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Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

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ClinicalTrials.gov Identifier: NCT03496441
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.


Condition or disease Intervention/treatment
Colorectal Cancer Inflammatory Bowel Diseases Microbiota Anastomotic Leak Other: Fecal sample collection for analysis

Detailed Description:
No more details required.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Relationship Between Intestinal Microbiota, Colorectal Cancer and Anastomotic Leakage After Colorectal Surgery: Pilot Study
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.


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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496441


Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Montreal (CHUM)
Montréal, Quebec, Canada, H2X 3E4
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Carole Richard, MD, FRCSC Centre Hospitalier Universitaire de Montreal

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03496441     History of Changes
Other Study ID Numbers: CE 17.243
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Inflammatory Bowel Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Anastomotic Leak
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Gastroenteritis
Postoperative Complications
Pathologic Processes