Extended Mesenteric Resection in Ileocecal Crohn's Disease. (EXCEED)

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

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease of Terminal Ileum
• Intervention / Treatment: Procedure: Extended laparoscopic ileocecal resection; Procedure: Standard laparoscopic ileocecal resection

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.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jens K Bælum, MD; Phone Number: +4521758114; Email: jens.kristian.baelum@rsyd.dk
• Study Contact Backup: Name: Mark B Ellebæk, PhD; Email: mark.ellebaek1@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Jens Kristian Bælum, MD; Phone Number: +4540169388; Email: jens.kristian.baelum@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended mesenteric resection; Arm receiving ileocecal resection with extended mesenteric resection.	Procedure: Extended laparoscopic ileocecal resection; Extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site.
Active Comparator: Controls (Standard mesenteric resection); Arm receiving standard ileocecal resection.	Procedure: Standard laparoscopic ileocecal resection; Participants will undergo standard mesocolic sparing resection.; Other Names: Laparoscopic ileocecal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic recurrence	Endoscopic signs of recurrence, defined as a modified Rutgeerts score >i2a.	12 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early endoscopic recurrence	Endoscopic signs of recurrence, defined as a modified Rutgeerts score >i2a.	6 months postoperative
Clinical signs of recurrence / morbidity.	Resumption of medicinal treatment. Chart review will be done to identify postoperative medicinal use.	6-48 months postoperatively
Difference in disease severity	At the time of operation according to the Montreal classification.	Perioperative
Patient reported outcome 1	5Q-5D-5L	6 and 12 months postoperative
Patient reported outcome 2	SIBDQ	6 and 12 months postoperative
Reoperations	Chart review will be done to identify any reoperations due to recurrence or other complications.	6 and 12 months postoperative
Perioperative complications	Postoperative complications according to Clavien-Dindo classification.	30 days postoperative
Cost of treatment	Difference in treatment cost between the two groups. Reported in USD.	12 months postoperative.

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Study Director: Mark B Ellebæk, PhD, Surgical Research Unit, Odense University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ileocecal resection; Mesocolic resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 248-2021-NQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The principal investigators are committed to communicating the results, negative, positive, or inconclusive results, at local, national and international scientific meetings. The findings will be published in well-established, international peer-reviewed open access journals. After end of study, de-identified patient data will be uploaded to an open repository for further use.
• IPD Sharing Time Frame: After study completion.
• IPD Sharing Access Criteria: Available to all upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No