NCT01774682已完成3 期
Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
6-minute walk test
Other
the 6-minute walk test is performed for each patient prior to the surgery and 6 months after by a specialist.
干预措施: 6-minute walk test (Procedure)
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
研究点 (1)
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