Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

NCT03496441 | Completed

• 1 other identifier: CE 17.243
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Inflammatory Bowel Diseases; Microbiota; Anastomotic Leak

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.

  6 months

Study Arms (4)

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).

Other: Fecal sample collection for analysis

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.

Other: Fecal sample collection for analysis

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).

Other: Fecal sample collection for analysis

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).

Other: Fecal sample collection for analysis

Interventions

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.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier Universitaire de Montreal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammatory Bowel Diseases; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carole Richard, MD, FRCSC

  Centre Hospitalier Universitaire de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: April 12, 2018
• Study Start: January 30, 2018
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 12, 2018

Record last verified: 2018-03

Locations

CA (1)