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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)

Tracking Information
First Submitted Date February 14, 2018
First Posted Date April 12, 2018
Last Update Posted Date April 12, 2018
Actual Study Start Date January 30, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2018)
  • 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).
  • 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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 5, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study
Official Title The Relationship Between Intestinal Microbiota, Colorectal Cancer and Anastomotic Leakage After Colorectal Surgery: Pilot Study
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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.

Condition
  • Colorectal Cancer
  • Inflammatory Bowel Diseases
  • Microbiota
  • Anastomotic Leak
Intervention 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.
Study Groups/Cohorts
  • 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).
    Intervention: 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.
    Intervention: 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).
    Intervention: 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).
    Intervention: Other: Fecal sample collection for analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2018)
20
Original Actual Enrollment Same as current
Actual Study Completion Date April 1, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03496441
Other Study ID Numbers CE 17.243
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators Not Provided
Investigators
Principal Investigator: Carole Richard, MD, FRCSC Centre Hospitalier Universitaire de Montreal
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date March 2018