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Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease

RecruitingNAAges 16 Years - anyAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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. * Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
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What it tests

  • stapled side-to-side anastomosis
  • Handsewn anastomosis
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Where

1 site
Flevoziekenhuis
Almere Stad, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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