By-Band-Sleeve (RYGB vs. gastric banding)
Trial question
Is Roux-en-Y gastric bypass surgery superior to adjustable gastric banding in patients with severe obesity?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
75.0% female
25.0% male
N = 926
926 patients (699 female, 227 male).
Inclusion criteria: patients with severe obesity meeting criteria for metabolic and bariatric surgery.
Key exclusion criteria: previous gastric surgery or surgery for severe obesity; large abdominal ventral hernia; pregnancy; Crohn's disease; liver cirrhosis and portal hypertension; systemic lupus erythematosis; known silicone allergy; hiatus hernia > 5 cm.
Interventions
N=462 Roux-en-Y gastric bypass (surgical intervention in which a small pouch is made in the top of the stomach and a loop of bowel is connected to the pouch to bypass the rest of the stomach).
N=464 adjustable gastric banding (surgical intervention in which a band and port is fitted using a laparoscopic technique).
Primary outcome
Percentage of patients achieving ≥ 50% excess weight loss at 3 years
68%
25%
68.0 %
51.0 %
34.0 %
17.0 %
0.0 %
Roux-en-Y gastric
bypass
Adjustable gastric
banding
Significant
increase ▲
NNT = 2
Significant increase in the percentage of patients achieving ≥ 50% excess weight loss at 3 years (68% vs. 25%; AD 41%, 97.5% CI 33.9 to 47.5).
Secondary outcomes
Significant increase in EuroQol-5 Dimension at 3 years (71.8 points vs. 61.9 points; MD 7.9, 97.5% CI 4 to 11.7).
Significant increase in total weight loss at 3 years (26.8% vs. 14%; MD 12.7, 97.5% CI 10.4 to 14.9).
Significant decrease in BMI at 3 years (34 kg/m² vs. 39.6 kg/m²; MD -5.93, 97.5% CI -7.02 to -4.85).
Safety outcomes
No significant differences in adverse events at 30 days, adverse events at 3 years.
Conclusion
In patients with severe obesity meeting criteria for metabolic and bariatric surgery, Roux-en-Y gastric bypass was superior to adjustable gastric banding with respect to the percentage of patients achieving ≥ 50% excess weight loss at 3 years.
Reference
By-Band-Sleeve Collaborative Group. Roux-en-Y gastric bypass, adjustable gastric banding, or sleeve gastrectomy for severe obesity (By-Band-Sleeve): a multicentre, open label, three-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2025 May;13(5):410-426.
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