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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 226 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Locations | 15 sites (Besançon and 14 other locations) |
| Status | Recruiting |
| Started | March 2025 |
| Main results expected | July 2027 |
| Study ends | February 2029 |
| Registry record updated | February 13, 2025 |
| Trial ID | NCT05974358 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
- Study coordinator: Zaher LAKKIS
- Email: zlakkis@chu-besancon.fr
- Phone: +33381218988
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Microencapsulated Propionate vs Butyrate for Crohn's Disease in Remission
This study tests whether microencapsulated sodium propionate can favorably alter the gut microbiota and inflammation in adults with Crohn’s disease, compared with sodium butyrate.
-
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
This study tests whether risankizumab can help people with Crohn’s disease who have draining perianal fistulas not responding to other treatments.
-
Intestinal ultrasound-guided management for inflammatory bowel disease
This study tests if adding point-of-care intestinal ultrasound at every visit changes treatment decisions for adults with Crohn’s disease or ulcerative colitis undergoing disease assessment.
-
Laser-based sizing of GI lesions during endoscopies
This study tests whether the AccuMeasure laser tool gives more accurate and reliable lesion size measurements during colonoscopies for adults with colon polyps or Crohn’s disease than traditional endoscopic estimates.
-
A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis
A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.
-
Claudin-2 Immunostaining to Detect Active or Inactive Inflammation in IBD Biopsies
This study tests whether staining for Claudin-2 in intestinal biopsy samples can help identify active vs. inactive inflammation in people with ulcerative colitis or Crohn's disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.