학술논문
Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol.
Document Type
Academic Journal
Author
Robert M; Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, CarMeN Laboratory, INSERM 1060, Université Claude Bernard Lyon 1, Lyon, France.; Poghosyan T; Department of Digestive, Oncologic and Bariatric Surgery; Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Inserm UMRS 1149, Université de Paris, Paris, France tigran.poghosyan@aphp.fr.; Delaunay D; Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.; Pelascini E; Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.; Iceta S; Department of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.; Sterkers A; Department of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, France.; Barsamian C; Department of Nutrition, Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, France.; Khamphommala L; Department of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, France.; Bin Dorel S; Clinical Research Unit, Hospices Civils de Lyon, Lyon, France.; Maucort-Boulch D; Department of Biostatistics, Hospices Civils de Lyon, Hôpital Edouard Herriot, Université Lyon 1, Lyon, France.; Czernichow S; Department of Nutrition, Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, France.; Equipe METHODS, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS-UMR1153) Inserm, Paris, France.; Disse E; Department of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.; CarMeN Lab, INSERM U1060, Lyon, France.
Source
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Subject
Language
English
Abstract
Introduction: Despite the non-negligible weight loss failure rate at midterm, Roux-en-Y gastric bypass (RYGB) remains the reference procedure in the treatment of morbid obesity with metabolic comorbidities. A recently emerged procedure, the single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), could be more effective on weight loss with similar morbidity and lower weight loss failure rate than RYGB. We propose the first randomised, open, multicentre superiority trial comparing the SADI-S to RYGB (SADISLEEVE).
Methods and Analysis: The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage. The secondary objectives are the evaluation of nutritional status, metabolic outcomes, overall complication rates and quality of life, within 2 years after surgery. Key inclusion criteria are obese patients with body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m 2 with at least one comorbid condition and candidate to a first bariatric procedure or after failure of sleeve gastrectomy. Patients randomised by minimisation in two arms, based on centre, surgery as a revisional procedure, presence of type 2 diabetes and BMI >50 kg/m 2 will be included over 2 years.A sample size of 166 patients in each group will have a power of 90% to detect a probability of 0.603 that excess weight loss in the RYGB arm is less than excess weight loss in the SADI-S arm with a 5% two-sided significance level. With a drop-out rate of 10%, it will be necessary to include 183 patients per group.
Ethics and Dissemination: The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). Study was also approved by the French national agency for drug safety (2018061500148). Results will be reported in peer-reviewed scientific journals.
Trial Registration Number: NCT03610256.
Competing Interests: Competing interests: DM-B reports personal fees from Maat Pharma outside of the submitted work. MR reports fees as a consultant from Medtronic and fees as an expert speaker from Gore outside of the submitted work.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Methods and Analysis: The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage. The secondary objectives are the evaluation of nutritional status, metabolic outcomes, overall complication rates and quality of life, within 2 years after surgery. Key inclusion criteria are obese patients with body mass index (BMI) ≥40 kg/m
Ethics and Dissemination: The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). Study was also approved by the French national agency for drug safety (2018061500148). Results will be reported in peer-reviewed scientific journals.
Trial Registration Number: NCT03610256.
Competing Interests: Competing interests: DM-B reports personal fees from Maat Pharma outside of the submitted work. MR reports fees as a consultant from Medtronic and fees as an expert speaker from Gore outside of the submitted work.
(© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)