NCT05578235
Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease
Recruiting · Not Applicable · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · registry updated 2023-12-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.
Inclusion
- Males and females aged \>16 years
- Ileocolic disease or disease of the neoterminal ileum with an indication for 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 a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))- Ability to comply with protocol.
- Competent and able to provide written informed consent.
- Patient must have been discussed in the local MDT
Exclusion
- Inability to give informed consent.
- Patients less than 16 years of age.
- 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.