Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial.

Ellen Andersson, Suzanne Hedberg, Mikael Wirén, Johan Ottosson, Ingmar Näslund, Torsten Olbers, Martin Neovius, Erik Näslund, Erik Stenberg, Markku Peltonen, Anders Thorell, Marius Svanevik, Jens Kristoffer Hertel, Johanna Österberg

Journal: JAMA network open 2024;7(1):e2353141

PMID: 38289603

Free Full Text on PubMed Central View on PubMed

Abstract

IMPORTANCE

Laparoscopic sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (RYGB) are widely used bariatric procedures for which comparative efficacy and safety remain unclear.

OBJECTIVE

To compare perioperative outcomes in SG and RYGB.

DESIGN, SETTING, AND PARTICIPANTS

In this registry-based, multicenter randomized clinical trial (Bypass Equipoise Sleeve Trial), baseline and perioperative data for patients undergoing bariatric surgery from October 6, 2015, to March 31, 2022, were analyzed. Patients were from university, regional, county, and private hospitals in Sweden (n = 20) and Norway (n = 3). Adults (aged ≥18 years) eligible for bariatric surgery with body mass indexes (BMIs; calculated as weight in kilograms divided by height in meters squared) of 35 to 50 were studied.

INTERVENTIONS

Laparoscopic SG or RYGB.

MAIN OUTCOMES AND MEASURES

Perioperative complications were analyzed as all adverse events and serious adverse events (Clavien-Dindo grade >IIIb). Ninety-day mortality was also assessed.

RESULTS

A total of 1735 of 14 182 eligible patients (12%; 1282 [73.9%] female; mean (SD) age, 42.9 [11.1] years; mean [SD] BMI, 40.8 [3.7]) were included in the study. Patients were randomized and underwent SG (n = 878) or RYGB (n = 857). The mean (SD) operating time was shorter in those undergoing SG vs RYGB (47 [18] vs 68 [25] minutes; P < .001). The median (IQR) postoperative hospital stay was 1 (1-1) day in both groups. The 30-day readmission rate was 3.1% after SG and 4.0% after RYGB (P = .33). There was no 90-day mortality. The 30-day incidence of any adverse event was 40 (4.6%) and 54 (6.3%) in the SG and RYGB groups, respectively (odds ratio, 0.71; 95% CI, 0.47-1.08; P = .11). Corresponding figures for serious adverse events were 15 (1.7%) for the SG group and 23 (2.7%) for the RYGB group (odds ratio, 0.63; 95% CI, 0.33-1.22; P = .19).

CONCLUSIONS AND RELEVANCE

This randomized clinical trial of 1735 patients undergoing primary bariatric surgery found that both SG and RYGB were performed with a low perioperative risk without clinically significant differences between groups.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02767505.

Address: Department of Surgery, Department of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; Department of Surgery (Östra Sjukhuset), Sahlgrenska University Hospital, Gothenburg, Sweden.; Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.; Department of Surgery, Ersta Hospital, Stockholm, Sweden.; Department of Surgery, Mora Hospital, Mora, Sweden.; Department of Clinical Sciences, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.; Finnish Institute for Health and Welfare, Helsinki, Finland.; Department of Surgery, Vrinnevi Hospital, Norrköping, Sweden.; Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.; Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.; Department of Endocrinology, Obesity, and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Endocrinology, Obesity, and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Surgery, Vestfold Hospital Trust, Tønsberg, Norway.; Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.; Division of Clinical Epidemiology, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden.; Department of Surgery, Vrinnevi Hospital, Norrköping, Sweden.; Wallenberg Centre for Molecular Medicine, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.

DOI: 10.1001/jamanetworkopen.2023.53141