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Gut Microbiota, Anastomotic Leak and Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04071964
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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Brief Summary:

This is a prospective correlational 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
Colorectal Cancer

Detailed Description:
No more details required

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Number of participants with an anastomotic leak [ Time Frame: 1 month ]
    Clinical and/or radiological anastomotic leak


Secondary Outcome Measures :
  1. Number of participants with cancer reoccurence [ Time Frame: 3 years ]
    Colorectal cancer local or distant reoccurence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colorectal cancer undergoing surgical resection (or expectative management for rectal cancer after complete clinical response to chemoradiotherapy)
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • CRC diagnosis
  • Upcoming colonic and/or rectal resection with/without anastomosis

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071964


Contacts
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Contact: Carole Richard, MD, FRCSC 514-890-8000 ext 34007 carole.richard.chum@ssss.gouv.qc.ca
Contact: Sabrina Lavoie 514-890-8000 ext 10812 sabrina.lavoie.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 3E4
Principal Investigator: Carole Richard, MD, FRCSC         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
More Information
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04071964     History of Changes
Other Study ID Numbers: 19.021-YP,2020-8305
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: July 2019

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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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
 Anastomotic Leak
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes