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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05974358

Collaborator

(none)

226

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Procedure: Kono-S anastomosis Procedure: Conventional anastomosis for ileocolonicresection of Crohn's disease	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

226 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, multicenter,randomized studyprospective, multicenter,randomized study

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 31, 2028

Anticipated Study Completion Date :

Jan 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kono-S group Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.	Procedure: Kono-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) (Kono. DCR 2011)
Other: Control group Conventional side-to-side ileocolonic anastomosis	Procedure: Conventional anastomosis for ileocolonicresection of Crohn's disease conventional anastomosis for ileocolonicresection of Crohn's disease

Arm

Intervention/Treatment

Experimental: Kono-S group

Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.

Procedure: Kono-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) (Kono. DCR 2011)

Other: Control group

Conventional side-to-side ileocolonic anastomosis

Procedure: Conventional anastomosis for ileocolonicresection of Crohn's disease

conventional anastomosis for ileocolonicresection of Crohn's disease

Outcome Measures

Primary Outcome Measures

endoscopy score [Month 6]
Rutgeerts endoscopy score ≥ i2 at 6 months obtained by centralized double reading of filmed endoscopy.

Secondary Outcome Measures

Harvey-Bradshaw Index (HBI) [Month 6]
Harvey-Bradshaw Index (HBI)
Harvey-Bradshaw Index (HBI) [Month 12]
Harvey-Bradshaw Index (HBI)
Harvey-Bradshaw Index (HBI) [Month 18]
Harvey-Bradshaw Index (HBI)
Harvey-Bradshaw Index (HBI) [Month 24]
Harvey-Bradshaw Index (HBI)
Crohn's Disease Activity Index (CDAI) clinical scores [Month 6]
Crohn's Disease Activity Index (CDAI) clinical scores
Crohn's Disease Activity Index (CDAI) clinical scores [Month12]
Crohn's Disease Activity Index (CDAI) clinical scores
Crohn's Disease Activity Index (CDAI) clinical scores [Month18]
Crohn's Disease Activity Index (CDAI) clinical scores
Crohn's Disease Activity Index (CDAI) clinical scores [Month24]
Crohn's Disease Activity Index (CDAI) clinical scores
Fecal calprotectin [Month 6]
Fecal calprotectin
Fecal calprotectin [Month 12]
Fecal calprotectin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.