Clinical trial NCT05974358: KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn's disease
Kono-S anastomosis
conventional anastomosis
endoscopic recurrence
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, multicenter,randomized study
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: endoscopy score
timeFrame: Month 6
Secondary outcomes:
measure: Harvey-Bradshaw Index (HBI)
timeFrame: Month 6
measure: Harvey-Bradshaw Index (HBI)
timeFrame: Month 12
measure: Harvey-Bradshaw Index (HBI)
timeFrame: Month 18
measure: Harvey-Bradshaw Index (HBI)
timeFrame: Month 24
measure: Crohn's Disease Activity Index (CDAI) clinical scores
timeFrame: Month 6
measure: Crohn's Disease Activity Index (CDAI) clinical scores
timeFrame: Month12
measure: Crohn's Disease Activity Index (CDAI) clinical scores
timeFrame: Month18
measure: Crohn's Disease Activity Index (CDAI) clinical scores
timeFrame: Month24
measure: Fecal calprotectin
timeFrame: Month 6
measure: Fecal calprotectin
timeFrame: Month 12
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHu de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHU de Lille Hopital Claude Huriez
city: Lyon
country: France
facility: HCL-Hôpital Lyon Sud
city: Marseille
country: France
facility: AP-HM Hôpital Nord
city: Nancy
country: France
facility: CHU de Nançy
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Ap-HP Hopital St Louis
city: Paris
country: France
facility: AP-HP Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: AP-HP Le Kremlin-Bicetre
city: Paris
country: France
facility: AP-HP St Antoine
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU de Strasbourg HautePierre
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References: