In a significant development in obesity treatment research, a recent phase III randomized controlled trial (RCT) conducted by researchers from the Netherlands and published in The Lancet Regional Health – Europe has provided new insights into the long-term effects of two prevalent metabolic surgeries: sleeve gastrectomy and Roux-en-Y gastric bypass.
Key Findings
The study, known as the Sleeve Bypass trial, aimed to assess and compare the long-term weight loss and health outcomes of the two procedures in individuals with severe obesity (grades 2 and 3). The researchers discovered that while both surgeries resulted in substantial and clinically comparable excess body mass index (BMI) loss, Roux-en-Y gastric bypass led to significantly higher total weight loss (TWL). Additionally, Roux-en-Y gastric bypass showed superior benefits in managing dyslipidemia and reducing gastroesophageal reflux disease (GERD).
Study Background
Obesity is a pressing global health issue, prompting the need for effective treatment strategies. Metabolic surgeries such as Roux-en-Y gastric bypass and sleeve gastrectomy have been recognized as highly effective interventions. However, previous studies have presented conflicting results regarding their relative advantages, particularly in terms of weight loss and the remission of type 2 diabetes (T2D).
While sleeve gastrectomy is less technically challenging and more commonly performed, concerns about its irreversibility and the risk of GERD persist. This study aimed to provide clearer evidence by directly comparing the clinical outcomes of both procedures.
Study Details
The trial involved 628 patients eligible for metabolic surgery, randomly assigned to undergo either sleeve gastrectomy (312 patients) or Roux-en-Y gastric bypass (316 patients). The participants, with a mean age of 43 years and an average baseline BMI of 43.5 kg/m², were predominantly female (81.8%).
Patients with severe GERD, hiatal hernia, previous major abdominal surgeries, or those unable to provide informed consent were excluded. The primary outcome measured was weight loss, assessed by percentage excess BMI loss five years post-surgery. Secondary outcomes included total weight loss, comorbidity resolution, surgical duration, hospital stay, and quality of life.
Results
The study found a mean excess BMI loss of 67.1% for Roux-en-Y gastric bypass compared to 58.8% for sleeve gastrectomy. Although this difference was within the equivalence margin, Roux-en-Y gastric bypass resulted in a higher TWL (26%) than sleeve gastrectomy (22.5%) five years post-surgery.
Both procedures significantly improved obesity-related comorbidities. However, dyslipidemia showed greater improvement with Roux-en-Y gastric bypass (83%) than sleeve gastrectomy (62%). Conversely, sleeve gastrectomy had a higher incidence of new-onset GERD (16%) compared to Roux-en-Y gastric bypass (4%).
While minor complications were more frequent with Roux-en-Y gastric bypass, major complications, hypertension, T2D, obstructive sleep apnea (OSA), joint pain, and quality of life improvements did not differ significantly between the two groups.
Limitations and Conclusion
The Sleeve Bypass trial, the largest of its kind, underscores the efficacy of metabolic surgery in managing obesity. However, the study faced limitations such as a relatively large equivalence margin, the exclusion of baseline BMI effects on BMI loss, and potential selection bias.
In conclusion, the trial’s findings support the use of both sleeve gastrectomy and Roux-en-Y gastric bypass in treating obesity, highlighting their respective advantages and potential drawbacks. These insights are invaluable for clinicians and policymakers, aiding in informed decision-making and ultimately improving public health outcomes.
