TrialPath
Recruiting

Extended Mesenteric Resection in Ileocecal Crohn's Disease.

NCT06324838 · Odense University Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Extended Mesenteric Resection in Ileocecal Crohn's Disease to Prevent Recurrent Disease - A Randomized Controlled Trial.
About this study
Surgical Procedure and Perioperative Care Laparoscopic approach with a minimum 5 cm disease-free bowel on each side. Standard stapled side-to-side isoperistaltic anastomoses. Extended mesenteric excision involves resection of inflamed mesentery up to the level of visible inflammation. Both treatment groups will receive standard postoperative care according to the standards of the hospital treating the participant. Postoperative Follow-up Postoperative follow-up at 6 and 12 months. This consist of an ileo-colonoscopy, chart review and questionnaires. The early follow-up at 6 months aims to detect early recurrence, enabling early medical treatment or other intervention. The 12-month follow-up will be the primary endpoint to determine recurrence. Long-term outcomes will be assessed through a chart review after 3 and 5 years, documenting reoperations, clinical symptoms, pharmacological use, and other complications. Postoperative Medicinal Use Postoperative medical prophylaxis assessment isn't explicitly detailed in the current protocol, though it will be acknowledged. Analysis will stratify participants based on pre- and post-operative biological/non-biological treatment. The treating physician will determine postoperative medical therapy, typically maintaining pre-operative medication. Postoperative Endoscopy Endoscopy will be regarded as the golden standard for the detection of disease recurrence. The endoscopies, including bowel preparation and possible sedation, will be preformed in accordance with local guidelines at each hospital. At least three biopsies will be taken from the ileum (5 cm proximal to the anastomosis), anastomosis, and colon (5 cm below the anastomosis). A short video of each endoscopy will be saved for validation purposes. Lesions found during the endoscopy will be classified using the modified Rutgeerts score\[7\]. Patient-Reported Outcome During the preoperative workup (baseline), the participant will be asked to complete 2 questionnaires (5Q-5D-5L and SIBDQ). Postoperatively, the participant will be asked to complete the same questionnaires at 6 and 12 months. Statistical analysis plan Outcome Analysis The investigators plan to conduct a chi-square or Fisher's exact test to compare the proportion of participants with endoscopic recurrence between the intervention and control groups. The investigators will utilize logistic regression to adjust for potential confounding variables if needed. Demographics The Investigators will use means and standard deviations (or medians and interquartile ranges) for continuous variables. For categorical variables, frequencies and percentages will be presented and demographic characteristics between intervention and control groups will be compared.
Eligibility criteria
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.
Study design
Enrollment target: 204 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-02-01
Estimated completion: 2029-06
Last updated: 2026-01-15
Interventions
Procedure: Standard laparoscopic ileocecal resectionProcedure: Extended laparoscopic ileocecal resection
Primary outcomes
  • Endoscopic recurrence (12 months postoperative)
Sponsor
Odense University Hospital · other
Contacts & investigators
ContactJens K Bælum, MD · contact · jens.kristian.baelum@rsyd.dk · +4521758114
ContactMark B Ellebæk, PhD · contact · mark.ellebaek1@rsyd.dk
InvestigatorMark B Ellebæk, PhD · study_director, Surgical Research Unit, Odense University Hospital
All locations (1)
Odense University HospitalRecruiting
Odense, Denmark