Extended Mesenteric Resection in Ileocecal Crohn's Disease.
Recruiting · NCT06324838 · Interventional (participants receive a specific treatment) · Lead sponsor: Odense University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively. Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants. Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring.
Who can take part
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 it is running
1 location listed.
- Odense University Hospital - Odense, Denmark