Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

NCT ID: NCT03496441

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2018-04-01

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.

Conditions

Colorectal Cancer; Inflammatory Bowel Diseases; Microbiota; Anastomotic Leak

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Fecal sample collection for analysis

Intervention Type: 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.

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.

Fecal sample collection for analysis

Intervention Type: 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.

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).

Fecal sample collection for analysis

Intervention Type: 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.

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).

Fecal sample collection for analysis

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carole Richard, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Montreal

Locations

Centre Hospitalier Universitaire de Montreal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CE 17.243

Identifier Type: -

Identifier Source: org_study_id