Gut Microbiota, Anastomotic Leak and Colorectal Cancer
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2019
CompletedFirst Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2025
CompletedMay 16, 2024
May 1, 2024
6 years
August 26, 2019
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with an anastomotic leak
Clinical and/or radiological anastomotic leak
1 month
Secondary Outcomes (1)
Number of participants with cancer reoccurence
3 years
Study Arms (4)
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
Eligibility Criteria
Patients with colorectal cancer undergoing surgical resection (or expectative management for rectal cancer after complete clinical response to chemoradiotherapy)
You may qualify if:
- 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)
You may not qualify if:
- Pregnancy
- Previous stoma
- Bowel surgery in the last 4 weeks prior to the surgery
- Age 18 years and older
- Rectal cancer diagnosis with histopathological confirmation
- Abdominoperineal resection with terminal colostomy
- Expectative non-surgical management ("Watch and wait approach")
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
August 28, 2019
Study Start
July 9, 2019
Primary Completion
July 9, 2025
Study Completion
July 9, 2025
Last Updated
May 16, 2024
Record last verified: 2024-05