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

February 11, 2025 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
endoscopy score
Time Frame: 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
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fecal calprotectin
Time Frame: Month 6
Fecal calprotectin
Month 6
Fecal calprotectin
Time Frame: Month 12
Fecal calprotectin
Month 12
Harvey-Bradshaw Index (HBI)
Time Frame: Month 6
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
Harvey-Bradshaw Index (HBI)
Time Frame: Month 12
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
Harvey-Bradshaw Index (HBI)
Time Frame: Month 18
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
Harvey-Bradshaw Index (HBI)
Time Frame: 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
Month 24
Crohn's Disease Activity Index (CDAI) clinical scores
Time Frame: Month 6
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
Crohn's Disease Activity Index (CDAI) clinical scores
Time Frame: Month12
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
Crohn's Disease Activity Index (CDAI) clinical scores
Time Frame: Month18
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
Crohn's Disease Activity Index (CDAI) clinical scores
Time Frame: 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).
Month24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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