Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Total weight change
研究概览
简要总结
The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein deficiency, vitamin and trace element deficit compared to standard BPD-DS.
详细描述
This two-group, randomized, single-blind pilot study is conducted in a university-affiliated tertiary care center. The study protocol was approved by our ethic committee. Enrollment and randomization of the patients occurred between May 20163 and June 2015. Patients are undergoing follow-up evaluation. Patients were initially referred to our center for a bariatric surgery evaluation. Eligible patients were 18 years of age or older and met the criteria for a laparoscopic biliopancreatic diversion. Patients were excluded if they had a BMI ≥ 50 mg/m², a pacemaker, cirrhosis or if they were planing pregnancy in the next 2 years. Each patient was required to provide written informed consent. Patients were randomly assigned in a 1:1 ratio to undergo a standard biliopancreatic diversion (control group) or a modified biliopancreatic diversion with a longer strict alimentary limb (study group). A sealed envelope with the assignation was given to the surgeon in the operation room just before the procedure. Patients are followed every 6 months after surgery, up to 24-months for clinical evaluation, resolution of comorbidities, evaluation of side-effects, quality of life, bioimpedance testing and bloodwork.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for a biliopancreatic diversion, BMI above 35 with comorbidities or above 40 without comorbidities
排除标准
- •BMI ≥ 50 mg/m², pacemaker, cirrhosis or planning pregnancy in the next 2 years, hypoalbuminemia, irritable bowel syndrome.
结局指标
主要结局
Total weight change
时间窗: 6, 12, 18, 24 months
Changes in total body weight, in kg, from baseline
次要结局
- Changes in Quality of life(6, 12, 18, 24 months)
- Changes in Gastro-intestinal side-effects scores(6,12,18,24 months)
研究者
Laurent Biertho
Clinical Professor
Laval University
