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Extended Mesenteric Resection in Ileocecal Crohn's Disease.

ConditionCrohn's Disease of Terminal Ileum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Previous ileocecal resection.

Inability to understand Danish or another Nordic language.

Inability to comprehend the purpose and design of the project.

Pregnancy or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard laparoscopic ileocecal resection

    Procedure/Surgery

    Participants will undergo standard mesocolic sparing resection.

  • Extended laparoscopic ileocecal resection

    Procedure/Surgery

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

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Extended mesenteric resectionExperimental treatment 1 intervention
Group B: Controls (Standard mesenteric resection)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Endoscopic recurrence

Endoscopic signs of recurrence, defined as a modified Rutgeerts score \>i2a.

Time frame
12 months postoperative

Secondary outcomes

1

Early endoscopic recurrence

Endoscopic signs of recurrence, defined as a modified Rutgeerts score \>i2a.

Time frame
6 months postoperative
2

Clinical signs of recurrence / morbidity.

Resumption of medicinal treatment. Chart review will be done to identify postoperative medicinal use.

Time frame
6-48 months postoperatively
3

Difference in disease severity

At the time of operation according to the Montreal classification.

Time frame
Perioperative
4

Patient reported outcome 1

5Q-5D-5L

Time frame
6 and 12 months postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

Source ClinicalTrials.gov
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