Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

Completed

• Conditions: Colorectal Cancer; Inflammatory Bowel Diseases; Microbiota; Anastomotic Leak
• Interventions: Other: Fecal sample collection for analysis

• Registration Number: NCT03496441
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (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.

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2018-02-14
• Status Verified: 2018-03
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Study First Submitted QC: 2018-04-05
• Last Update Submitted: 2018-04-05
• Study First Posted: 2018-04-12
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 4	Fecal sample collection for analysis	Inflammatory bowel disease patients waiting for elective surgery involving gastrointestinal resection. Fecal sample collection for analysis during surgery, directly from the bowel content (1 sample).
Group 1	Fecal sample collection for analysis	Colorectal cancer patients who will undergo a surgical resection with digestive anastomosis. Fecal sample collection for analysis before and after surgery (2 samples).
Group 2	Fecal sample collection for analysis	Patients having undergone surgical resection with digestive anastomosis for colorectal cancer or inflammatory bowel disease, complicated by anastomotic leakage. Fecal sample collection for analysis after surgery, once the leak is confirmed.
Group 3	Fecal sample collection for analysis	Patients with uncomplicated hernia pathology, without gastrointestinal comorbidity to undergo a surgery to heal this hernia without involving a gastrointestinal resection. Fecal sample collection for analysis before surgery (1 sample).

Primary Outcome Measures

Name	Time	Method
Evaluate the feasibility of patients' recruitment	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	3 months	Evaluate if we can easily perform the fecal sample analysis with the establish procedures (Yes or No).

Secondary Outcome Measures

Name	Time	Method
Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.	6 months	If it is possible to obtain results from the fecal samples' analysis, a possible correlation in the results will be evaluate.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Montreal (CHUM); 🇨🇦 Montréal, Quebec, Canada