Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial.
Adult
Anastomosis, Roux-en-Y
/ adverse effects
Anastomosis, Surgical
/ adverse effects
Body Mass Index
Diarrhea
/ etiology
Female
France
/ epidemiology
Gastric Bypass
/ adverse effects
Humans
Male
Metabolism
/ physiology
Middle Aged
Obesity, Morbid
/ surgery
Prospective Studies
Steatorrhea
/ etiology
Treatment Outcome
Weight Loss
/ physiology
Journal
Lancet (London, England)
ISSN: 1474-547X
Titre abrégé: Lancet
Pays: England
ID NLM: 2985213R
Informations de publication
Date de publication:
30 Mar 2019
30 Mar 2019
Historique:
received:
05
02
2019
revised:
15
02
2019
accepted:
20
02
2019
pubmed:
11
3
2019
medline:
7
5
2019
entrez:
11
3
2019
Statut:
ppublish
Résumé
One anastomosis gastric bypass (OAGB) is increasingly used in the treatment of morbid obesity. However, the efficacy and safety outcomes of this procedure remain debated. We report the results of a randomised trial (YOMEGA) comparing the outcomes of OAGB versus standard Roux-en-Y gastric bypass (RYGB). This prospective, multicentre, randomised non-inferiority trial, was held in nine obesity centres in France. Patients were eligible for inclusion if their body-mass index (BMI) was 40 kg/m From May 13, 2014, to March 2, 2016, of 261 patients screened for eligibility, 253 (97%) were randomly assigned to OAGB (n=129) or RYGB (n=124). Five patients did not undergo their assigned surgery, and after undergoing their surgery 14 were excluded from the per-protocol analysis (seven due to pregnancy, two deaths, one withdrawal, and four revisions from OAGB to RYGB) In the per-protocol population (n=117 OAGB, n=117 RYGB), mean age was 43·5 years (SD 10·8), mean BMI was 43·9 kg/m OAGB is not inferior to RYGB regarding weight loss and metabolic improvement at 2 years. Higher incidences of diarrhoea, steatorrhoea, and nutritional adverse events were observed with a 200 cm biliopancreatic limb OAGB, suggesting a malabsorptive effect. French Ministry of Health.
Sections du résumé
BACKGROUND
BACKGROUND
One anastomosis gastric bypass (OAGB) is increasingly used in the treatment of morbid obesity. However, the efficacy and safety outcomes of this procedure remain debated. We report the results of a randomised trial (YOMEGA) comparing the outcomes of OAGB versus standard Roux-en-Y gastric bypass (RYGB).
METHODS
METHODS
This prospective, multicentre, randomised non-inferiority trial, was held in nine obesity centres in France. Patients were eligible for inclusion if their body-mass index (BMI) was 40 kg/m
FINDINGS
RESULTS
From May 13, 2014, to March 2, 2016, of 261 patients screened for eligibility, 253 (97%) were randomly assigned to OAGB (n=129) or RYGB (n=124). Five patients did not undergo their assigned surgery, and after undergoing their surgery 14 were excluded from the per-protocol analysis (seven due to pregnancy, two deaths, one withdrawal, and four revisions from OAGB to RYGB) In the per-protocol population (n=117 OAGB, n=117 RYGB), mean age was 43·5 years (SD 10·8), mean BMI was 43·9 kg/m
INTERPRETATION
CONCLUSIONS
OAGB is not inferior to RYGB regarding weight loss and metabolic improvement at 2 years. Higher incidences of diarrhoea, steatorrhoea, and nutritional adverse events were observed with a 200 cm biliopancreatic limb OAGB, suggesting a malabsorptive effect.
FUNDING
BACKGROUND
French Ministry of Health.
Identifiants
pubmed: 30851879
pii: S0140-6736(19)30475-1
doi: 10.1016/S0140-6736(19)30475-1
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02139813']
Types de publication
Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1299-1309Commentaires et corrections
Type : CommentIn
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Type : ErratumIn
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Informations de copyright
Copyright © 2019 Elsevier Ltd. All rights reserved.