Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

Study Overview
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Brief Summary
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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
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No more details required.

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

Conditions
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Colorectal Cancer, Inflammatory Bowel Diseases, Microbiota, Anastomotic Leak

Intervention / Treatment
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* Other: Fecal sample collection for analysis


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Colorectal cancer patients who will undergo a surgical resection with digestive anastomosis. Fecal sample collection for analysis before and after surgery (2 samples). | Other: Fecal sample collection for analysis<br>* 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.<br>|
| Group 2<br>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. | Other: Fecal sample collection for analysis<br>* 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.<br>|
| Group 3<br>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). | Other: Fecal sample collection for analysis<br>* 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.<br>|
| Group 4<br>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). | Other: Fecal sample collection for analysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |