NCT04538638Completed
Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
Source: ClinicalTrials.gov · Last updated 26 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 139 (actual)
- First submitted
- 31 Aug 2020
- Start date
- 1 Mar 2020
- Primary completion date
- 1 May 2023
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Crohn's disease
- NCT number
- NCT04538638
What you commit to
- Study type: Interventional
- Participants enrolled: 139
- From 1 Mar 2020 to the primary completion date, 1 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing repeated ileocolic resection.
- 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.
Age
- patients less than 16 years of age.
- History of cancer \< 5 years which might influence patients prognosis
Other
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Inability to give informed consent.
- Emergent operation.
- Pregnant or breast feeding.
- Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
Who the study is looking for
- In order to be eligible to participate in this study, a subject must meet all of the following 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC, location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.