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).

Autor: Biter LU; Department of Surgery, Tulp Medisch Centrum, Zwijndrecht, the Netherlands.; Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands., 't Hart JW; Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.; Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands., Noordman BJ; Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.; Department of Surgery, Erasmus Medical Centre, Rotterdam, the Netherlands., Smulders JF; Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands., Nienhuijs S; Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands., Dunkelgrün M; Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands., Zengerink JF; Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands., Birnie E; Department of Statistics and Education, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.; Department of Genetics, University Medical Centre Groningen, Groningen, the Netherlands., Friskes IA; Department of Surgery, Groene Hart Hospital, Gouda, the Netherlands., Mannaerts GH; Department of Surgery, Mediclinic Al Ain / Abu Dhabi, United Arab Emirates.; Department of Surgery, Gulf Specialized Hospital, Muscat, Oman., Apers JA; Department of Surgery, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.
Jazyk: angličtina
Zdroj: The Lancet regional health. Europe [Lancet Reg Health Eur] 2024 Jan 22; Vol. 38, pp. 100836. Date of Electronic Publication: 2024 Jan 22 (Print Publication: 2024).
DOI: 10.1016/j.lanepe.2024.100836
Abstrakt: 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  < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%-24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%-27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, -5.2% to -1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) ( P  = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) ( P  < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered.
Interpretation: In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups.
Funding: Not applicable.
Competing Interests: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr. SN reported receiving a Medtronic Educational Grant to the Catharina Obesity centre. No other authors reported disclosures.
(© 2024 The Author(s).)
Databáze: MEDLINE
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