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BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy
Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden.
Linköping University, Department of Clinical and Experimental Medicine, Division of Surgery, Orthopedics and Oncology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Surgery in Norrköping.
Natl Inst Hlth and Welf, Finland.
Mora Hosp, Sweden; Karolinska Inst, Sweden.
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2019 (English)In: Contemporary Clinical Trials, ISSN 1551-7144, E-ISSN 1559-2030, Vol. 84, article id 105809Article in journal (Refereed) Published
Abstract [en]

Background

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.

Method

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.

Conclusions

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.

Place, publisher, year, edition, pages
Elsevier, 2019. Vol. 84, article id 105809
Keywords [en]
Laparoscopic gastric bypass; Laparoscopic sleeve gastrectomy; Randomized clinical trial; Registry study
National Category
Orthopaedics
Identifiers
URN: urn:nbn:se:liu:diva-161416DOI: 10.1016/j.cct.2019.07.001ISI: 000488654600008PubMedID: 31279778OAI: oai:DiVA.org:liu-161416DiVA, id: diva2:1367039
Note

Funding Agencies|Swedish Research CouncilSwedish Research Council; Erling Persson Family Foundation; ALF Vastra G8taland region

Available from: 2019-10-31 Created: 2019-10-31 Last updated: 2019-11-07Bibliographically approved

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Olbers, TorstenWirén, Mikael
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Division of Surgery, Orthopedics and OncologyFaculty of Medicine and Health SciencesDepartment of Surgery in Norrköping
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