比较单吻合十二指肠-回肠旁路术与袖状胃切除术（SADI-S）及Roux-en-Y胃旁路术（RYGB）疗效和安全性的前瞻性多中心随机试验：SADISLEEVE研究方案
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.
作者信息
Robert Maud, Poghosyan Tigran, Delaunay Dominique, Pelascini Elise, Iceta Sylvain, Sterkers Adrien, Barsamian Charles, Khamphommala Litavan, Bin Dorel Sylvie, Maucort-Boulch Delphine, Czernichow Sebastien, Disse Emmanuel
机构信息
Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, CarMeN Laboratory, INSERM 1060, Université Claude Bernard Lyon 1, Lyon, France.
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
出版信息
BMJ Open. 2020 Sep 1;10(9):e037576. doi: 10.1136/bmjopen-2020-037576.
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/m or ≥35 kg/m 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 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.
引言
尽管Roux-en-Y胃旁路术（RYGB）在中期的减重失败率不可忽视，但它仍是治疗伴有代谢合并症的病态肥胖症的参考术式。一种最近出现的术式，即单吻合口十二指肠-回肠旁路术联合袖状胃切除术（SADI-S），在减重方面可能比RYGB更有效，且发病率相似，减重失败率更低。我们提出了第一项将SADI-S与RYGB进行比较的随机、开放、多中心优效性试验（SADISLEEVE）。
方法与分析
主要目的是证明在术后2年时，SADI-S在超重减轻百分比方面优于RYGB。次要目的是评估术后2年内的营养状况、代谢结果、总体并发症发生率和生活质量。关键纳入标准为体重指数（BMI）≥40 kg/m²或≥35 kg/m²且至少有一种合并症的肥胖患者，以及初次接受减重手术或袖状胃切除术后失败的患者。基于中心、作为修正手术的手术方式、2型糖尿病的存在以及BMI>50 kg/m²，通过最小化法将患者随机分为两组，为期2年。每组166例患者的样本量将有90%的把握度，在双侧显著性水平为5%的情况下，检测出RYGB组的超重减轻小于SADI-S组的超重减轻的概率为0.603。若失访率为10%，则每组需要纳入183例患者。
伦理与传播
该研究已获得莫尔旺大学中心医院机构审查委员会（CPP1089-HPS1）的批准。该研究也获得了法国国家药品安全局的批准（2018061500148）。结果将在同行评审的科学期刊上发表。
试验注册号
NCT03610256。
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