RecruitingNot ApplicableNCT05578235

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

Optimising Surgical Anastomosis in Ileocolic Resection for Crohn's Disease to Reduce Recurrent Disease: A Randomised Controlled Trial Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis (END-to-END Study)

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

165 participants

Start Date

Jul 13, 2023

Study Type

INTERVENTIONAL

Conditions

Crohn Disease

Summary

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.

Eligibility

Min Age: 16 Years

Inclusion Criteria6

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 Criteria7

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.