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Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Jens K Bælum, MD
jens.kristian.baelum@rsyd.dk
+4521758114
Backup
Mark B Ellebæk, PhD
mark.ellebaek1@rsyd.dk
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2029-06
Participants
Target number of participants: 204
Treatments
Experimental: Extended mesenteric resection
Arm receiving ileocecal resection with extended mesenteric resection.
Active_comparator: Controls (Standard mesenteric resection)
Arm receiving standard ileocecal resection.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital

This content was sourced from clinicaltrials.gov

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