RecruitingNot ApplicableNCT05974358

KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in 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.


Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

226 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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)

Interventions

PROCEDUREKono-S anastomosis

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).

PROCEDUREConventional anastomosis for ileocolonicresection of Crohn's disease

conventional anastomosis for ileocolonicresection of Crohn's disease


Locations(15)

CHu de Besançon

Besançon, France

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

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NCT05974358


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