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临床试验/NCT03097926
NCT03097926已完成不适用

Prospective Randomized Trial of Duodenal Switch With a Standard Versus Long Alimentary Limb.

Laval University0 个研究点目标入组 20 人开始时间: 2013年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurent Biertho

Clinical Professor

Laval University

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