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Clinical Trials/NCT04071964
NCT04071964
Active, not recruiting
Not Applicable

Gut Microbiota, Anastomotic Leak and Colorectal Cancer

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country300 target enrollmentJuly 9, 2019
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ConditionsColorectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
300
Locations
1
Primary Endpoint
Number of participants with an anastomotic leak
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Detailed Description

No more details required

Registry
clinicaltrials.gov
Start Date
July 9, 2019
End Date
July 9, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

Eligibility Criteria

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")

Outcomes

Primary Outcomes

Number of participants with an anastomotic leak

Time Frame: 1 month

Clinical and/or radiological anastomotic leak

Secondary Outcomes

  • Number of participants with cancer reoccurence(3 years)

Study Sites (1)

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