Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer
详细描述
The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.
Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.
Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.
A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.
If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18 years or older.
- •All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
- •Written informed consent was obtained from all patients
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: Death occurring during the first 90 days
Death occurring during the first 90 postoperative days
次要结局
未报告次要终点
研究者
Mark Ellebaek Pedersen
Doctor
Odense University Hospital