Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.

摘要: Importance Laparoscopic sleeve gastrectomy for treatment of morbid obesity has increased substantially despite the lack long-term results compared with laparoscopic Roux-en-Y gastric bypass. Objective To determine whether and bypass are equivalent weight loss at 5 years in patients obesity. Design, Setting, Participants The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 Finland. enrolled 240 morbidly obese aged 18 to 60 years, who were randomly assigned or a 5-year follow-up period (last follow-up, October 14, 2015). Interventions (n = 121) (n = 119). Main Outcomes Measures primary end point evaluated by percentage excess loss. Prespecified margins significance differences between −9% +9% Secondary points included resolution comorbidities, improvement quality life (QOL), all adverse events (overall morbidity), mortality. Results Among (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9,[SD, 6.0]; 69.6% women), 80.4% completed follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, 70.8% hypertension. estimated 49% (95% CI, 45%-52%) after 57% 53%-61%) (difference, 8.2 units [95% 3.2%-13.2%], higher group) did not meet criteria equivalence. Complete partial remission diabetes seen 37% (n = 15/41) 45% (n = 18/40) (P > .99). Medication dyslipidemia discontinued 47% (n = 14/30) 60% (n = 24/40) (P = .15) hypertension 29% (n = 20/68) 51% (n = 37/73) (P = .02), respectively. There no statistically significant difference QOL groups (P = .85) treatment-related overall morbidity rate 19% (n = 23) 26% (n = 31) (P = .19). Conclusions Relevance obesity, use terms years. Although associated greater significant, based on prespecified margins. Trial Registration clinicaltrials.gov Identifier:NCT00793143