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

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Procedure: Conventional anastomosis for ileocolonicresection of Crohn's disease; Procedure: Kono-S anastomosis

• Registration Number: NCT05974358
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Study Start: 2025-03
• Primary Completion: 2027-07
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 226

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Conventional anastomosis for ileocolonicresection of Crohn's disease	Conventional side-to-side ileocolonic anastomosis
Kono-S group	Kono-S anastomosis	Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.

Primary Outcome Measures

Name	Time	Method
endoscopy score	Month 6	Rutgeerts endoscopy score ≥ i2 (\>5 anastomotic lesions with passable stenosis (skip lesions); or lesions in the area of the anastomosis) at 6 months obtained by centralized double reading of filmed endoscopy.; I0 no lesions; * 1 \<5 aphthous lesions in the neoterminal ileum; * 2 \>5 anastomotic lesions with passable stenosis (skip lesions); or lesions in the area of the anastomosis; * 3 diffuse ileitis; * 4 diffuse ileitis with deep ulcerations and/or Stenosis

Secondary Outcome Measures

Name	Time	Method
Harvey-Bradshaw Index (HBI)	Month 24	Harvey-Bradshaw Index (HBI) Disease not active: \<4 ; Mild disease activity: HBI \>= 4 and \<= 8 ; Moderate disease activity: HBI \> 8 and \<= 12 ; Severe disease activity: HBI \> 12
Crohn's Disease Activity Index (CDAI) clinical scores	Month24	Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI \< 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (\>450).
Fecal calprotectin	Month 12	Fecal calprotectin

Trial Locations

Locations (15)

CHu de Besançon; 🇫🇷 Besançon, France

CHU de Lille Hopital Claude Huriez; 🇫🇷 Lille, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Grenoble; 🇫🇷 Grenoble, 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