SM-BOSS (10-year follow-up)
Trial question
What is the long-term effect of Roux-en-Y gastric bypass versus sleeve gastrectomy in patients with severe obesity?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
72.0% female
28.0% male
N = 217
217 patients (156 female, 61 male).
Inclusion criteria: adults aged 18-65 years with a BMI > 40 kg/m² or with BMI > 35 kg/m² and ≥ 1 obesity-related comorbidity.
Key exclusion criteria: previous bariatric surgery; severe GERD; large hiatal hernia; IBD.
Interventions
N=110 Roux-en-Y gastric bypass (surgical procedure to create a small stomach pouch and reroute the intestines).
N=107 sleeve gastrectomy (surgical removal of a portion of the stomach to limit food intake).
Primary outcome
Percentage of patients achieving excess body mass index loss at 10 years, per-protocol population
65.9%
56.1%
65.9 %
49.4 %
33.0 %
16.5 %
0.0 %
Roux-en-Y gastric
bypass
Sleeve
gastrectomy
Significant
increase ▲
NNT = 10
Significant increase in the percentage of patients achieving excess BMI loss at 10 years, per-protocol population (65.9% vs. 56.1%; AD 9.8%, 95% CI 0.07 to 19.53).
Secondary outcomes
No significant difference in total weight loss at 10 years (27.7% vs. 25.5%; AD 2.2%, 95% CI -2.55 to 6.95).
No significant difference in de novo GERD at 10 years (7.9% vs. 32.3%; ARD -24.5, 95% CI -46.44 to 1.67).
No significant difference in complete remission from T2DM at 10 years (71.4% vs. 61.1%; AD 10.3%, 95% CI -49.7 to 34.3).
Safety outcomes
No significant difference in complications.
Significant difference in conversion rates because of suboptimal clinical response or GERD (5.5% vs. 29.9%).
Conclusion
In adults aged 18-65 years with a BMI > 40 kg/m² or with BMI > 35 kg/m² and ≥ 1 obesity-related comorbidity, Roux-en-Y gastric bypass was superior to sleeve gastrectomy with respect to the percentage of patients achieving excess BMI loss at 10 years, per-protocol population.
Reference
Marko Kraljevic, Julian Süsstrunk, Bettina Karin Wölnerhanssen et al. Long-Term Outcomes of Laparoscopic Roux-en-Y Gastric Bypass vs Laparoscopic Sleeve Gastrectomy for Obesity: The SM-BOSS Randomized Clinical Trial. JAMA Surg. 2025 Apr 1;160(4):369-377.
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