NCT05974358

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Mar 2025Feb 2029

First Submitted

Initial submission to the registry

July 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

July 26, 2023

Last Update Submit

February 11, 2025

Conditions

Crohn Disease

Keywords

Crohn's diseaseKono-S anastomosisconventional anastomosisendoscopic recurrence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Harvey-Bradshaw Index (HBI)

    Month 6

  • Harvey-Bradshaw Index (HBI)

    Month 12

  • Harvey-Bradshaw Index (HBI)

    Month 18

  • Harvey-Bradshaw Index (HBI)

    Month 24

  • Crohn's Disease Activity Index (CDAI) clinical scores

    Month 6

  • +5 more secondary outcomes

Study Arms (2)

Kono-S group

EXPERIMENTAL

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

Procedure: Kono-S anastomosis

Control group

OTHER

Conventional side-to-side ileocolonic anastomosis

Procedure: Conventional anastomosis for ileocolonicresection of Crohn's disease

Interventions

Kono-S anastomosisPROCEDURE

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-S group
Conventional anastomosis for ileocolonicresection of Crohn's diseasePROCEDURE

conventional anastomosis for ileocolonicresection of Crohn's disease

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHu de Besançon

Besançon, 25030, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU de Grenoble

Grenoble, France

NOT YET RECRUITING

CHU de Lille Hopital Claude Huriez

Lille, France

NOT YET RECRUITING

HCL-Hôpital Lyon Sud

Lyon, France

NOT YET RECRUITING

AP-HM Hôpital Nord

Marseille, France

NOT YET RECRUITING

CHU de Nançy

Nancy, France

NOT YET RECRUITING

CHU de Nantes

Nantes, France

NOT YET RECRUITING

Ap-HP Hopital St Louis

Paris, France

NOT YET RECRUITING

AP-HP Hôpital Européen Georges Pompidou

Paris, France

NOT YET RECRUITING

AP-HP Le Kremlin-Bicetre

Paris, France

NOT YET RECRUITING

AP-HP St Antoine

Paris, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

NOT YET RECRUITING

CHU de Strasbourg HautePierre

Strasbourg, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Zaher LAKKIS

CONTACT

+33381218988zlakkis@chu-besancon.fr

Astrid POZET

CONTACT

+33381218988apozet@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, multicenter,randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

March 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

February 1, 2029

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

FR(15)