NCT00636948已完成不适用
Rectal Cancer Trial On Defunctioning Stoma
Rectal Cancer Trial on Defunctioning Stoma Study Group1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 1999年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma.
研究概览
简要总结
The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.
详细描述
The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Absence of intraoperative adverse events according to the study protocol and the operating surgeon.
排除标准
- •Presence of intraoperative adverse events according to the study protocol and the operating surgeon.
结局指标
主要结局
Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma.
时间窗: 30 days, one year and five years.
次要结局
- Reoperation within 30 days of initial surgery.(30 days)
研究者
研究点 (1)
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