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
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 gastrect...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e037576.full |
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| author | Delphine Maucort-Boulch Maud Robert Tigran Poghosyan Dominique Delaunay Elise Pelascini Sylvain Iceta Adrien Sterkers Charles Barsamian Litavan Khamphommala Sylvie Bin Dorel Sebastien Czernichow Emmanuel Disse |
| author_facet | Delphine Maucort-Boulch Maud Robert Tigran Poghosyan Dominique Delaunay Elise Pelascini Sylvain Iceta Adrien Sterkers Charles Barsamian Litavan Khamphommala Sylvie Bin Dorel Sebastien Czernichow Emmanuel Disse |
| author_sort | Delphine Maucort-Boulch |
| collection | DOAJ |
| description | 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/m2 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/m2 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. |
| format | Article |
| id | doaj-art-92f9fc013cd5464a8fd83289d1ec6c40 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-92f9fc013cd5464a8fd83289d1ec6c402025-01-09T00:10:10ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037576Prospective 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 protocolDelphine Maucort-Boulch0Maud Robert1Tigran Poghosyan2Dominique Delaunay3Elise Pelascini4Sylvain Iceta5Adrien Sterkers6Charles Barsamian7Litavan Khamphommala8Sylvie Bin Dorel9Sebastien Czernichow10Emmanuel Disse11University Claude Bernard Lyon 1, Villeurbanne, FranceDepartment of Digestive and Bariatric Surgery, Hôpital Edouard Herriot, Lyon, FranceDepartment 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, FranceDepartment of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, FranceDepartment of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, FranceDepartment of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, FranceDepartment of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, FranceDepartment of Nutrition, Specialized Center for Obesity Management, Assistance Publique – Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, FranceDepartment of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, FranceClinical Research Unit, Hospices Civils de Lyon, Lyon, FranceDepartment of Nutrition, Specialized Center for Obesity Management, Assistance Publique – Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, FranceDepartment of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, FranceIntroduction 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/m2 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/m2 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.https://bmjopen.bmj.com/content/10/9/e037576.full |
| spellingShingle | Delphine Maucort-Boulch Maud Robert Tigran Poghosyan Dominique Delaunay Elise Pelascini Sylvain Iceta Adrien Sterkers Charles Barsamian Litavan Khamphommala Sylvie Bin Dorel Sebastien Czernichow Emmanuel Disse 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/9/e037576.full |
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