The results of a large-scale, multicenter randomized controlled trial showed that Roux-en-Y gastric bypass may be more effective compared to sleeve gastrectomy and adjustable gastric banding in patients with severe obesity.
In the By-Band-Sleeve study, published in The Lancet Diabetes & Endocrinology and conducted across 12 UK hospitals with 1,346 participants, researchers found that Roux-en-Y gastric bypass (RYGB) resulted in superior weight loss and quality-of-life outcomes compared with the other procedures at 3 years post-randomization. They also determined that RYGB was the most cost-effective option among the three interventions.
"Based on this evidence, it is recommended that patients electing to have metabolic and bariatric surgery are advised to have [RYGB]. Where contraindicated or unfeasible, sleeve gastrectomy should be offered. This evidence does not support adjustable gastric band as standard treatment for severe obesity," the study authors emphasized.
The pragmatic, open-label trial included adults (18 years and older) meeting national criteria for metabolic and bariatric surgery, with a mean age of 47.3 years, mean weight of 129.7 kg, and mean body mass index of 46.4 kg/m². The study population was 76% female, with 31% having diabetes at baseline.
At 3 years, 68% of participants in the RYGB group achieved at least 50% excess weight loss compared with only 41% in the sleeve gastrectomy (SG) group and 25% in the adjustable gastric banding (AGB) group. Mean percentage total weight loss was –26.8% for RYGB, –19.4% for SG, and –14.0% for AGB.
Quality-of-life measurements using the EQ-5D-5L utility score showed similar patterns, with mean scores of 0.72 for RYGB, 0.68 for SG, and 0.62 for AGB. The mean difference between RYGB and AGB was 0.08 (98% confidence interval [CI] = 0.04–0.12), whereas SG vs AGB showed a difference of 0.05 (98% CI = 0.01–0.09).
The research began as a two-group trial comparing RYGB and AGB but expanded to include SG 2.6 years after the study opened, when SG became widely used in the United Kingdom. This design allowed the researchers to evaluate all three major bariatric surgery options under rigorous conditions.
While SG showed fewer adverse events from 30 days post-surgery to 3 years compared with RYGB and AGB, the proportion of serious adverse events was similar between the SG and RYGB groups. Complications related to technical aspects of surgery included internal hernia repairs after RYGB (4%), leaks from the staple line following SG (1%), and revision operations after AGB (14%).
"Our finding that [SG] is associated with [RYGB] at 3 years distinguishes this trial from previous randomized trials comparing [SG] and [RYGB], although our findings are more similar to nonrandomized data," the study authors noted.
HbA1c of less than 48 mmol/mol at 3 years was reached by 91% of RYGB participants, 88% of SG participants, and 82% of AGB participants. Among those with diabetes at baseline, the corresponding percentages were 76%, 62%, and 50%, respectively.
The researchers acknowledged that "understanding long-term outcomes and comparing metabolic and bariatric surgery with obesity management medications is needed to guide evidence-based practice in this rapidly evolving field." They highlighted the need for future research to assess the long-term benefits and risks of each procedure.
This comprehensive study represented one of the largest randomized trials in bariatric surgery to date and is expected to significantly impact clinical practice by challenging the trend toward SG that has occurred despite limited comparative effectiveness data.
Disclosures can be found in the published study.
