Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial

Abstract

Importance: Sleeve gastrectomy is increasingly used in the treatment of morbid obesity, but its long-term outcome vs the standard Roux-en-Y gastric bypass procedure is unknown.

Objective: To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events.

Design, setting, and participants: The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period.

Interventions: Patients were randomly assigned to undergo laparoscopic sleeve gastrectomy (n = 107) or laparoscopic Roux-en-Y gastric bypass (n = 110).

Main outcomes and measures: The primary end point was weight loss, expressed as percentage excess body mass index (BMI) loss. Exploratory end points were changes in comorbidities and adverse events.

Results: Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, -7.18%; 95% CI, -14.30% to -0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass.

Conclusions and relevance: Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery.

Trial registration: clinicaltrials.gov Identifier: NCT00356213.

Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE form for Disclosure of Potential Conflicts of Interest. Dr Peterli reports serving as a consultant for Johnson & Johnson. Dr Bueter reports receipt of compensation from Medtronics and Johnson & Johnson for invited lectures. No other disclosures were reported.

Figures

Figure 1.. Participant Flow Through the Swiss Multicenter Bypass or Sleeve Study

Figure 2.. Percentage Excess BMI Loss After Sleeve Gastrectomy (n=101) or Roux-en-Y Gastric Bypass (n=104) Over 5 Years of Follow-up

Time course of superimposed cumulative individual values of percentage excess body mass index (BMI) loss over the 5-year period after surgery. Circles indicate mean values at 1, 2, 3, 4, and 5 years after surgery. Missing values were imputed for number of participants at each time point. Body mass index is calculated as weight in kilograms divided by height in meters squared.