Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass. Monocentric, Comparative, Randomized, Open Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms
研究概览
简要总结
Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 65 years old.
- •Have had a gastric bypass in Y more than 2 years ago
- •Have a weight regain of more than 10% of the lowest weight after the first intervention.
- •Have benefited from a multidisciplinary medico-psychological reassessment.
- •Understand the interest of the study and agree to long-term follow-up.
- •Agree to be included in the study and have signed a consent form in a free and informed manner.
- •Be affiliated with health insurance.
- •For female patients of childbearing potential, have an effective method of contraception
排除标准
- •Presence of a disease unrelated to obesity that is life-threatening.
- •Pregnancy or wish to become pregnant within the year.
- •"Breastfeeding" patients
- •Female patients of childbearing age and unable or unwilling to use an effective method of contraception
- •Presence of an unhealed gastric ulcer or stenosis of the gastrointestinal anastomosis
- •Presence of a psychiatric pathology compromising the proper understanding of the study or patient under guardianship or guardianship.
- •Patient not understanding French or unable to give consent.
- •Patient already included in a study or in conflict of interest with this study.
结局指标
主要结局
Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms
时间窗: Day 0 (before the intervention) and Months 12 (one year after Day 0)
The percentage of excess weight loss (PEP%) will be measured according to the formula: PEP% = weight loss in kg \* 100 / excess of initial weight. The initial excess weight is defined as the baseline weight - ideal weight.
次要结局
未报告次要终点