Comparing hand-sewn and stapled methods for ileocolic surgery in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial aims to compare hand-sewn (end-to-end and Kono-S) anastomosis with stapled side-to-side anastomosis following ileocolic resection in patients with Crohn's disease. The study will evaluate the endoscopic recurrence of the disease, functional outcomes, and healthcare consumption over a period of six months. By analyzing different surgical techniques, the trial seeks to determine which method may lead to better patient outcomes and reduced recurrence rates.

Why it matters

Who can join: the full rules

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.

Where it's running

• Flevoziekenhuis
  Almere Stad, Flevoland, Netherlands Recruiting

Study contacts

• Principal investigator: W.A. Bemelman, Prof. dr. — Amsterdam UMC, location AMC
• Study coordinator: Anouck EG Haanappel, MD
• Email: a.e.g.haanappel@amsterdamumc.nl
• Phone: 0031650828323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.