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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.

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/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.

SUBMITTER: Robert M

PROVIDER: S-EPMC7467507 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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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.

Robert Maud M Poghosyan Tigran T Delaunay Dominique D Pelascini Elise E Iceta Sylvain S Sterkers Adrien A Barsamian Charles C Khamphommala Litavan L Bin Dorel Sylvie S Maucort-Boulch Delphine D Czernichow Sebastien S Disse Emmanuel E

BMJ open 20200901 9

<h4>Introduction</h4>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 c ...[more]

PMID: 32873678

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Project description:BackgroundBariatric surgery is more effective in the management of morbid obesity and related comorbidities than is conservative therapy. Pylorus-preserving single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-SG) is a modified duodenal switch technique. Gastric plication (GP) is an alternate to SG.MethodsMorbidly obese (BMI of > 40, or > 35 in the presence of diabetes or prediabetes) patients were recruited and operated on to perform SADI with GP. Complications related to surgery were recorded to assess the feasibility of the procedure. Weight-loss outcomes were analysed to determine efficacy. Minnesota Multiphasic Personality Inventory 2 (MMPI-2) was recorded after 1 year of follow-up, and test scales were used to describe physiological phenomena.ResultsSeventeen middle-aged (mean: 40 years) patients were involved in our study; 15 of them were females. The mean duration of surgery was 205 min. There were no complications of conversion, death, bleeding, VTE or 30-day readmission to hospital. We did experience CD4a (pulmonary insufficiency due to chronic lung disease) and a CD3b (anastomosis leakage treated laparoscopically) complications. Vomiting occurred in three cases (CD1). Obesity-related comorbidities showed favourable resolution rates (77.8% for hypertension, 81.2% for dyslipidaemia, 100% for diabetes at the 1-year follow-up). Weight-loss outcomes were favourable (53.20 EWL%, and 35.58 TWL% at 1-year follow-up). Greater weight loss caused significantly higher levels of Depression (t(13.958) = - 2.373; p = 0.00; p < 0.05) and Low Positive Emotions (t(13.301) = - 2.954; p = 0.00; p < 0.05) and Introversion/Low Positive Emotionality (t(13.408) = - 1.914; p = 0.02; p < 0.05) in MMPI-2 data.ConclusionAccording to our safety study, SADI-GP is a promising malabsorptive procedure, but a long-term high-volume case series or a randomised controlled trial is necessary to evaluate complication rates and weight-loss outcomes. Emotional dysregulation is common among bariatric surgery patients according to personality inventory data; therefore, psychological follow-up and psychotherapeutic support are necessary for weight-loss maintenance.

Dataset Information

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.

Publications

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.

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