Multicentre/external and single center/internal and temporal validation were performed. Training and evaluation of the models were performed on Python's scikit-learn library. Performance of models was quantified as receiver operator curve (ROC-AUC), sensitivity, specificity, and calibration plots. RESULTS: Multicenter external validation: ML models using preoperative data show poor performance. Best performances were reached by linear regression (LR) and support vector machine models for TWL% and EWL%, respectively, (ROC-AUC: TWL% 0.87, EWL% 0.86) with the addition of 6-month follow-up data. Single-center internal validation: Preoperative data only ML models show suboptimal performance. Early, i.e., 3-month follow-up data addition lead to ROC-AUC of 0.79 (random forest classifiers model) and 0.81 (LR models) for TWL% and EWL% achievement prediction, respectively. Single-center temporal validation shows similar results. CONCLUSIONS: Although preoperative data only may not be sufficient for accurate postoperative predictions, the ability of ML models to adapt and evolve with the patients changes could assist in providing an effective and personalized postoperative care. ML models predictive capacity improvement with follow-up data is encouraging and may become a valuable support in patient management and decision-making.

Outcome comparison between primary and revisional bariatric surgery: A propensity-matched analysis.

BACKGROUND: Revisional bariatric procedures for weight recurrence are rising but are considered higher risk and less effective than primary bariatric procedures. This study aimed to compare clinical outcomes between primary and revisional bariatric surgery for weight recurrence. METHODS: Prospectively collected data from adult patients who underwent revisional or primary bariatric surgery from 2016 to 2020 in an academic institution were reviewed. Roux-en-Y gastric bypass and sleeve gastrectomy were performed primarily or as conversion procedures after laparoscopic adjustable gastric band, vertical banded gastroplasty, and sleeve gastrectomy. 1:1 propensity score matching was performed between revisional bariatric surgery and primary bariatric surgery, and logistic regression analysis was used to compare up to 2-year weight loss and comorbidity resolution outcomes. RESULTS: A total of172 cases (86 revisional bariatric surgery versus 86 primary bariatric surgery) were included. Groups were matched for age, sex, preoperative body mass index, bariatric procedure, diabetes, hypertension, and obstructive sleep apnea. Procedure duration (203 ± 78 vs 154 ± 69 minutes; P < .001) and length of stay (2.3 ± 2.1 vs 1.7 ± 1 days; P = .02) were longer for revisional bariatric surgery versus primary bariatric surgery, respectively. Total weight loss was less in revisional bariatric surgery compared with primary bariatric surgery at 1 year (23 ± 10% vs 32 ± 9%; P < .001) and 2 years (21 ± 12.% vs 32 ± 10%; P < .001) of follow-up; however, no differences were detected in postoperative occurrences, emergency department visits, readmissions, reintervention and reoperation rates, and comorbidity resolution. CONCLUSION: Although revisional bariatric surgery was associated with longer operation times, prolonged hospitalization, and lower weight loss than primary bariatric surgery, it was accomplished safely and led to substantial weight loss and comorbidity resolution. This information can guide patient counseling before revisional surgery for weight recurrence.

Performance of Endoscopic Sleeve Gastroplasty by Obesity Class in the United States Clinical Setting.

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) has gained popularity over the past decade and has been adopted in both academic and private institutions globally. We present outcomes of the largest cohort of patients from the United States undergoing ESG and evaluate these according to obesity class. METHODS: We performed a retrospective analysis of adult patients who underwent ESG. Medical information was abstracted from the electronic record with weight records up to 2 years after ESG. Percent total body weight loss (%TBWL) at 6, 12, 18, and 24 months was calculated based on baseline weight at the procedure. SPSS (version 29.0) was used for all statistical analyses. RESULTS: A total of 1,506 patients from 7 sites were included (501 Class I obesity, 546 Class II, and 459 Class III). Baseline demographics differed according to obesity class due to differences in age, body mass index (BMI), height, sex distribution, and race. As early as 6 months post-ESG, mean BMI for each class dropped to the next lower class and remained there through 2 years. %TWBL achieved in the Class III group was significantly greater when compared with other classes at all time points. At 12 months, 83.2% and 60.9% of patients had ≥10% and ≥15% TBWL for all classes. There were no differences in adverse events between classes. DISCUSSION: Real-world data from a large cohort of patients of all BMI classes across the United States shows significant and sustained weight loss with ESG. ESG is safe to perform in a higher obesity class with acceptable midterm efficacy.

Banded Versus Non-banded Sleeve Gastrectomy: 5-Year Results of a 3-Year Randomized Controlled Trial.

PURPOSE: Banded sleeve gastrectomy (BSG) has been shown to enable better weight loss than non-banded sleeve gastrectomy (SG) in retrospective analyses. These findings were supported by two randomized controlled trials (RCT). However, to date, mid-term prospective data is not available. MATERIALS AND METHODS: We invited all 94 patients of an RCT comparing banded to non-banded sleeve gastrectomy at 3 years (DRKS00007729) for a 5-year follow-up visit. Eighty-two patients (BSG n = 42; SG n = 40) came for evaluation. Outcome measures were identical with the RCT to allow longitudinal comparison. Data analysis was descriptive and focused on biometric data, development of comorbidities, mid-term complications, quality of life, and type of body contouring surgery (BCS). RESULTS: The per-protocol analysis revealed a treatment difference of 9% (CI - 1.5 to 19.6) excess weight loss (EWL). Total weight loss (TWL) was 27.4% (CI 23.5-31.3) after SG and 31.6% (CI 27.3-35.5) after BSG. Twenty percent of patients after SG and 11.9% following BSG had been converted to a gastric bypass. Type 2 diabetes went into remission in most patients (SG 66.7% vs. BSG 63.6%). Antihypertensive medication was stopped or reduced in 81.3% after SG and 80% after BSG. Reflux symptoms were similar in both groups (symptoms [Formula: see text] 1/ week: SG 28.2% vs. BSG 26.8%). Frequency of postprandial regurgitation was higher after BSG (SG 23% vs. BSG 59%). Forty percent of patients had undergone BCS at time of follow-up. CONCLUSION: Five-year weight loss after BSG was 9% EWL and 4.2% TWL higher compared to SG. The main added morbidity following BSG was postprandial regurgitation.