Laparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial.

Abstract

There are very few randomised, blinded trials comparing laparoscopic sleeve gastrectomy (LSG) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) in achieving remission of type 2 diabetes (T2D), particularly silastic ring (SR)-LRYGB. We compared the effectiveness of (LSG) versus SR-LRYGB among patients with T2D and morbid obesity. Prospective, randomised, parallel, 2-arm, blinded clinical trial conducted in a single Auckland (New Zealand) centre. Eligible patients aged 20-55years, T2D of at least 6months duration and BMI 35-65kg/m2 were randomised 1:1 to LSG (n=58) or SR-LRYGB (n=56) using random number codes disclosed after anaesthesia induction. Primary outcome was T2D remission defined by different HbA1c thresholds at 1year. Secondary outcomes included weight loss, quality of life, anxiety and depressive symptoms, post-operative complications and mortality. Mean±standard deviation (SD) pre-operative BMI was 42.5±6.2kg/m2, HbA1c 63±16mmol/mol (30% insulin-treated, 28% had diabetes duration over 10years). Proportions achieving HbA1c ≤38mmol/mol, <42mmol/mol, <48mmol/mol and <53mmol/mol without diabetes medication at 1year in SR-LRYGB vs LSG were 38 vs 43% (p=0.56), 52 vs 49% (p=0.85), 75 vs 72% (p=0.83) and 80 vs 77% (p=0.82), respectively. Mean±SD % total weight loss at 1year was greater after SR-LRYGB than LSG: 32.2±7.7 vs 27.1±7.5%, respectively (p<0.001). Gastrointestinal complications were more frequent after SR-LRYGB (including 3 ulcers, 1 anastomotic leak, 1 abdominal bleeding). Quality of life and depression symptoms improved significantly in both groups. Despite significantly greater weight loss after SR-LRYGB, there was similar T2D remission and psychosocial improvement after LSG and SR-LRYGB at 1year. Prospectively registered at Australia and New Zealand Clinical Trials Register (ACTRN 12611000751976) and retrospectively registered at Clinical Trials (NCT1486680).