Comparing two surgical techniques for 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 study is a multi-center randomized trial that compares the Kono-S anastomosis with the standard side-to-side functional end anastomosis in patients with Crohn's ileitis or ileocolitis requiring surgical resection. The primary aim is to assess postoperative recurrence of Crohn's disease using the Rutgeerts score at various time points, while secondary aims include evaluating quality of life, disease activity, and patient perspectives on surgical treatment. Participants will be followed for up to 120 months to monitor surgical outcomes and recurrence rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.
2. Age of 18 years and older, male and female
3. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing (B2), and penetrating (fistulating) (B3), according to the Vienna classification
4. The patients can be on any medications coming into surgery, including prior anti- tumor necrosis factor(TNF) therapy.

Exclusion Criteria:

1. Patients under 18 years of age
2. Patients with recurrent Crohn's
3. Pregnant patients
4. Patients with more than one non-contiguous site of active disease, thus requiring multiple resections or additional bowel sparing procedures at the time of surgery.
5. Patients with Crohn's disease extending to the cecum and ascending colon
6. Patients who will need preventive postoperative medical treatment
7. Patients that need change of surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation.

Where it's running

• Weill Cornell Medical College
  New York, New York, United States Recruiting
• University Clinics Gasthuisberg Herestraat
  Leuven, Belgium Recruiting
• Universitätsklinik Würzburg
  Würzburg, Wurzburg, Germany Recruiting
• Charité Campus Benjamin Franklin
  Berlin, Germany Recruiting
• Theresien Hospital and St. Hedwigs Clinic gGmbH
  Mannheim, Germany Recruiting
• Azienda Ospedaliero-Universitaria Careggi
  Florence, Florence, Italy Recruiting

Study contacts

• Principal investigator: Fabrizio Michelassi, MD — Weill Medical College of Cornell University
• Study coordinator: Koianka Trencheva, Dr.PH,BSN,MS
• Email: kivanova@med.cornell.edu
• Phone: 646-962-2342

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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.