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Randomized Controlled Trial
. 2024 Jan 2;7(1):e2353141.
doi: 10.1001/jamanetworkopen.2023.53141.

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

Suzanne Hedberg  1   2 , Anders Thorell  3   4 , Johanna Österberg  5   6 , Markku Peltonen  7 , Ellen Andersson  8   9 , Erik Näslund  3 , Jens Kristoffer Hertel  10 , Marius Svanevik  10   11 , Erik Stenberg  12 , Martin Neovius  13 , Ingmar Näslund  12 , Mikael Wirén  3   4 , Johan Ottosson  12 , Torsten Olbers  8   14 ; BEST Study Group
Collaborators, Affiliations
Randomized Controlled Trial

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

Suzanne Hedberg et al. JAMA Netw Open. .

Erratum in

  • Error in Author Affiliations.
    [No authors listed] [No authors listed] JAMA Netw Open. 2024 Mar 4;7(3):e248600. doi: 10.1001/jamanetworkopen.2024.8600. JAMA Netw Open. 2024. PMID: 38546653 Free PMC article. No abstract available.

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Österberg reported receiving personal fees from Baxter, Ethicon, and Mölnlycke outside the submitted work. Dr Stenberg reported receiving personal fees from Johnson & Johnson and the Swedish National Board of Health and Welfare outside the submitted work. Dr Neovius reported receiving grants from the Swedish Research Council and the Swedish Research Council for Health, Working Life and Welfare during the conduct of the study. Dr Ottosson reported serving on the advisory board and lecturing for Novo Nordisk outside the submitted work. Dr Olbers reported receiving educational activities funds from Novo Nordisk and Johnson & Johnson outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flowchart for the Bypass Equipoise Sleeve Trial
GERD indicates gastroesophageal reflux disease; RYGB, Roux-en-Y gastric bypass; UGI, upper gastrointestinal tract. aEligible but randomized without digital randomization; detailed exclusion data were not captured.
Figure 2.
Figure 2.. Diagnoses at Reoperation for Complications Until 30 Days Postoperatively After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass
Intraoperative complications are not shown (Table 2). The total numbers of patients undergoing subsequent operations were 14 for sleeve gastrectomy and 23 for Roux-en-Y gastric bypass (some patients had >1 diagnosis at reoperation). One subcutaneous abscess was incised with the patient under local anesthesia. The 2 patients who underwent gastroscopy in general anesthesia are not shown. aRevision surgery indicates sleeve gastrectomy revised to Roux-en-Y gastric bypass.
Figure 3.
Figure 3.. Risk (Adjusted Odds Ratio After Multivariate Logistic Regression) of Any Adverse Event and Serious Adverse Events
There were no statistically significant differences between sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) in these analyses. BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared).
See this image and copyright information in PMC

References

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