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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.
No more details required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Colorectal cancer patients who will undergo a surgical resection with digestive anastomosis. Fecal sample collection for analysis before and after surgery (2 samples). |
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| Group 2 | 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. |
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| Group 3 | 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). |
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| Group 4 | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal sample collection for analysis | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
ALL
Informed consent obtained.
Between 18 to 90 years old inclusive.
Group 1 (colorectal cancer patients)
Group 2 (anastomotic leak patients)
Group 3 ("healthy" patients)
Group 4 (inflammatory bowel disease patients)
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Carole Richard, MD, FRCSC | Centre Hospitalier Universitaire de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Montreal (CHUM) | Montreal | Quebec | H2X 3E4 | Canada |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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For participants included in groups 1, 3 and 4, stool samples will be collected prior to surgery. For participants included in group 1 only, a stool sample will also be collected after surgery.
For patients included in group 2, a sample of the digestive content (stool) will be collected during surgery.
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005759 | Gastroenteritis |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |