Extended Mesenteric Resection in Ileocecal Crohn's Disease.
NCT06324838 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2026-01-15
Summary
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.
Conditions
- Crohn's Disease of Terminal Ileum
Interventions
- PROCEDURE
-
Standard laparoscopic ileocecal resection
Participants will undergo standard mesocolic sparing resection.
- PROCEDURE
-
Extended laparoscopic ileocecal resection
Extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site.
Sponsors & Collaborators
-
Odense University Hospital
lead OTHER
Principal Investigators
-
Mark B Ellebæk, PhD · Surgical Research Unit, Odense University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-06-30
Countries
- Denmark
Study Locations
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