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

Crohn Disease Clinical Trial

— KOALA  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05974358
• Other study ID #: 2023/802
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Zaher LAKKIS
• Phone: +33381218988
• Email: zlakkis[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 226
• Est. completion date: January 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease
• Recurrence

Intervention

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).
• Conventional anastomosis for ileocolonicresection of Crohn's disease
conventional anastomosis for ileocolonicresection of Crohn's disease

Locations

Country	Name	City	State
France	CHu de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscopy score	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	Month 6
Secondary	Harvey-Bradshaw Index (HBI)	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	Month 6
Secondary	Harvey-Bradshaw Index (HBI)	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	Month 12
Secondary	Harvey-Bradshaw Index (HBI)	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	Month 18
Secondary	Harvey-Bradshaw Index (HBI)	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	Month 24
Secondary	Crohn's Disease Activity Index (CDAI) clinical scores	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).	Month 6
Secondary	Crohn's Disease Activity Index (CDAI) clinical scores	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).	Month12
Secondary	Crohn's Disease Activity Index (CDAI) clinical scores	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).	Month18
Secondary	Crohn's Disease Activity Index (CDAI) clinical scores	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).	Month24
Secondary	Fecal calprotectin	Fecal calprotectin	Month 6
Secondary	Fecal calprotectin	Fecal calprotectin	Month 12