Prospective, Multicentric, Randomized Study, between Sleeve Gastrectomy and Roux-en-Y Gastric Bypass with 3 years Follow-up (efficiency, complications, quality of life) for Morbid Obesity at Risk

Objective: To demonstrate that sleeve gastrectomy (SG) improves the benefit/risk ratio of Roux-en-Y Gastric Bypass (RYGB) concerning the loss of weight, the improvement of comorbidities, and the quality of life, for the treatment of morbid obesity with 36 months follow-up.
Methods: Prospective, multicentric, randomized study between SG and RYGBP for the morbid obese patient with BMI superior to 45 kg/m2, or superior to 40 kg/m2 if history of gastric banding. The study tested 2 hypotheses: A hypothesis of difference on the frequency of morbi-mortality events, and a non-inferiority hypothesis of SG on the reduction of excess weight greater than 50% at 36 months.
Results: 40 patients were included (25 SG, 15 RYGBP). The mean age was 43.1 ± 9.2 years, with 82.5% of women, and average BMI of 49.0 ± 6.1 kg/m2. Concerning the composite endpoint of morbi-mortality, there was no significant difference between RYGBP and SG (p= 0.0572). The loss of excess weight greater than 50% at 36 months was 78.6% and 63.6% for RYGBP and SG respectively, let be a difference of 14.9% CI 95% (-14.5%; 44.4%). The superior border of the CI 95% of 44.4% was superior to 15% (margin of non-inferiority). It does not allow to conclude the non-inferiority of SG on the reduction of the excess weight at 36 months. There was no statistical significant difference between RYGBP and SG on the improvement of comorbidities and quality of life.
Conclusions: The SG seems so effective and safe as RYGP at 36 months follow up.