Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in C… (NCT04538638) | Clinical Trial Compass
CompletedNot Applicable
Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
Netherlands139 participantsStarted 2020-03-01
Plain-language summary
The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Ileocolic disease with an indication for ileocecal resection
✓. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
✓. All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
✓. Ability to comply with protocol.
✓. Competent and able to provide written informed consent.
✓. Patient must have been discussed in the local MDT
✕. Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
✕. History of cancer \< 5 years which might influence patients prognosis
✕. Emergent operation.
✕. Pregnant or breast feeding.
What they're measuring
1
The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection
Timeframe: 6 months after surgery
Trial details
NCT IDNCT04538638
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)