Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial

Abstract

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). The initial trial was conducted from April 2008 to June 2010 in Finland, with last follow-up on January 27, 2021.

Interventions: LSG or LRYGB.

Main outcomes and measures: The primary end point was 5-year percentage excess weight loss (%EWL). This current analysis focused on 10-year outcomes with special reference to reflux and BE.

Results: At 10 years, of 240 randomized patients (121 randomized to LSG and 119 to LRYGB; 167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline BMI, 45.9 [6.0]), 2 never underwent surgery and there were 10 unrelated deaths; 193 of the remaining 228 patients (85%) completed follow-up on weight loss and comorbidities, and 176 of 228 (77%) underwent gastroscopy. Median (range) %EWL was 43.5% (2.1%-109.2%) after LSG and 50.7% (1.7%-111.7%) after LRYGB. Mean estimate %EWL was not equivalent between the procedures; %EWL was 8.4 (95% CI, 3.1-13.6) higher in LRYGB. After LSG and LRYGB, there was no statistically significant difference in type 2 diabetes remission (26% and 33%, respectively; P = .63), dyslipidemia (19% and 35%, respectively; P = .23), or obstructive sleep apnea (16% and 31%, respectively; P = .30). Hypertension remission was superior after LRYGB (8% vs 24%; P = .04). Esophagitis was more prevalent after LSG (31% vs 7%; P < .001) with no statistically significant difference in BE (4% vs 4%; P = .29). The overall reoperation rate was 15.7% for LSG and 18.5% for LRYGB (P = .57).

Conclusions and relevance: At 10 years, %EWL was greater after LRYGB and the procedures were not equivalent for weight loss, but both LSG and LRYGB resulted in good and sustainable weight loss. Esophagitis was more prevalent after LSG, but the cumulative incidence of BE was markedly lower than in previous trials and similar after both procedures.

Trial registration: ClinicalTrials.gov Identifier: NCT00793143.

Figure 1.. Flow Diagram for the Sleeve vs Bypass (SLEEVEPASS) Trial

GERD indicates gastroesophageal reflux disease; LSG, laparoscopic sleeve gastrectomy; LRYGB, laparoscopic Roux-en-Y gastric bypass; SADI-S, single anastomosis duodenoileal bypass with sleeve gastrectomy. ^aThe number of patients assessed for eligibility was not adequately recorded. ^bAnalyzed according to intention-to-treat. ^cThe specific causes of death were: 1 traffic incident, 1 drowning, 1 ketoacidosis, 1 pulmonary embolism, 1 uterine cancer, 1 cholangiocarcinoma, 1 lung cancer, 1 pancreatic cancer, and 2 alcohol overdose.

Figure 2.. Percentage Excess Weight Loss (%EWL) and Percentage Total Weight Loss (%TWL) for All Patients and Individual Patients After Laparoscopic Sleeve Gastrectomy (LSG) and Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) From Baseline to 10 years