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RECRUITINGINTERVENTIONAL

Extended Mesenteric Resection in Ileocecal Crohn's Disease.

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

Odense University Hospital
Odense, Denmark