ClinicalTrials.gg
CompletedNCT03496441Updated Apr 12, 2018

Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

An observational study in Colorectal Cancer, Inflammatory Bowel Diseases and Microbiota, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Colorectal Neoplasms by Centre hospitalier de l'Université de Montréal (CHUM) — 5 open to participants now, 6 under way, none of them phase 3. Colorectal Neoplasms · Centre hospitalier de l'Université de Montréal (CHUM).

Started
2018
with 1 other
Observational
4 of 12
1 open now
Registered
1st of 12
by date

Among the 12 studies in Colorectal Neoplasms by Centre hospitalier de l'Université de Montréal (CHUM), this one is one of 2 that started in 2018, is one of 4 observational ones, and was the 1st registered.

Colorectal Neoplasms

6,544 studies on the registry are indexed under Colorectal Neoplasms; 1,666 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

5 of the 12 studies in Colorectal Neoplasms by Centre hospitalier de l'Université de Montréal (CHUM) are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 1,184 Colorectal Neoplasms studies recruiting now, 767 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 124 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

No more details required.

03

Conditions studied

  • Colorectal Cancer
  • Inflammatory Bowel Diseases
  • Microbiota
  • Anastomotic Leak
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

ALL

  • 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

Exclusion Criteria:

  • Pregnancy.
  • Class of the (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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and 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).

    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

  • OtherFecal 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 months

  2. Evaluate the feasibility of fecal samples' analysis

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

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Montreal (CHUM)
    Montréal, Quebec H2X 3E4, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Apr 2018, 2 months.

Of 529 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's 2 months is below that.

Counting every sponsor, half of 646 studies reached it within 52 months; a quarter within 27 and three quarters within 104.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2018
First posted
Apr 12, 2018
StartActual
Jan 30, 2018
Primary completionActual
Apr 1, 2018
CompletionActual
Apr 1, 2018
Last update
Apr 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03496441
Responsible party
Sponsor
First posted
Apr 12, 2018
Start date
Jan 30, 2018
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
Apr 12, 2018

Study contacts

Carole Richard, MD, FRCSC
principal investigator · Centre Hospitalier Universitaire de Montreal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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