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

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.

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 226 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Besancon (Academic / other)
• Locations: 15 sites (Besançon and 14 other locations)
• Trial ID: NCT05974358 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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 performed: 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.

Eligibility 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 this trial is running

Besançon and 14 other locations

• 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)
• 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

Conditions Crohn Disease; Crohn's disease; Kono-S anastomosis; conventional anastomosis; endoscopic recurrence