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Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03496441
Enrollment
20
Registered
2018-04-12
Start date
2018-01-30
Completion date
2018-04-01
Last updated
2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Colorectal Cancer, Inflammatory Bowel Diseases, Microbiota

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.

Interventions

OTHERFecal 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.

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the feasibility of patients' recruitment3 monthsEvaluate 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' analysis3 monthsEvaluate if we can easily perform the fecal sample analysis with the establish procedures (Yes or No).

Secondary

MeasureTime frameDescription
Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.6 monthsIf it is possible to obtain results from the fecal samples' analysis, a possible correlation in the results will be evaluate.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026