NCT03496441

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
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-30
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2018-04-12
• Last updated: 2018-04-12

Locations

1 site across 1 country: Canada