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Completed

NCT Number: NCT03496441

Microbiota-anastomotic Leak Among Colorectal Surgery Patients : 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.

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Key information

Conditions

Colorectal Cancer Anastomotic Leak Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Microbiota Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Montreal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

About this study

No more details required.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Evaluate the feasibility of patients' recruitment

    Time frame: 3 months

    Evaluate if we can recruit all required patients easily ; 20 patients total and 5 patients per group (Yes or No).

  2. Evaluate the feasibility of fecal samples' analysis

    Time frame: 3 months

    Evaluate if we can easily perform the fecal sample analysis with the establish procedures (Yes or No).

Secondary outcomes

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

    Time frame: 6 months

    If it is possible to obtain results from the fecal samples' analysis, a possible correlation in the results will be evaluate.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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