Optimising surgical anastomosis in ileocolic resection for Crohn's disease to reduce recurrent disease: A Randomized controlled trial comparing hand-sewn (END-TO-END or Kono-S) to stapled anastomosis (END2END study) - END2END study

Amsterdam UMC0 个研究点目标入组 165 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•1. Males and females aged >16 years
•2. Ileocolic disease or disease of the neoterminal ileum with an indication for
•3. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX,
•antibiotics, and anti-TNF therapy are permitted.
•4. All patients should have ileocolic disease or disease of the neoterminal
•ileum previously confirmed during endoscopy, with a recent update of imaging
•(e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))
•5. Ability to comply with protocol.
•6. Competent and able to provide written informed consent.
•7. Patiënt must have been discussed in the local MDT

•1. Inability to give informed consent.
•2. patients less than 16 years of age.
•3. 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.
•4. History of cancer < 5 years which might influence patients prognosis
•5. Emergent operation.
•6. Pregnant or breast feeding.

发起方

Amsterdam UMC