Crohn DiseaseNCT04539665
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
A study testing Extended mesenteric resection. in people with Crohn Disease and Recurrence, run by Montreal General Hospital at 2 sites in Canada.
Trial summary
The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Recurrence, Crohn's Ileocolitis
- What is being tested?
- Extended mesenteric resection.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Sep 2019to 30 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults >18 years old
- diagnosis of CD limited to the distal ileum/ileocolic region
- no previous ileocolic resection
- all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.
Who cannot join
- previous ileocolic resection
- other sites of CD
- intraabdominal sepsis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Sender Liberman, MD, (514) 934-8486, sender.liberman@mcgill.ca
Bessissow Talat, MD, (514) 934-8309, talat.bessissow@mcgill.ca
- Not yet recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Marylise Boutros, MD, (514) 340-8222 ext. 28400, marylise.boutros@mcgill.ca
About this study
Official title: Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study
The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.
Read the detailed description
The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.
- Conditions
- Crohn Disease, Recurrence, Crohn's Ileocolitis
- Being tested
- Extended mesenteric resection.
- Medical subject headings
- Crohn Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended mesenteric resection.Procedure or surgery
Patients will undergo an ileocolic resection involving high ligation of the ileocolic pedicle, complete mobilization of the mesentery off of the retroperitoneum, and resection of the entire mesentery related to the specimen.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Prospective study arm involving an extended mesenteric ileocolic excision. Receives: Procedure: Extended mesenteric resection. |
| Control Arm | No intervention | Historical controls from a retrospective chart review of patients who had a limited ileocolic resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with endoscopic recurrence at 6 months
Endoscopic recurrence after extended mesenteric ileocolic resection
Measured: 6 months
Secondary outcomes (3)
Number of participants with endoscopic recurrence at 18 months
Endoscopic recurrence after extended mesenteric ileocolic resection.
Measured: 18 months
Rates of recurrence requiring surgery by 2 years
Surgical recurrence after extended mesenteric ileocolic resection.
Measured: 24 months
Rates of post-operative complications compared between study groups
Post-operative complications including: wound infections, anastomotic leak, intra-abdominal abscess, venous-thromboembolic complications, and primary ileus within 30 days of the first resection.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start27 Sep 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish General Hospital
- Responsible party
- Principal investigator, Sender Liberman MD, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539665
- Sponsor's protocol ID
- crohn's mesentery
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2020
- Last updated
- 7 Apr 2022
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04539665
- Acronym / sponsor ID
- crohn's mesentery
- Conditions
- Crohn Disease, Recurrence, Crohn's Ileocolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Collaborators
- Jewish General Hospital
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Sep 2020 (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 looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.
Detailed description
The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Procedure: Extended mesenteric resection.Prospective study arm involving an extended mesenteric ileocolic excision. |
| Control Arm | No intervention | –Historical controls from a retrospective chart review of patients who had a limited ileocolic resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults >18 years old
- diagnosis of CD limited to the distal ileum/ileocolic region
- no previous ileocolic resection
- all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.
Key exclusion criteria (3 listed)
- previous ileocolic resection
- other sites of CD
- intraabdominal sepsis
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 |
|---|---|---|
| Extended mesenteric resection.Patients will undergo an ileocolic resection involving high ligation of the ileocolic pedicle, complete mobilization of the mesentery off of the retroperitoneum, and resection of the entire mesentery related to the specimen. | Procedure or surgery | Intervention Arm |
Primary outcome
Number of participants with endoscopic recurrence at 6 months
Time frame: 6 months
Endoscopic recurrence after extended mesenteric ileocolic resection
3 secondary outcomes
Number of participants with endoscopic recurrence at 18 months
Time frame: 18 months
Rates of recurrence requiring surgery by 2 years
Time frame: 24 months
Rates of post-operative complications compared between study groups
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended mesenteric resection. in people with Crohn Disease and Recurrence, run by Montreal General Hospital at 2 sites 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sender Liberman, MD ((514) 934-8486, sender.liberman@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with endoscopic recurrence at 6 months (time frame: 6 months). 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 7 Apr 2022.