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临床试验/NCT01774682
NCT01774682已完成3 期

Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
99
试验地点
2
主要终点
6-minute walk test

研究概览

简要总结

The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.

详细描述

Laparoscopic Sleeve gastrectomy is the standard surgical procedure for the treatment of obese patients. Even the surgery is well described, there is no available study about its influence on the functional parameters of patients perambulation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • BMI between 40 and 60 kg/m2 or BMI > 35 kg/m2 with at least one comorbidity
  • no weight loss
  • between 18 and 65 years old
  • history of obesity > 5 ans

排除标准

  • history of bariatric surgery
  • major cardiac insufficiency
  • pregnancy or breastfeeding
  • no social welfare

结局指标

主要结局

6-minute walk test

时间窗: 6 months after the surgery

the value of this test is obtained by the difference between the 6-minute walk test performed before the surgery and the 6-minute walk test performed 6 months after the surgery

次要结局

  • quality of life(6 months after the surgery)
  • BAROS score(6 months after the surgery)
  • quality of life with the Mooreheald-Ardelt questionnaire(6 months after the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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