Gut Microbiota, Anastomotic Leak and Colorectal Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer

Detailed Description

No more details required

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with an anastomotic leak	Clinical and/or radiological anastomotic leak	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with cancer reoccurence	Colorectal cancer local or distant reoccurence	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Anticipated): January 9, 2024
• Study Completion (Anticipated): January 9, 2024

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Microbiota
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Anastomotic Leak
• Other Study ID Numbers: 19.021-YP,2020-8305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No