Clinical trial NCT03496441: Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study
Official title: The Relationship Between Intestinal Microbiota, Colorectal Cancer and Anastomotic Leakage After Colorectal Surgery: Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Inflammatory Bowel Diseases
Microbiota
Anastomotic Leak
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants included in groups 1,3 and 4 will be recruited at the outpatient clinic of the CHUM digestive surgery department, during the visit for evaluation prior surgery.

Participants included in group 2 will be recruited during the post surgery period, during their hospitalization in the department of digestive surgery of the CHUM.

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.

Eligibility criteria: Inclusion Criteria:

ALL

* 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.
  * Patients with no history of colorectal neoplasia or surgical resection of the gastrointestinal tract.
* Group 4 (inflammatory bowel disease patients)

  * Patients with inflammatory bowel disease (IBD), waiting for elective surgery involving gastrointestinal resection.

Exclusion Criteria:

* Pregnancy.
* Class of the American Society of Anesthesiologists (ASA)\> 3.
* 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).

Primary outcomes:
measure: Evaluate the feasibility of patients' recruitment
timeFrame: 3 months
measure: Evaluate the feasibility of fecal samples' analysis
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.
timeFrame: 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montreal (CHUM)
state: Quebec
Study officials:
affiliation: Centre Hospitalier Universitaire de Montreal
name: Carole Richard, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: