Removing more mesentery during ileocecal surgery for Crohn's disease
Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.
This will test whether removing more of the mesentery during ileocecal surgery lowers the chance Crohn's disease comes back at the bowel connection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT06324838 on ClinicalTrials.gov |
What this trial studies
The EXCEED randomized, blinded trial will enroll 204 adults with ileocecal Crohn's disease who need elective resection and randomize them to standard mesocolic-sparing or extended mesocolic resection. Procedures are performed laparoscopically with at least 5 cm of disease-free bowel on each side and a stapled side-to-side isoperistaltic anastomosis; extended mesocolic excision removes visibly inflamed mesentery. The primary endpoint is endoscopic recurrence at 12 months, with additional endoscopy and clinical follow-up at 6 months and long-term chart review at 3 and 5 years. A nested cohort of 20 participants will receive extra surveillance testing to compare non-invasive methods for detecting anastomotic recurrence.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for elective ileocecal resection for limited ('simple') ileocecal Crohn's disease affecting ≤40 cm of ileum, without prior ileocecal resection, who can consent and understand Danish or another Nordic language.
Not a fit: Patients with more extensive or multifocal Crohn's disease, previous ileocecal resections, inability to understand Nordic languages, pregnancy, lactation, or those who are not surgical candidates are unlikely to benefit from this intervention or the trial.
Why it matters
Potential benefit: If successful, this approach could lower endoscopic and clinical recurrence at the anastomosis, reducing the need for repeat surgery and long-term medication.
How similar studies have performed: Retrospective and observational studies have suggested that including the mesentery may reduce recurrence, but randomized blinded trials are limited and the approach is not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients above the age of 18 scheduled for ileocecal resection due to Crohn's disease. * Relevant endoscopy and imaging within the last 6 months. * Diagnosis of "simple" ileocecal Crohn's disease (limited to ileocecal disease with a maximum of 40 cm of affected ileum). Exclusion Criteria * Previous ileocecal resection. * Inability to understand Danish or another Nordic language. * Inability to comprehend the purpose and design of the project. * Pregnancy or lactation.
Where this trial is running
Odense
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Jens K Bælum, MD
- Email: jens.kristian.baelum@rsyd.dk
- Phone: +4521758114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.