Clinical Trials in the Netherlands / NCT05578235
Recruiting Not applicable

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

NCT05578235 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2023-07-13
Last updated
2023-12-18

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

stapled side-to-side anastomosisHandsewn anastomosis

stapled side-to-side anastomosis: Standard procedure for CD

Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis

Study 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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Flevoziekenhuis Almere Stad Flevoland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05578235 on ClinicalTrials.gov ↗ ← All trials in the Netherlands