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Comparing stitched and stapled bowel joins in Crohn's disease surgery

Tests hand-sewn versus stapled bowel joins after surgery in people with Crohn's disease.

Plain-language title generated from the registry record
Registry title: Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease

Key facts

Where
Almere Stad, NetherlandsSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults and teenagers over 16 with Crohn's disease who need surgery to remove part of the bowel (ileocolic resection). It compares hand-sewn and stapled joins of the bowel.

Age
Older than 16 years
Sex
Men and women
Disease stage
Crohn's disease in the ileocolic area or the last part of the small bowel, with a need for surgical removal (resection).
Earlier treatment
Treatments with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics and anti-TNF therapy are allowed. A recent colonoscopy and updated imaging are needed.

Main reasons for not taking part

  • Cannot give informed consent
  • Emergency operation
  • Serious medical condition in the six months before the operation, such as heart attack or heart failure
  • Cancer in the last 5 years that could affect the outlook
  • Pregnant or breastfeeding

Read by machine on 12 November 2026.

Where in Netherlands

  • FlevoziekenhuisAlmere Stad, NetherlandsContact: Jarmila van der Bilt, dr. (principal investigator)Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Trial code
NCT05578235
Record updated
18 December 2023
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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: 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; Patients less than 16 years of age; History of cancer < 5 years which might influence patients prognosis; Inability to give informed consent; Emergent operation; Pregnant or breast feeding; Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

ClinicalTrials.gov NCT05578235