clinicaltrials.gov Identifier: NCT00793143.

IMPORTANCE Laparoscopic sleeve gastrectomy (LSG) is currently the predominant bariatric procedure, although long-term weight loss and quality-of-life (QoL) outcomes compared with laparoscopic Roux-en-Y gastric bypass (LRYGB) are lacking.OBJECTIVE To determine weight loss equivalence of LSG and LRYGB at 7 years in patients with morbid obesity, with special reference to long-term QoL. DESIGN, SETTING, AND PARTICIPANTS The SLEEVE vs byPASS (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted between March 10, 2008, and June 2, 2010, in Finland. The trial enrolled 240 patients with morbid obesity aged 18 to 60 years who were randomized to undergo either LSG or LRYGB with a 7-year follow-up (last follow-up, September 26, 2017). Analysis was conducted on an intention-to-treat basis. Statistical analysis was performed from June 4, 2018, to November 8, 2019.INTERVENTIONS Laparoscopic sleeve gastrectomy (n = 121) or LRYGB (n = 119). MAIN OUTCOMES AND MEASURESThe primary end point was percentage excess weight loss (%EWL) at 5 years. Secondary predefined follow-up time points were 7, 10, 15, and 20 years, with included 7-year secondary end points of QoL and morbidity. Disease-specific QoL (DSQoL; Moorehead-Ardelt Quality of Life questionnaire [range of scores, -3 to 3 points, where a higher score indicates better QoL]) and general health-related QoL (HRQoL; 15D questionnaire [0-1 scale for all 15 dimensions, with 1 indicating full health and 0 indicating death]) were measured preoperatively and at 1, 3, 5, and 7 years postoperatively concurrently with weight loss. RESULTSOf 240 patients (167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline body mass index, 45.9 [6.0]), 182 (75.8%) completed the 7-year follow-up. The mean %EWL was 47% (95% CI, 43%-50%) after LSG and 55% (95% CI, 52%-59%) after LRYGB (difference, 8.7 percentage units [95% CI, 3.5-13.9 percentage units]). The mean (SD) DSQoL total score at 7 years was 0.50 (1.14) after LSG and 0.49 (1.06) after LRYGB (P = .63), and the median HRQoL total score was 0.88 (interquartile range [IQR], 0.78-0.95) after LSG and 0.87 (IQR, 0.78-0.95) after LRYGB (P = .37). Greater weight loss was associated with better DSQoL (r = 0.26; P < .001). At 7 years, mean (SD) DSQoL scores improved significantly compared with baseline (LSG, 0.50 [1.14] vs 0.10 [0.94]; and LRYGB, 0.49 [1.06] vs 0.12 [1.12]; P < .001), unlike median HRQoL scores (LSG, 0.88 [IQR, 0.78-0.95] vs 0.87 [IQR, 0.78-0.90]; and LRYGB, 0.87 [IQR, 0.78-0.92] vs 0.85 [IQR, 0.77-0.91]; P = .07). The overall morbidity rate was 24.0% (29 of 121) for LSG and 28.6% (34 of 119) for LRYGB (P = .42).CONCLUSIONS AND RELEVANCE This study found that LSG and LRYGB were not equivalent in %EWL at 7 years. Laparoscopic Roux-en-Y gastric bypass resulted in greater weight loss than LSG, but the difference was not clinically relevant based on the prespecified equivalence margins. There was no difference in long-term QoL between the procedures. Bariatric surgery was associat...

IMPORTANCE Long-term results from randomized clinical trials comparing laparoscopic sleeve gastrectomy (LSG) with laparoscopic Roux-en-Y-gastric bypass (LRYGB) are limited. OBJECTIVE To compare long-term outcomes of weight loss and remission of obesity-related comorbidities and the prevalence of gastroesophageal reflux symptoms (GERD), endoscopic esophagitis, and Barrett esophagus (BE) after LSG and LRYGB at 10 years. DESIGN, SETTING, AND PARTICIPANTS This 10-year observational follow-up evaluated patients in the Sleeve vs Bypass (SLEEVEPASS) multicenter equivalence randomized clinical trial comparing LSG and LRYGB in the treatment of severe obesity in which 240 patients aged 18 to 60 years with median body mass index of 44.6 were randomized to LSG (n = 121) or LRYGB (n = 119).

Background and Aims: the long-term efficacy of laparoscopic roux-en-y gastric bypass in the treatment of morbid obesity has already been demonstrated. laparoscopic sleeve gastrectomy has shown promising short-term results, but the long-term efficacy is still unclear. the aim of this prospective randomized multicenter study is to compare the results of roux-en-y gastric bypass and sleeve gastrectomy.Material and Methods: a total of 240 morbidly obese patients were randomized to undergo either roux-en-y gastric bypass or sleeve gastrectomy. the primary end point of study was weight loss, and the secondary end points were resolution of comorbidities and morbidity. the short-term results at 6 months were analyzed.Results: the mean excess weight loss at 6 months was 49.2% in the sleeve gastrectomy group and 52.9% in the roux-en-y gastric bypass group (p = 0.086). type 2 diabetes was resolved or improved in 84.3% of patients in the sleeve gastrectomy group and 93.3% in the roux-en-y gastric bypass group (p = 0.585). the corresponding results for arterial hypertension were 76.8% and 81.9% (p = 0.707) and for hypercholesterolemia 64.1% and 69.0% (p = 0.485). there was no mortality at 6 months. there was one major complication following sleeve gastrectomy and two after roux-en-y gastric bypass (p = 0.531). eight sleeve gastrectomy patients and 11 roux-en-y gastric bypass patients had minor complications (p = 0.403).