NCT01786694已完成3 期
Feasibility of Microdialysis by Laparoscopy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- functional success of microdialysis
研究概览
简要总结
The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •rectal disease requiring proctectomy with anastomosis and stomy
- •proctectomy by laparoscopy
- •written consent
排除标准
- •history of colorectal surgery
- •rectal surgery without anastomosis
- •breastfeeding or pregnancy
- •ASA score IV
结局指标
主要结局
functional success of microdialysis
时间窗: postoperative day 5
the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter
次要结局
- anastomotic leaks rate(postoperative day 30)
- the mortality rate(postoperative day 30)
- superficial surgical site infection rate(postoperative day 30)
- the quality of life after the surgery(postoperative day 30)
研究者
研究点 (1)
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