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

Last updated: February 11, 2025
Sponsor: Centre Hospitalier Universitaire de Besancon
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Kono-S anastomosis

Conventional anastomosis for ileocolonicresection of Crohn's disease

Clinical Study ID

NCT05974358
2023/802
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patient ≥ 18 years and ≤75 years

  • With Crohn's disease.

  • Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosingdisease or disease refractory to medical treatment.

  • Affiliated to the French social security system.

Exclusion

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)

Study Design

Total Participants: 226
Treatment Group(s): 2
Primary Treatment: Kono-S anastomosis
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • CHu de Besançon

    Besançon, 25030
    France

    Active - Recruiting

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CHU de Grenoble

    Grenoble,
    France

    Site Not Available

  • CHU de Lille Hopital Claude Huriez

    Lille,
    France

    Site Not Available

  • HCL-Hôpital Lyon Sud

    Lyon,
    France

    Site Not Available

  • AP-HM Hôpital Nord

    Marseille,
    France

    Site Not Available

  • CHU de Nançy

    Nancy,
    France

    Site Not Available

  • CHU de Nantes

    Nantes,
    France

    Site Not Available

  • AP-HP Hôpital Européen Georges Pompidou

    Paris,
    France

    Site Not Available

  • AP-HP Le Kremlin-Bicetre

    Paris,
    France

    Site Not Available

  • AP-HP St Antoine

    Paris,
    France

    Site Not Available

  • Ap-HP Hopital St Louis

    Paris,
    France

    Site Not Available

  • CHU de Rennes

    Rennes,
    France

    Site Not Available

  • CHU de Strasbourg HautePierre

    Strasbourg,
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse,
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.