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临床试验/NCT03325361
NCT03325361Unknown不适用

The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage

University of Rome Tor Vergata2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Tube drain insertion (Other)

NTD

No Intervention

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

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierpaolo Sileri

Professor

University of Rome Tor Vergata

研究点 (2)

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