Skip to main content
Clinical Trials/NCT03496441
NCT03496441
Completed
Not Applicable

The Relationship Between Intestinal Microbiota, Colorectal Cancer and Anastomotic Leakage After Colorectal Surgery: Pilot Study

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country20 target enrollmentJanuary 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
20
Locations
1
Primary Endpoint
Evaluate the feasibility of patients' recruitment
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. This different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates.

The objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection.

Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease.

The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make up the microbiota of each patient.

Detailed Description

No more details required.

Registry
clinicaltrials.gov
Start Date
January 30, 2018
End Date
April 1, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Informed consent obtained.
  • Between 18 to 90 years old inclusive.
  • Group 1 (colorectal cancer patients)
  • Patients with colorectal cancer confirmed with pathology results.
  • Oncological colon and / or rectal resection planned and performed by a surgeon from the digestive surgery department of the CHUM.
  • Group 2 (anastomotic leak patients)
  • Patients with colorectal cancer confirmed with pathology and / or patients with inflammatory bowel disease.
  • Patients who underwent colonic and / or rectal surgical resection, complicated by an anastomotic leak in the postoperative period.
  • Group 3 ("healthy" patients)
  • Patients with uncomplicated hernia pathology assessed externally in anticipation or after hernia repair surgery that does not involve gastrointestinal resection.

Exclusion Criteria

  • Pregnancy.
  • Class of the American Society of Anesthesiologists (ASA)\>
  • Chemotherapy and / or pelvic and / or abdominal radiotherapy within 6 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).
  • Colonoscopy within 3 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).

Outcomes

Primary Outcomes

Evaluate the feasibility of patients' recruitment

Time Frame: 3 months

Evaluate if we can recruit all required patients easily ; 20 patients total and 5 patients per group (Yes or No).

Evaluate the feasibility of fecal samples' analysis

Time Frame: 3 months

Evaluate if we can easily perform the fecal sample analysis with the establish procedures (Yes or No).

Secondary Outcomes

  • Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.(6 months)

Study Sites (1)

Loading locations...

Similar Trials