Colorectal CancerNCT03496441
Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study
An observational study of Colorectal Cancer and Inflammatory Bowel Diseases, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Inflammatory Bowel Diseases, Microbiota
- What is being tested?
- Fecal sample collection for analysis
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2018to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Montreal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: 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.
Read more
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.
- Being tested
- Fecal sample collection for analysis
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal sample collection for analysisOther
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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). Receives: 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). Receives: Other: Fecal sample collection for analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start30 Jan 2018
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole Richard, MD, FRCSC, Principal investigator, Centre Hospitalier Universitaire de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496441
- Sponsor's protocol ID
- CE 17.243
- Status last verified
- Mar 2018
- First submitted
- 14 Feb 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Intestinal Microbiota, Colorectal Cancer and Anastomotic Leakage After Colorectal Surgery: Pilot Study
- ClinicalTrials.gov ID
- NCT03496441
- Acronym / sponsor ID
- CE 17.243
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Fecal sample collection for analysisColorectal cancer patients who will undergo a surgical resection with digestive anastomosis. Fecal sample collection for analysis before and after surgery (2 samples). |
| Group 2 | – | Other: Fecal sample collection for analysisPatients 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. |
| Group 3 | – | Other: Fecal sample collection for analysisPatients 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). |
| Group 4 | – | Other: Fecal sample collection for analysisInflammatory bowel disease patients waiting for elective surgery involving gastrointestinal resection. Fecal sample collection for analysis during surgery, directly from the bowel content (1 sample). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- ALL
- Informed consent obtained.
- Between 18 to 90 years old inclusive.
- Group 1 (colorectal cancer patients)
- Group 2 (anastomotic leak patients)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal sample collection for analysisFecal 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. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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).
1 secondary outcome
Evaluation the presence of a correlation between fecal microbiota composition and the risk of anastomotic leak.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Richard, MD, FRCSC principal investigator
Centre Hospitalier Universitaire de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Inflammatory Bowel Diseases, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of patients' recruitment (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.