The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anastomotic leakage
研究概览
简要总结
Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.
详细描述
Patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.
Patients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. Patients who were suspected to have AL underwent CT with rectal contrast to assess the integrity of the anastomosis. The primary outcome was the incidence of AL. We adopted the definition published by the International Study Group of Rectal Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer
排除标准
- •No anastomosis
研究组 & 干预措施
TD
干预措施: Tube drain insertion (Other)
NTD
结局指标
主要结局
Anastomotic leakage
时间窗: 30 days
Prevention
次要结局
未报告次要终点
研究者
Pierpaolo Sileri
Professor
University of Rome Tor Vergata
