xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974358</url>
    </required_header>
    <id_info>
      <org_study_id>2023/802</org_study_id>
      <nct_id>NCT05974358</nct_id>
    </id_info>
    <brief_title>KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease</brief_title>
    <acronym>KOALA</acronym>
    <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.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Besancon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Besancon</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) currently affecting one&#xD;
        person in a thousand in France. It can lead to numerous digestive complications such as&#xD;
        fistulas, abscesses or stenosis. Despite numerous therapeutic advances, the rate of patients&#xD;
        requiring surgery remains very high, with approximately 50% requiring at least one surgical&#xD;
        intervention at 10 years after disease diagnosis. However, surgical treatment is not&#xD;
        curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic&#xD;
        recurrence at 1 year. The ileocolonic anastomosis is the main site of postoperative&#xD;
        recurrence currently defined by a Rutgeerts score (≥i2) 6 months after surgery. In 2003, Kono&#xD;
        et al. described a new operative technique that could reduce the rate of post-operative&#xD;
        recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting&#xD;
        column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). The study showed&#xD;
        no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease&#xD;
        in surgical recurrence rate at 5 years (15% vs 0%). Recently, a randomized Italian monocenter&#xD;
        study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2%&#xD;
        versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. The&#xD;
        limitations of this study are its monocentric nature and the lack of centralization of the&#xD;
        endoscopic analysis to assess the primary endpoint. This surgical technique has been&#xD;
        performed in some centers for ileocolonic Crohn's surgery since 2020. Nevertheless, the level&#xD;
        of evidence remains too low to establish practice recommendations. The KOALA study will be&#xD;
        the first prospective, multicenter, randomized study comparing KONO-S anastomosis and&#xD;
        conventional anastomosis for ileocolonicresection of Crohn's disease, with blinded and&#xD;
        centralized evaluation of recurrence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">January 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>prospective, multicenter,randomized study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>endoscopy score</measure>
      <time_frame>Month 6</time_frame>
      <description>Rutgeerts endoscopy score ≥ i2 (&gt;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.&#xD;
  I0 no lesions&#xD;
  1 &lt;5 aphthous lesions in the neoterminal ileum&#xD;
  2 &gt;5 anastomotic lesions with passable stenosis (skip lesions); or lesions in the area of the anastomosis&#xD;
  3 diffuse ileitis&#xD;
  4 diffuse ileitis with deep ulcerations and/or Stenosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Harvey-Bradshaw Index (HBI)</measure>
      <time_frame>Month 6</time_frame>
      <description>Harvey-Bradshaw Index (HBI) Disease not active: &lt;4 ; Mild disease activity: HBI &gt;= 4 and &lt;= 8 ; Moderate disease activity: HBI &gt; 8 and &lt;= 12 ; Severe disease activity: HBI &gt; 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Harvey-Bradshaw Index (HBI)</measure>
      <time_frame>Month 12</time_frame>
      <description>Harvey-Bradshaw Index (HBI) Disease not active: &lt;4 ; Mild disease activity: HBI &gt;= 4 and &lt;= 8 ; Moderate disease activity: HBI &gt; 8 and &lt;= 12 ; Severe disease activity: HBI &gt; 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Harvey-Bradshaw Index (HBI)</measure>
      <time_frame>Month 18</time_frame>
      <description>Harvey-Bradshaw Index (HBI) Disease not active: &lt;4 ; Mild disease activity: HBI &gt;= 4 and &lt;= 8 ; Moderate disease activity: HBI &gt; 8 and &lt;= 12 ; Severe disease activity: HBI &gt; 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Harvey-Bradshaw Index (HBI)</measure>
      <time_frame>Month 24</time_frame>
      <description>Harvey-Bradshaw Index (HBI) Disease not active: &lt;4 ; Mild disease activity: HBI &gt;= 4 and &lt;= 8 ; Moderate disease activity: HBI &gt; 8 and &lt;= 12 ; Severe disease activity: HBI &gt; 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crohn's Disease Activity Index (CDAI) clinical scores</measure>
      <time_frame>Month 6</time_frame>
      <description>Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI &lt; 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (&gt;450).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crohn's Disease Activity Index (CDAI) clinical scores</measure>
      <time_frame>Month12</time_frame>
      <description>Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI &lt; 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (&gt;450).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crohn's Disease Activity Index (CDAI) clinical scores</measure>
      <time_frame>Month18</time_frame>
      <description>Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI &lt; 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (&gt;450).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Crohn's Disease Activity Index (CDAI) clinical scores</measure>
      <time_frame>Month24</time_frame>
      <description>Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI &lt; 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (&gt;450).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fecal calprotectin</measure>
      <time_frame>Month 6</time_frame>
      <description>Fecal calprotectin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fecal calprotectin</measure>
      <time_frame>Month 12</time_frame>
      <description>Fecal calprotectin</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">226</enrollment>
    <condition>Crohn Disease</condition>
    <arm_group>
      <arm_group_label>Kono-S group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Conventional side-to-side ileocolonic anastomosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Kono-S anastomosis</intervention_name>
      <description>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).</description>
      <arm_group_label>Kono-S group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conventional anastomosis for ileocolonicresection of Crohn's disease</intervention_name>
      <description>conventional anastomosis for ileocolonicresection of Crohn's disease</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patient ≥ 18 years and ≤75 years&#xD;
  &#xD;
            -  With Crohn's disease.&#xD;
  &#xD;
            -  Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease&#xD;
               or disease refractory to medical treatment.&#xD;
  &#xD;
            -  Affiliated to the French social security system.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous ileocolonic resection&#xD;
  &#xD;
            -  Contraindication to postoperative endoscopy.&#xD;
  &#xD;
            -  Anastomosis with a planned defunctioning protective stoma.&#xD;
  &#xD;
            -  Emergency surgery (peritonitis).&#xD;
  &#xD;
            -  Lack of consent to the study.&#xD;
  &#xD;
            -  Pregnant patients.&#xD;
  &#xD;
            -  Refusal to participate or inability to provide informed consent.&#xD;
  &#xD;
            -  Patient under legal protection (individuals under guardianship by court order)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zaher LAKKIS</last_name>
      <phone>+33381218988</phone>
      <email>zlakkis@chu-besancon.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Astrid POZET</last_name>
      <phone>+33381218988</phone>
      <email>apozet@chu-besancon.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHu de Besançon</name>
        <address>
          <city>Besançon</city>
          <zip>25030</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Zaher LAKKIS</last_name>
        <email>zlakkis@chu-besancon.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Crohn's disease</keyword>
    <keyword>Kono-S anastomosis</keyword>
    <keyword>conventional anastomosis</keyword>
    <keyword>endoscopic recurrence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974358
  org study id: 2023/802
  nct id: NCT05974358
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective, multicenter,randomized study
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: endoscopy score
  time frame: Month 6
  description: 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
  measure: Harvey-Bradshaw Index (HBI)
  time frame: Month 6
  description: 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
  measure: Harvey-Bradshaw Index (HBI)
  time frame: Month 12
  description: 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
  measure: Harvey-Bradshaw Index (HBI)
  time frame: Month 18
  description: 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
  measure: Harvey-Bradshaw Index (HBI)
  time frame: Month 24
  description: 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
  measure: Crohn's Disease Activity Index (CDAI) clinical scores
  time frame: Month 6
  description: 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).
  measure: Crohn's Disease Activity Index (CDAI) clinical scores
  time frame: Month12
  description: 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).
  measure: Crohn's Disease Activity Index (CDAI) clinical scores
  time frame: Month18
  description: 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).
  measure: Crohn's Disease Activity Index (CDAI) clinical scores
  time frame: Month24
  description: 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).
  measure: Fecal calprotectin
  time frame: Month 6
  description: Fecal calprotectin
  measure: Fecal calprotectin
  time frame: Month 12
  description: Fecal calprotectin
  arm group label: Kono-S group
  arm group type: Experimental
  description: Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al.
  arm group label: Control group
  arm group type: Other
  description: Conventional side-to-side ileocolonic anastomosis
  intervention type: Procedure
  intervention name: Kono-S anastomosis
  description: 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).
  arm group label: Kono-S group
  intervention type: Procedure
  intervention name: Conventional anastomosis for ileocolonicresection of Crohn's disease
  description: conventional anastomosis for ileocolonicresection of Crohn's disease
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zaher LAKKIS
  phone: +33381218988
  email: zlakkis@chu-besancon.fr
  last name: Astrid POZET
  phone: +33381218988
  email: apozet@chu-besancon.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Crohn Disease
  mesh term: Recurrence