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Gut Microbiota, Anastomotic Leak and Colorectal Cancer

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Recruiting
CT.gov ID
NCT04071964
Collaborator
(none)
300
Enrollment
1
Location
36
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    No more details required

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Gut Microbiota, Anastomotic Leak and Colorectal Cancer
    Actual Study Start Date :
    Jul 9, 2019
    Anticipated Primary Completion Date :
    Jul 9, 2022
    Anticipated Study Completion Date :
    Jul 9, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Groupe 1

    Patients with colorectal cancer undergoing resection with anastomosis
    Groupe 2

    Patients with colorectal cancer undergoing resection without anastomosis (Abdominoperineal resection)
    Groupe 3

    Patients with rectal cancer without surgery ("Watch and wait")
    Groupe 4

    Control group consisting of patients who do not have surgical pathologies of the colon and rectum

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with an anastomotic leak [1 month]

      Clinical and/or radiological anastomotic leak

    Secondary Outcome Measures

    1. Number of participants with cancer reoccurence [3 years]

      Colorectal cancer local or distant reoccurence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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")

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre hospitalier de l'Université de Montréal Montréal Quebec Canada H2X 3E4

    Sponsors and Collaborators

    • Centre hospitalier de l'Université de Montréal (CHUM)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre hospitalier de l'Université de Montréal (CHUM)
    ClinicalTrials.gov Identifier:
    NCT04071964
    Other Study ID Numbers:
    • 19.021-YP,2020-8305
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Aug 25, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM)
    Microbiota
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Anastomotic Leak

    Study Results

    No Results Posted as of Aug 25, 2021