Gut Microbiota, Anastomotic Leak and Colorectal Cancer

NCT ID: NCT04071964

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-09

Study Completion Date

2025-07-09

Brief Summary

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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

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No more details required

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Groupe 1

Patients with colorectal cancer undergoing resection with anastomosis

No interventions assigned to this group

Groupe 2

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

No interventions assigned to this group

Groupe 3

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

No interventions assigned to this group

Groupe 4

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

No interventions assigned to this group

Eligibility Criteria

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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)


* Age 18 years and older
* Rectal cancer diagnosis with histopathological confirmation
* Abdominoperineal resection with terminal colostomy
* Expectative non-surgical management ("Watch and wait approach")

Exclusion Criteria

* Pregnancy
* Previous stoma
* Bowel surgery in the last 4 weeks prior to the surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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19.021-YP,2020-8305

Identifier Type: -

Identifier Source: org_study_id

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