BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy

• Published in: Contemporary clinical trials Vol. 84; p. 105809
• Main Authors: Hedberg, Suzanne, Olbers, Torsten, Peltonen, Markku, Österberg, Johanna, Wirén, Mikael, Ottosson, Johan, Thorell, Anders
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2019
• Subjects: adult; alcohol; alcohol abuse; Anastomosis, Roux-en-Y - adverse effects; Anastomosis, Roux-en-Y - methods; Anastomosis, Roux-en-Y - mortality; Body Mass Index; body weight loss; Comorbidity; controlled study; diabetes mellitus; female; follow up; Gastrectomy - adverse effects; Gastrectomy - methods; Gastrectomy - mortality; gastric bypass surgery; Gastroenterologi; Gastroenterology and Hepatology; hospitalization; human; Humans; intermethod comparison; Kirurgi; Laparoscopic gastric bypass; Laparoscopic sleeve gastrectomy; laparoscopic surgery; Laparoscopy; major clinical study; male; Medicin och hälsovetenskap; Multicenter Studies as Topic; multicenter study; non-inferiority trial; obese patient; obesity; Obesity, Morbid - surgery; outpatient care; Postoperative Complications - epidemiology; Quality of Life; Randomized clinical trial; randomized controlled trial; Randomized Controlled Trials as Topic; Registry study; Reoperation; Scandinavian and Nordic Countries; study design; Surgery; Scandinavian and Nordic Countries; Laparoscopic gastric bypass; Randomized clinical trial; Laparoscopic sleeve gastrectomy; Registry study
• ISSN: 1551-7144; 1559-2030; 1559-2030
• DOI: 10.1016/j.cct.2019.07.001

Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods. BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups. As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT 02767505.