Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Comparing Kono-S anastomosis to standard surgery for Crohn's disease

Official title: KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease: a Superiority Phase III Prospective, Randomized, Multicenter, Double-blind Trial.

Run by Centre Hospitalier Universitaire de Besancon · NCT05974358 · Data updated 2026-11-12

This study is testing a new surgical technique called Kono-S to see if it can help adults with Crohn's disease have fewer problems after surgery compared to standard surgery.

More Crohn Disease trials

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment226 (estimated)
SponsorCentre Hospitalier Universitaire de Besancon
Academic / other
Locations15 sites (Besançon and 14 other locations)
StatusRecruiting
StartedMarch 2025
Main results expectedJuly 2027
Study endsFebruary 2029
Registry record updatedFebruary 13, 2025
Trial IDNCT05974358 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 to 75 with Crohn's disease requiring their first ileocolonic resection.

Probably not a fit

Patients who have previously undergone ileocolonic resection or have contraindications to postoperative endoscopy may not benefit from this study.

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

What this trial studies

This clinical trial aims to compare the Kono-S anastomosis technique with conventional ileocolonic anastomosis in patients undergoing surgery for Crohn's disease. The Kono-S technique is designed to reduce the high rates of postoperative recurrence associated with traditional surgical methods. Participants will be adults aged 18 to 75 who require their first ileocolonic resection due to complications from Crohn's disease. The study will assess the effectiveness of the Kono-S approach in preventing endoscopic recurrence of the disease post-surgery.

Why it matters

Potential benefit: If successful, this study could significantly lower the recurrence rates of Crohn's disease after surgery, improving long-term patient outcomes.

How similar studies have gone: While the Kono-S anastomosis technique has shown promise in preliminary studies, this specific comparison with conventional methods is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patient ≥ 18 years and ≤75 years
* With Crohn's disease.
* Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease or disease refractory to medical treatment.
* Affiliated to the French social security system.

Exclusion Criteria:

* Previous ileocolonic resection
* Contraindication to postoperative endoscopy.
* Anastomosis with a planned defunctioning protective stoma.
* Emergency surgery (peritonitis).
* Lack of consent to the study.
* Pregnant patients.
* Refusal to participate or inability to provide informed consent.
* Patient under legal protection (individuals under guardianship by court order)

Where it's running

  • CHu de Besançon
    Besançon, France
    Recruiting
  • CHU de Bordeaux
    Bordeaux, France
    Not yet recruiting
  • CHU de Grenoble
    Grenoble, France
    Not yet recruiting
  • CHU de Lille Hopital Claude Huriez
    Lille, France
    Not yet recruiting
  • HCL-Hôpital Lyon Sud
    Lyon, France
    Not yet recruiting
  • AP-HM Hôpital Nord
    Marseille, France
    Not yet recruiting
Show 9 more locations
  • CHU de Nançy
    Nancy, France
    Not yet recruiting
  • CHU de Nantes
    Nantes, France
    Not yet recruiting
  • Ap-HP Hopital St Louis
    Paris, France
    Not yet recruiting
  • AP-HP Hôpital Européen Georges Pompidou
    Paris, France
    Not yet recruiting
  • AP-HP Le Kremlin-Bicetre
    Paris, France
    Not yet recruiting
  • AP-HP St Antoine
    Paris, France
    Not yet recruiting
  • CHU de Rennes
    Rennes, France
    Not yet recruiting
  • CHU de Strasbourg HautePierre
    Strasbourg, France
    Not yet recruiting
  • CHU de Toulouse
    Toulouse, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.