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NCT04071964 Clinical Trial

Gut Microbiota, Anastomotic Leak and Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:
Gut Microbiota, Anastomotic Leak and Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04071964
Other study ID # 19.021-YP,2020-8305
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 9, 2019
Est. completion date July 9, 2025

Study information
Verified date May 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

No more details required

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date July 9, 2025
Est. primary completion date July 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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")

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Centre hospitalier de l'Université de Montréal Montréal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with an anastomotic leak Clinical and/or radiological anastomotic leak 1 month
Secondary Number of participants with cancer reoccurence Colorectal cancer local or distant reoccurence 3 years
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