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.

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHu de Besançon
RECRUITING
Besançon
CHU de Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU de Grenoble
NOT_YET_RECRUITING
Grenoble
CHU de Lille Hopital Claude Huriez
NOT_YET_RECRUITING
Lille
HCL-Hôpital Lyon Sud
NOT_YET_RECRUITING
Lyon
AP-HM Hôpital Nord
NOT_YET_RECRUITING
Marseille
CHU de Nançy
NOT_YET_RECRUITING
Nancy
CHU de Nantes
NOT_YET_RECRUITING
Nantes
AP-HP Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
Ap-HP Hopital St Louis
NOT_YET_RECRUITING
Paris
AP-HP Le Kremlin-Bicetre
NOT_YET_RECRUITING
Paris
AP-HP St Antoine
NOT_YET_RECRUITING
Paris
CHU de Rennes
NOT_YET_RECRUITING
Rennes
CHU de Strasbourg HautePierre
NOT_YET_RECRUITING
Strasbourg
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Zaher LAKKIS
zlakkis@chu-besancon.fr
+33381218988
Backup
Astrid POZET
apozet@chu-besancon.fr
+33381218988
Time Frame
Start Date: 2025-03
Estimated Completion Date: 2029-02
Participants
Target number of participants: 226
Treatments
Experimental: Kono-S group
Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.
Other: Control group
Conventional side-to-side ileocolonic anastomosis
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Besancon

This content was sourced from clinicaltrials.gov

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