Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial
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Importance: Laparoscopic sleeve gastrectomy for treatment of morbid obesity has increased substantially despite the lack of long-term results compared with laparoscopic Roux-en-Y gastric bypass. Objective: To determine whether laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass are equivalent for weight loss at 5 years in patients with morbid obesity. Design, Setting, and Participants: The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015). Interventions: Laparoscopic sleeve gastrectomy (n = 121) or laparoscopic Roux-en-Y gastric bypass (n = 119). Main Outcomes and Measures: The primary end point was weight loss evaluated by percentage excess weight loss. Prespecified equivalence margins for the clinical significance of weight loss differences between gastric bypass and sleeve gastrectomy were -9% to +9% excess weight loss. Secondary end points included resolution of comorbidities, improvement of quality of life (QOL), all adverse events (overall morbidity), and mortality. Results: Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n = 15/41) after sleeve gastrectomy and in 45% (n = 18/40) after gastric bypass (P > .99). Medication for dyslipidemia was discontinued in 47% (n = 14/30) after sleeve gastrectomy and 60% (n = 24/40) after gastric bypass (P = .15) and for hypertension in 29% (n = 20/68) and 51% (n = 37/73) (P = .02), respectively. There was no statistically significant difference in QOL between groups (P = .85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n = 23) for sleeve gastrectomy and 26% (n = 31) for gastric bypass (P = .19). Conclusions and Relevance: Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins. Trial Registration: clinicaltrials.gov Identifier: NCT00793143.
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Remission of pre-existing gastroesophageal reflux after RYGB versus sleeve gastrectomy had an absolute difference of -0.36 (95% CI -0.57 to -0.15).
“Remission of pre-existing gastroesophageal reflux (absolute difference − 0.36, 95% CI − 0.57 to − 0.15) and de novo gastroesophageal reflux was more often seen after sleeve gastrectomy (absolute difference − 0.31%, 95% CI − 0.08% to − 0.54%) (moderate and low certainty of evidence).”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [104]
De novo gastroesophageal reflux was more often seen after sleeve gastrectomy than RYGB (absolute difference -0.31%, 95% CI -0.08% to -0.54%).
“Remission of pre-existing gastroesophageal reflux (absolute difference − 0.36, 95% CI − 0.57 to − 0.15) and de novo gastroesophageal reflux was more often seen after sleeve gastrectomy (absolute difference − 0.31%, 95% CI − 0.08% to − 0.54%) (moderate and low certainty of evidence).”
From Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP (2020) · cites this paper as [104]
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- Authors
- Salminen, P., Helmiö, M., Ovaska, J., Juuti, A., Leivonen, M., Peromaa-Haavisto, P., Hurme, S., Soinio, M., Nuutila, P., & Victorzon, M.
- Affiliations
- University of Turku (FI)
- University of Helsinki (FI)
- Vaasa Central Hospital (FI)
- Turku University Hospital (FI)
- Corresponding author
- Salminen, Paulina
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2018-01-16
- Volume
- 319
- Issue
- 3
- Pages
- 241
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC5833550
- OpenAlex
- W2784062190
- Cited by
- 946
- References
- 43
- Citations by year
- 2026: 61 · 2025: 74 · 2024: 106 · 2023: 113 · 2022: 120 · 2021: 128 · 2020: 162 · 2019: 122 · 2018: 57 · 2016: 1 · 2013: 1
- FWCI
- 121.85
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Mary och Georg C. Ehrnrooths Stiftelse
- Turun Yliopistollinen Keskussairaala
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Surgery › Minimally Invasive Surgical Techniques
- Health Sciences › Medicine › Surgery › Body Contouring and Surgery
- Keywords
- laparoscopic sleeve gastrectomy, laparoscopic Roux-en-Y gastric bypass, morbid obesity, weight loss, excess weight loss, bariatric surgery, type 2 diabetes remission, quality of life, surgical morbidity, mortality, long-term outcomes, equivalence trials, obesity-related comorbidities
- MeSH terms
- Adolescent, Adult, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Gastrectomy, Humans, Hyperlipidemias, Hypertension, Male, Middle Aged, Obesity, Morbid, Laparoscopy, Postoperative Complications, Quality of Life, Gastric Bypass, Weight Loss, Treatment Outcome, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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