Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass)Research in context
In: The Lancet Regional Health. Europe, Jg. 38 (2024-03-01), Heft 100836-
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Summary: Background: Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects. Methods: This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was −13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900. Findings: 628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%–63%] after sleeve gastrectomy and 67.1% [95% CI, 63%–71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, −12.5% to −4.0%]). This was within the predefined margin (P
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Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass)Research in context
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Autor/in / Beteiligte Person: | L Ulas Biter ; Judith WH. ‘t Hart ; Noordman, Bo J. ; J Frans Smulders ; Nienhuijs, Simon ; Dunkelgrün, Martin ; Zengerink, Johannes F. ; Birnie, Erwin ; Irene AM. Friskes ; Guido HH. Mannaerts ; Apers, Jan A. |
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Zeitschrift: | The Lancet Regional Health. Europe, Jg. 38 (2024-03-01), Heft 100836- |
Veröffentlichung: | Elsevier, 2024 |
Medientyp: | academicJournal |
ISSN: | 2666-7762 (print) |
DOI: | 10.1016/j.lanepe.2024.100836 |
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