Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Colorectal Cancer; Anastomotic Leak; Microbiota
• Intervention / Treatment: Other: Fecal sample collection for analysis

Detailed Description

No more details required.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Centre Hospitalier Universitaire de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.
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; 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Carole Richard, MD, FRCSC, Centre hospitalier universitaire de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Anastomotic Leak
• Other Study ID Numbers: CE 17.243

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No