Extended Mesenteric Resection in Ileocecal Crohn's Disease.

NCT ID: NCT06324838

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2029-06-30

Brief 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.

Detailed Description

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.

Conditions

Crohn's Disease of Terminal Ileum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Extended mesenteric resection

Arm receiving ileocecal resection with extended mesenteric resection.

Group Type: EXPERIMENTAL

Extended laparoscopic ileocecal resection

Intervention Type: PROCEDURE

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

Controls (Standard mesenteric resection)

Arm receiving standard ileocecal resection.

Group Type: ACTIVE_COMPARATOR

Standard laparoscopic ileocecal resection

Intervention Type: PROCEDURE

Participants will undergo standard mesocolic sparing resection.

Interventions

Standard laparoscopic ileocecal resection

Participants will undergo standard mesocolic sparing resection.

Intervention Type: PROCEDURE

Extended laparoscopic ileocecal resection

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

Intervention Type: PROCEDURE

Other Intervention Names

Laparoscopic ileocecal resection

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark B Ellebæk, PhD

Role: STUDY_DIRECTOR

Surgical Research Unit, Odense University Hospital

Locations

Odense University Hospital

Odense, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jens K Bælum, MD

Role: CONTACT

jens.kristian.baelum@rsyd.dk

+4521758114

Mark B Ellebæk, PhD

Role: CONTACT

mark.ellebaek1@rsyd.dk

Facility Contacts

Jens Kristian Bælum, MD

Role: primary

jens.kristian.baelum@rsyd.dk

+4540169388

References

Baelum JK, Rosenberg J, Larsen P, Joergensen M, De La Croix H, Haglind E, Agenete E; BEAT-IBD research group. Extended mesenteric resection in Crohn's disease: EXCEED Study Protocol-a blinded multicenter randomized controlled clinical trial (RCT). Trials. 2025 Nov 21;26(1):532. doi: 10.1186/s13063-025-09261-3.

Reference Type: DERIVED

PMID: 41272703 (View on PubMed)

Other Identifiers

248-2021-NQ

Identifier Type: -

Identifier Source: org_study_id