Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496441
• Other study ID #: CE 17.243
• Status: Completed
• First received: February 14, 2018
• Last updated: April 5, 2018
• Start date: January 30, 2018
• Est. completion date: April 1, 2018

Study information

• Verified date: March 2018
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

No more details required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anastomotic Leak
• Colorectal Cancer
• Colorectal Neoplasms
• Inflammatory Bowel Diseases
• Microbiota

Intervention

Other:
• Fecal sample collection for analysis
Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering MiSeq reads into operational taxonomic units (OTUs); Iron and heme measurements in the samples.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Montreal (CHUM)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the feasibility of patients' recruitment	Evaluate if we can recruit all required patients easily ; 20 patients total and 5 patients per group (Yes or No).	3 months
Primary	Evaluate the feasibility of fecal samples' analysis	Evaluate if we can easily perform the fecal sample analysis with the establish procedures (Yes or No).	3 months
Secondary	Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.	If it is possible to obtain results from the fecal samples' analysis, a possible correlation in the results will be evaluate.	6 months