Extended Mesenteric Resection in Ileocecal Crohn's Disease.
Not applicable · Testing Standard laparoscopic ileocecal resection and Extended laparoscopic ileocecal resection · 1 site · Odense University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Standard laparoscopic ileocecal resection (a procedure) and Extended laparoscopic ileocecal resection (a procedure) as a possible treatment. Condition(s) listed: Crohn's Disease of Terminal Ileum.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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).
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 204 participants are expected to take part.
- Start date: 2025-02-01.
- Main results expected around 2028-12 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Denmark.
Main thing being measured
- Endoscopic recurrence (12 months postoperative)
In the researchers’ words
The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease of Terminal Ileum |
| Lead sponsor | Odense University Hospital |
| Enrollment | 204 (estimated) |
| Start date | 2025-02-01 |
| Primary completion (est.) | 2028-12 |
| First posted | 2024-03-22 |
| Last updated | 2026-01-15 |
| Official title | Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial. |
| ClinicalTrials.gov ID | NCT06324838 |
Interventions
- Standard laparoscopic ileocecal resection (Procedure)
Participants will undergo standard mesocolic sparing resection. - Extended laparoscopic ileocecal resection (Procedure)
Extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital | Odense | Denmark | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.