KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease

Recruiting now · Not applicable

Conditions studied: Crohn Disease

In brief

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) currently affecting one person in a thousand in France. It can lead to numerous digestive complications such as fistulas, abscesses or stenosis. Despite numerous therapeutic advances, the rate of patients requiring surgery remains very high, with approximately 50% requiring at least one surgical intervention at 10 years after disease diagnosis. However, surgical treatment is not curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic recurrence at 1 year. The ileocolonic anastomosis is the main site of postoperative recurrence currently defined by a Rutgeerts score (≥i2) 6 months after surgery. In 2003, Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). The study showed no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease in surgical recurrence rate at 5 years (15% vs 0%). Recently, a randomized Italian monocenter study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2% versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. The limitations of this study are its monocentric nature and the lack of centralization of the endoscopic analysis to assess the primary endpoint. This surgical technique has been performed in some centers for ileocolonic Crohn's surgery since 2020. Nevertheless, the level of evidence remains too low to establish practice recommendations. The KOALA study will be the first prospective, multicenter, randomized study comparing KONO-S anastomosis and conventional anastomosis for ileocolonicresection of Crohn's disease, with blinded and centralized evaluation of recurrence.

Key facts

Study ID

NCT05974358

Run by

Centre Hospitalier Universitaire de Besancon

People needed

226

Starts

2025-03-01

Expected to finish

2029-02-01

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• CHu de Besançon — Besançon, France (enrolling)
• CHU de Bordeaux — Bordeaux, France
• CHU de Grenoble — Grenoble, France
• CHU de Lille Hopital Claude Huriez — Lille, France
• HCL-Hôpital Lyon Sud — Lyon, France
• AP-HM Hôpital Nord — Marseille, France
• CHU de Nançy — Nancy, France
• CHU de Nantes — Nantes, France
• Ap-HP Hopital St Louis — Paris, France
• AP-HP Hôpital Européen Georges Pompidou — Paris, France
• AP-HP Le Kremlin-Bicetre — Paris, France
• AP-HP St Antoine — Paris, France
• CHU de Rennes — Rennes, France
• CHU de Strasbourg HautePierre — Strasbourg, France
• CHU de Toulouse — Toulouse, France

Full record on ClinicalTrials.gov

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