RecruitingNot ApplicableNCT06324838

Extended Mesenteric Resection in Ileocecal Crohn's Disease.

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


Sponsor

Odense University Hospital

Enrollment

204 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • Previous ileocecal resection.
  • Inability to understand Danish or another Nordic language.
  • Inability to comprehend the purpose and design of the project.
  • Pregnancy or lactation.

Interventions

PROCEDUREStandard laparoscopic ileocecal resection

Participants will undergo standard mesocolic sparing resection.

PROCEDUREExtended laparoscopic ileocecal resection

Extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site.


Locations(1)

Odense University Hospital

Odense, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06324838