NCT00828035已完成2 期
Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of useful hands, robot as a useful mechanical hand
研究概览
简要总结
Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment)
Primary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand)
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laparoscopic surgery indicated
- •Subject with ASA Score 1, 2 or 3
- •Subject with health and social protection
- •18 years of age or older
- •Written Informed Consent
排除标准
- •Subject is pregnant or lactating
- •Subject in jail
- •Subject hospitalizes without consent
- •Protected persons aged 18 years or older
- •Subject participated in another study
结局指标
主要结局
Number of useful hands, robot as a useful mechanical hand
时间窗: one month
次要结局
- To evaluate reliability and limits of light endoscopic robot : Number of breakdown, failure (manipulation, voice recognition, other )(one month)
- Compare surgeon's visual comfort in two groups (REL group and AO group) : evaluate scale of surgeon's visual comfort during surgery(one month)
- Compare surgery's periods(one month)
- Evaluate complications : Number of complications (per operative, post operative)(one month)
- Evaluate medical and paramedical use of light endoscopic robot : apprentice time, labour time(one month)
- Medical and economic evaluation : cost benefit analysis : human cost, cost(one month)
研究者
AdministrateurCIC
principal investigator
University Hospital, Grenoble
研究点 (2)
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