NCT01999634已完成3 期
Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- anastomotic leaks rate
研究概览
简要总结
The aim of this study is to monitor by microdialysis the postoperative outcomes 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
- Diagnostic
- 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 or laparotomy
- •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
anastomotic leaks rate
时间窗: postoperative day 30
the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan or at the clinical examination
次要结局
- functional success of microdialysis(postoperative day 5)
- superficial surgical site infection rate(postoperative day 30)
研究者
研究点 (2)
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