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Crohn DiseaseKOALANCT05974358

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

A study testing Kono-S anastomosis and Conventional anastomosis for ileocolonicresection of Crohn's disease in people with Crohn Disease, run by Centre Hospitalier Universitaire de Besancon at 15 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease
What is being tested?
Kono-S anastomosis and Conventional anastomosis for ileocolonicresection of Crohn's disease
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
15 sitesFrance
Study dates
Mar 2025to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zaher LAKKIS contact

+33381218988

zlakkis@chu-besancon.fr

Astrid POZET contact

+33381218988

apozet@chu-besancon.fr

15 sites in 1 country

France15 sites, 15 recruiting

  • CHu de Besançon

    Besançon, 25030

    Zaher LAKKIS, zlakkis@chu-besancon.fr

    Recruiting

  • CHU de Bordeaux

    Bordeaux

    Benjamin FERNANDEZ, benjamin.fernandez@chu-bordeaux.fr

    Not yet recruiting

  • CHU de Grenoble

    Grenoble

    Bertrand TRILLING, btrilling@chu-grenoble.fr

    Not yet recruiting

  • CHU de Lille Hopital Claude Huriez

    Lille

    Philippe ZERBIB, philippe.zerbib@chru-lille.fr

    Not yet recruiting

  • HCL-Hôpital Lyon Sud

    Lyon

    Eddy Cotte, eddy.cotte@chu-lyon.fr

    Not yet recruiting

  • AP-HM Hôpital Nord

    Marseille

    Laura BEYER-BEJOT, laura.beyer@ap-hm.fr

    Not yet recruiting

  • CHU de Nançy

    Nancy

    Adeline GERMAIN, germain.adeline@gmail.com

    Not yet recruiting

  • CHU de Nantes

    Nantes

    Emilie DUCHALAIS-DASSONNEVILLE, emilie.dassonneville@chu-nantes.fr

    Not yet recruiting

  • Ap-HP Hopital St Louis

    Paris

    Léon MAGGIORI, leon.maggiori@aphp.fr

    Not yet recruiting

  • AP-HP Hôpital Européen Georges Pompidou

    Paris

    Gilles MANCEAU

    Not yet recruiting

  • AP-HP Le Kremlin-Bicetre

    Paris

    Stéphane BENOIST, stephane.benoist@aphp.fr

    Not yet recruiting

  • AP-HP St Antoine

    Paris

    Jérémie LEFEVRE, jeremie.lefevre@aphp.fr

    Not yet recruiting

  • CHU de Rennes

    Rennes

    Véronique DESFOURNEAUX, Veronique.desfourneaux@chu-rennes.fr

    Not yet recruiting

  • CHU de Strasbourg HautePierre

    Strasbourg

    Simone MANFREDELLI, simone.manfredelli@chru-strasbourg.fr

    Not yet recruiting

  • CHU de Toulouse

    Toulouse

    Etienne BOUSCAIL, ebuscail@me.com

    Not yet recruiting

Other trials in France

About this study

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.

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.

Conditions
Crohn Disease
Being tested
Kono-S anastomosis, Conventional anastomosis for ileocolonicresection of Crohn's disease
Keywords
Crohn's disease, Kono-S anastomosis, conventional anastomosis, endoscopic recurrence
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kono-S anastomosisProcedure or surgery

    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 diseaseProcedure or surgery

    conventional anastomosis for ileocolonicresection of Crohn's disease

Study groups in NCT05974358
Study groupRoleWhat they receive
Kono-S groupExperimentalKono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.
Receives: Procedure: Kono-S anastomosis
Control groupOtherConventional side-to-side ileocolonic anastomosis
Receives: Procedure: Conventional anastomosis for ileocolonicresection of Crohn's disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Month 6

Secondary outcomes (10)

  1. 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

    Measured: Month 6

  2. 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

    Measured: Month 12

  3. 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

    Measured: Month 18

  4. 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

    Measured: Month 24

  5. 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).

    Measured: Month 6

  6. 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).

    Measured: Month12

  7. 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).

    Measured: Month18

  8. 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).

    Measured: Month24

  9. Fecal calprotectin

    Fecal calprotectin

    Measured: Month 6

  10. Fecal calprotectin

    Fecal calprotectin

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study startMar 2025 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, multicenter,randomized study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05974358
Sponsor's protocol ID
2023/802
Acronym
KOALA
Status last verified
Feb 2025
First submitted
26 Jul 2023
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Kono-S anastomosis and Conventional anastomosis for ileocolonicresection of Crohn's disease in people with Crohn Disease, run by Centre Hospitalier Universitaire de Besancon at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zaher LAKKIS (+33381218988, zlakkis@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

endoscopy score (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05974358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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KOALA Clinical Trial NCT05974358 | AzTrials