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临床试验/NCT04071964
NCT04071964进行中(未招募)不适用

Gut Microbiota, Anastomotic Leak and Colorectal Cancer

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
1
主要终点
Number of participants with an anastomotic leak

研究概览

简要总结

This is a prospective study evaluating the relation between the gut microbiota composition, intestinal healing after colorectal surgery and colorectal cancer behavior.

Our hypothesis is that the gut microbiota composition could predict poor intestinal healing in colorectal surgery, and that the gut microbiota might have an impact on colorectal cancer clinical behavior and may predict disease outcomes.

详细描述

No more details required

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Age 18 years and older
  • CRC diagnosis
  • Upcoming colonic and/or rectal resection with/without anastomosis
  • Individuals without diseases of the colon and rectum (healthy controls)

排除标准

  • Pregnancy
  • Previous stoma
  • Bowel surgery in the last 4 weeks prior to the surgery
  • Secondary objectives, inclusion criteria are as follows:
  • Age 18 years and older
  • Rectal cancer diagnosis with histopathological confirmation
  • Abdominoperineal resection with terminal colostomy
  • Expectative non-surgical management ("Watch and wait approach")

结局指标

主要结局

Number of participants with an anastomotic leak

时间窗: 1 month

Clinical and/or radiological anastomotic leak

次要结局

  • Number of participants with cancer reoccurence(3 years)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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