Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
NCT05578235

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

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-12-18

165

Participants Needed

1

Research Sites

220 weeks

Total Duration

On this page

Sponsors

A

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

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 compromise patient safety)
  • History of cancer less than 5 years which might influence prognosis
  • Emergent operation
  • Pregnant or breastfeeding
  • Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Flevoziekenhuis

Almere Stad, Flevoland, Netherlands, 1315 RA

Actively Recruiting

Loading map...

Research Team

A

Anouck EG Haanappel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here