<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/NCT03256240</url>
  </required_header>
  <id_info>
    <org_study_id>1303013645</org_study_id>
    <nct_id>NCT03256240</nct_id>
  </id_info>
  <brief_title>Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis</brief_title>
  <official_title>Prospective Randomized Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis in the Prevention of Post-operative Recurrence of Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Crohn's and Colitis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</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>
      This study proposes a randomized prospective study comparing the Kono-S anastomosis to the&#xD;
      standard side-to-side anastomosis.This will be a multi-center randomized prospective trial.&#xD;
      Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized&#xD;
      to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Aim:&#xD;
&#xD;
        -  The primary aim of this study is to compare the postoperative recurrence of CD using the&#xD;
           Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and&#xD;
           side-to-side functional end anastomosis (Group2) and surgical recurrence rate at 60&#xD;
           months between the groups.&#xD;
&#xD;
        -  The secondary aim is to evaluate the postoperative recurrence of CD using the Rutgeerts&#xD;
           score at 12-18 and 60 months between the groups; time to surgical recurrence between&#xD;
           Group1 and Group2 measured in months from the index surgery, yearly Crohn's disease&#xD;
           surgical therapy impact using the Work Productivity and Activity Impairment (WPAI)&#xD;
           questionnaire; yearly Health-Related Quality of Life using the Short Inflammatory Bowel&#xD;
           Disease Questionnaire, to evaluate disease activity yearly using Harvey-Bradshaw Index&#xD;
           and monitor medication therapy, readmission rates, and mortality rates through the 60&#xD;
           months follow-up, and utilize Focus Groups from national and international study sites&#xD;
           to evaluate patient's perspectives on surgical treatment, patients' goals of surgical&#xD;
           treatment, and surgical treatment's personal and social impacts&#xD;
&#xD;
      Methods&#xD;
&#xD;
      Design: This will be a multi-center randomized prospective trial with 338 subjects. Patients&#xD;
      with Crohn's ileitis or Crohn's ileocolitis requiring initial resection will be randomized to&#xD;
      undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.&#xD;
&#xD;
      Patients will be randomized into two Groups:&#xD;
&#xD;
      Group 1: Kono-S anastomosis vs. Group 2: side-to-side functional end anastomosis.&#xD;
&#xD;
      The purpose of this study is to compare the postoperative recurrence of Crohn's disease&#xD;
      between the Kono-S procedure and the side-to-side functional end anastomosis and to evaluate&#xD;
      the surgical recurrence rate at 60 months between the groups.&#xD;
&#xD;
      In any intestine surgery, after the sick portion of the bowel is removed, the intestinal&#xD;
      tract is restored by reconnecting the healthy ends together. The new connecting line is&#xD;
      called anastomosis and could be created in a variety of ways by the surgeon. This study will&#xD;
      compare two different intestinal connections called Kono-S anastomosis and the traditional&#xD;
      side-to-side functional end anastomosis. Initial studies have demonstrated that the Kono-S&#xD;
      anastomosis has prevented endoscopic evidence of the post-operative recurrence of Crohn's&#xD;
      disease at greater rates than the traditional side-to-side functional end anastomosis.&#xD;
&#xD;
      Follow-up: Patients will be discharged on no prophylactic treatments, and they will be&#xD;
      followed post-operatively at 3 to 6, 12 to 18, and 60 months with a colonoscopy to assess for&#xD;
      endoscopic recurrence. The mucosa will be graded with the Rutgeerts score for postoperative&#xD;
      recurrence. All colonoscopies are part of the standard treatment. All patients will have also&#xD;
      standard 30 days, 3 to 6, 12 to 18, 24, 36, 48, and 60 months follow-ups by phone call,&#xD;
      through medical records, or during the postoperative clinic visit.&#xD;
&#xD;
      Follow-up Care: Patients with a Rutgeerts score at 3-to-6 months of:&#xD;
&#xD;
        -  0, 1, or 2a will be followed prospectively with or without introducing medical treatment&#xD;
           at the discretion of the gastroenterologist.&#xD;
&#xD;
        -  above &gt;2a will initiate medical therapy for Crohn's disease&#xD;
&#xD;
        -  Should the patient's symptoms warrant, medical treatment can be initiated at any time at&#xD;
           the discretion of the gastroenterologist. This is a standard of care&#xD;
&#xD;
        -  Colonoscopic images (still color photos acceptable) will be shown to a&#xD;
           gastroenterologist blinded to the goal of the study for determination of the Rutgeerts&#xD;
           score.&#xD;
&#xD;
        -  post-operative endoscopic recurrence of CD using the Rutgeerts score at 12-18 months and&#xD;
           60 months between the groups. An endoscopic Rutgeerts score of 2b or higher will be&#xD;
           considered a recurrence.&#xD;
&#xD;
        -  Time to surgical recurrence between Group1 and Group2 measured in months from the index&#xD;
           surgery&#xD;
&#xD;
        -  Work Productivity and Activity Impairment (WPAI) questionnaire (a 6-item questionnaire&#xD;
           that measures the amount of absenteeism and presenteeism due to health problems) will be&#xD;
           administered annually for up to 60 months&#xD;
&#xD;
        -  Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire&#xD;
           (SIBDQ) (a 10-item shortened version of the original IBDQ, measuring the quality of life&#xD;
           in four domains: bowel symptoms, emotional health, systemic systems, and social&#xD;
           function) will be administered annually for up to 60 months.&#xD;
&#xD;
        -  Harvey Bradshaw Index as a marker of clinical disease activity will be used. This will&#xD;
           be recorded before the procedure (baseline), at 3 to 6 and 12-18 months, 24, 36, 48, and&#xD;
           at 60 months post-procedure.&#xD;
&#xD;
        -  Other monitoring- monitor medication therapy, readmission rates, and mortality rates&#xD;
           annually through the 60 months of follow-up between the groups&#xD;
&#xD;
        -  Focus groups from national and international study sites to evaluate patients'&#xD;
           perspectives on surgical treatment, patients' goals of surgical treatment, and surgical&#xD;
           treatment's personal and social impacts. This is a qualitative evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 12, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</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>Participants will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative remission of Crohn's disease between 3 and 6 months after surgery</measure>
    <time_frame>3-6 months after surgery</time_frame>
    <description>Endoscopic remission with a Rutgeert score between 3 and 6 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. Endoscopic remission is defined as a Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with surgical recurrence at 60 months</measure>
    <time_frame>60 months after surgery</time_frame>
    <description>Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative remission of Crohn's disease between 12 and 18 months and at 60 months after surgery</measure>
    <time_frame>12-18 and 60 months after surgery</time_frame>
    <description>Endoscopic remission with a Rutgeerts score at 12 to 18 and 60 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. An endoscopic Rutgeerts score of 2b or higher will be considered a recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Productivity and Activity Impairment (WPAI) due to Crohn's disease</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Work Productivity and Activity Impairment (WPAI) is a validated 6-item questionnaire that measures the amount of absenteeism and presenteeism due to CD during and activity impairment the 7 days prior to administration. It consists of 6 questions with the following domains: 1) employment status; 2) hours missed due to CD; 3) hours missed due to other reasons; 4) hours actually worked; 5) the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and 6) the degree to which CD affected regular activities from 0 (no effect) to 10 maximum impairment ). All six question' domains will be reported and compared between the groups. Between the groups and within patients, changes will be evaluated. The mean score annual variability in each domain will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire for Crohn's disease(10 questions)</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Validated questionnaire to evaluate the quality of life in IBD patients. The short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item shortened version of the original IBDQ, which was 32 items. Measures quality of life as measured in four domains, bowel symptoms, emotional health, systemic systems, and social function. SIBDQ score ranges between 10 and 70 points. QUOL is considered to be slightly (60-70 points), moderately (45-60 points), or severely impaired (10-45 points). In our study, the cut-off for relevant impairment of QUOL &lt; 60 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical disease activity measured by Harvey Bradshaw Index</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Harvey Bradshaw Index is a marker of clinical disease activity. The following score grading system will be used to determine the clinical disease activity:&#xD;
Remission &lt; 5 Mild disease 5-7 Moderate disease 8-16 Severe disease &gt;16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to surgical recurrence between Group1 and Group2</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Time to surgical recurrence between Group1 and Group2 measured in months from the index surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Focus Group</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Patient Focus Groups from national and international study sites to evaluate patient's perspectives on surgical treatment, patients' goals of surgical treatment, and surgical treatment's personal and social impacts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication therapy type</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Medication therapy for Crohn's disease after the index surgery. We will monitor the type of medications patients receive after surgery. The following five types of medications will be recorded: Biologics, Immunosuppressants, Corticosteroids, Anti-Inflammatory, and Antibiotics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rates between Group1 and Group2</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Number of readmission due to Crohn's disease after the index surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Number of patient expired after the index surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">338</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>side-to-side functional end anastomosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>side-to-side functional end anastomosis creation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kono-S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>side-to-side functional end anastomosis</intervention_name>
    <description>type of anastomosis</description>
    <arm_group_label>side-to-side functional end anastomosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kono-S analstomosis</intervention_name>
    <description>antimesenteric anastomosis</description>
    <arm_group_label>Kono-S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with Crohn's ileitis or ileocolitis requiring initial surgical resection.&#xD;
&#xD;
          2. Age of 18 years and older, male and female&#xD;
&#xD;
          3. All Phenotypes of Crohn's diisease will be included: nonpenetrating (B1), stricturing&#xD;
             (B2), and penetrating (fistulating) (B3), according to the Vienna classification&#xD;
&#xD;
          4. The patients can be on any medications coming into surgery, including prior anti-&#xD;
             tumor necrosis factor(TNF) therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients under 18 years of age&#xD;
&#xD;
          2. Patients with recurrent Crohn's&#xD;
&#xD;
          3. Pregnant patients&#xD;
&#xD;
          4. Patients with more than one non-contiguous site of active disease, thus requiring&#xD;
             multiple resections or additional bowel sparing procedures at the time of surgery.&#xD;
&#xD;
          5. Patients with Crohn's disease extending to the cecum and ascending colon&#xD;
&#xD;
          6. Patients who will need preventive postoperative medical treatment&#xD;
&#xD;
          7. Patients that need change of surgical procedure as per the surgeon at the time of the&#xD;
             intraoperative abdominal evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabrizio Michelassi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Koianka Trencheva, Dr.PH,BSN,MS</last_name>
    <role>Study Director</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Koianka Trencheva, Dr.PH,BSN,MS</last_name>
    <phone>646-962-2342</phone>
    <email>kivanova@med.cornell.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koiana Ivanova Trencheva, BSN,M.S.</last_name>
      <phone>646-962-2342</phone>
      <email>kivanova@med.cornell.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University Clinics Gasthuisberg Herestraat</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle Terrasson</last_name>
      <phone>+32 16 34 08 37</phone>
      <email>isabelle.terrasson@uzleuven.be</email>
    </contact>
    <contact_backup>
      <last_name>Andre D' Hoore, MD</last_name>
      <phone>+32 16 34 08 37</phone>
      <email>andre.dhoore@uzleuven.be</email>
    </contact_backup>
    <investigator>
      <last_name>Andre D' Hoore, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Würzburg</name>
      <address>
        <city>Würzburg</city>
        <state>Wurzburg</state>
        <zip>D-97080</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sven Flemming, MD</last_name>
      <email>Flemming_S@ukw.de</email>
    </contact>
    <investigator>
      <last_name>Sven Flemming, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin Weixler, MD</last_name>
      <email>benjamin.weixler@charite.de</email>
    </contact>
    <contact_backup>
      <last_name>Swantje Malinka, MD</last_name>
      <email>swantje.malinka@charite.de</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Theresien Hospital and St. Hedwigs Clinic gGmbH</name>
      <address>
        <city>Mannheim</city>
        <zip>68165</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Kienle,, MD</last_name>
      <phone>0049621 / 424-4252,</phone>
      <email>p.kienle@theresienkrankenhaus.de</email>
    </contact>
    <contact_backup>
      <last_name>Kirsten Staiger</last_name>
      <phone>(0621) 424-5809</phone>
      <email>K.Staiger@theresienkrankenhaus.de</email>
    </contact_backup>
    <investigator>
      <last_name>Peter Kienle,, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Humanitas University Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Milan</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annalisa Maroli, PhD</last_name>
      <phone>39 02 82247776</phone>
      <email>annalisa.maroli@cancercenter.humanitas.it</email>
    </contact>
    <contact_backup>
      <last_name>Antonino Spinelli, MD</last_name>
      <phone>39 02 82247776</phone>
      <email>antonino.spinelli@hunimed.eu</email>
    </contact_backup>
    <investigator>
      <last_name>Antonino Spinelli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano Scaringi, MD</last_name>
      <email>stefano.scaringi@unifi.it</email>
    </contact>
    <investigator>
      <last_name>Stefano Scaringi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Policlinico University Hospital</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaetano Luglio, MD</last_name>
      <email>gaetano.luglio@unina.it</email>
    </contact>
    <contact_backup>
      <last_name>Francesca Tropeano</last_name>
      <email>fpt.tropeano@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.</citation>
    <PMID>21471760</PMID>
  </reference>
  <reference>
    <citation>Kono T, Fichera A. Kono-S anastomosis for Crohn's disease: narrative - a video vignette. Colorectal Dis. 2014 Oct;16(10):833. doi: 10.1111/codi.12722. No abstract available.</citation>
    <PMID>25040294</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's recurrence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03256240
org study id: 1303013645
nct id: NCT03256240
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study proposes a randomized prospective study comparing the Kono-S anastomosis to the
      standard side-to-side anastomosis.This will be a multi-center randomized prospective trial.
      Patients with Crohn's ileitis or Crohn's ileocolitis requiring resection will be randomized
      to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.
Study Aim:

        -  The primary aim of this study is to compare the postoperative recurrence of CD using the
           Rutgeerts score at 3-6 months between the novel Kono-S anastomosis (Group1) and
           side-to-side functional end anastomosis (Group2) and surgical recurrence rate at 60
           months between the groups.

        -  The secondary aim is to evaluate the postoperative recurrence of CD using the Rutgeerts
           score at 12-18 and 60 months between the groups; time to surgical recurrence between
           Group1 and Group2 measured in months from the index surgery, yearly Crohn's disease
           surgical therapy impact using the Work Productivity and Activity Impairment (WPAI)
           questionnaire; yearly Health-Related Quality of Life using the Short Inflammatory Bowel
           Disease Questionnaire, to evaluate disease activity yearly using Harvey-Bradshaw Index
           and monitor medication therapy, readmission rates, and mortality rates through the 60
           months follow-up, and utilize Focus Groups from national and international study sites
           to evaluate patient's perspectives on surgical treatment, patients' goals of surgical
           treatment, and surgical treatment's personal and social impacts

      Methods

      Design: This will be a multi-center randomized prospective trial with 338 subjects. Patients
      with Crohn's ileitis or Crohn's ileocolitis requiring initial resection will be randomized to
      undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.

      Patients will be randomized into two Groups:

      Group 1: Kono-S anastomosis vs. Group 2: side-to-side functional end anastomosis.

      The purpose of this study is to compare the postoperative recurrence of Crohn's disease
      between the Kono-S procedure and the side-to-side functional end anastomosis and to evaluate
      the surgical recurrence rate at 60 months between the groups.

      In any intestine surgery, after the sick portion of the bowel is removed, the intestinal
      tract is restored by reconnecting the healthy ends together. The new connecting line is
      called anastomosis and could be created in a variety of ways by the surgeon. This study will
      compare two different intestinal connections called Kono-S anastomosis and the traditional
      side-to-side functional end anastomosis. Initial studies have demonstrated that the Kono-S
      anastomosis has prevented endoscopic evidence of the post-operative recurrence of Crohn's
      disease at greater rates than the traditional side-to-side functional end anastomosis.

      Follow-up: Patients will be discharged on no prophylactic treatments, and they will be
      followed post-operatively at 3 to 6, 12 to 18, and 60 months with a colonoscopy to assess for
      endoscopic recurrence. The mucosa will be graded with the Rutgeerts score for postoperative
      recurrence. All colonoscopies are part of the standard treatment. All patients will have also
      standard 30 days, 3 to 6, 12 to 18, 24, 36, 48, and 60 months follow-ups by phone call,
      through medical records, or during the postoperative clinic visit.

      Follow-up Care: Patients with a Rutgeerts score at 3-to-6 months of:

        -  0, 1, or 2a will be followed prospectively with or without introducing medical treatment
           at the discretion of the gastroenterologist.

        -  above >2a will initiate medical therapy for Crohn's disease

        -  Should the patient's symptoms warrant, medical treatment can be initiated at any time at
           the discretion of the gastroenterologist. This is a standard of care

        -  Colonoscopic images (still color photos acceptable) will be shown to a
           gastroenterologist blinded to the goal of the study for determination of the Rutgeerts
           score.

        -  post-operative endoscopic recurrence of CD using the Rutgeerts score at 12-18 months and
           60 months between the groups. An endoscopic Rutgeerts score of 2b or higher will be
           considered a recurrence.

        -  Time to surgical recurrence between Group1 and Group2 measured in months from the index
           surgery

        -  Work Productivity and Activity Impairment (WPAI) questionnaire (a 6-item questionnaire
           that measures the amount of absenteeism and presenteeism due to health problems) will be
           administered annually for up to 60 months

        -  Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire
           (SIBDQ) (a 10-item shortened version of the original IBDQ, measuring the quality of life
           in four domains: bowel symptoms, emotional health, systemic systems, and social
           function) will be administered annually for up to 60 months.

        -  Harvey Bradshaw Index as a marker of clinical disease activity will be used. This will
           be recorded before the procedure (baseline), at 3 to 6 and 12-18 months, 24, 36, 48, and
           at 60 months post-procedure.

        -  Other monitoring- monitor medication therapy, readmission rates, and mortality rates
           annually through the 60 months of follow-up between the groups

        -  Focus groups from national and international study sites to evaluate patients'
           perspectives on surgical treatment, patients' goals of surgical treatment, and surgical
           treatment's personal and social impacts. This is a qualitative evaluation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to undergo either the Kono-S anastomosis or the side-to-side functional end anastomosis.
primary purpose: Prevention
masking: None (Open Label)
measure: Post-operative remission of Crohn's disease between 3 and 6 months after surgery
time frame: 3-6 months after surgery
description: Endoscopic remission with a Rutgeert score between 3 and 6 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. Endoscopic remission is defined as a Rutgeerts score of 0, 1, or 2a at 3-to-6 months post-procedure colonoscopy.
measure: Number of subjects with surgical recurrence at 60 months
time frame: 60 months after surgery
description: Number of anastomoses in need of surgical revision for Crohn's disease recurrence after the initial index surgery.
measure: Post-operative remission of Crohn's disease between 12 and 18 months and at 60 months after surgery
time frame: 12-18 and 60 months after surgery
description: Endoscopic remission with a Rutgeerts score at 12 to 18 and 60 months in order to determine if the Kono-S procedure is more likely to prevent post-operative recurrence of Crohn's disease compared with the side-to-side functional end anastomosis. An endoscopic Rutgeerts score of 2b or higher will be considered a recurrence.
measure: Work Productivity and Activity Impairment (WPAI) due to Crohn's disease
time frame: up to 60 months
description: Work Productivity and Activity Impairment (WPAI) is a validated 6-item questionnaire that measures the amount of absenteeism and presenteeism due to CD during and activity impairment the 7 days prior to administration. It consists of 6 questions with the following domains: 1) employment status; 2) hours missed due to CD; 3) hours missed due to other reasons; 4) hours actually worked; 5) the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and 6) the degree to which CD affected regular activities from 0 (no effect) to 10 maximum impairment ). All six question' domains will be reported and compared between the groups. Between the groups and within patients, changes will be evaluated. The mean score annual variability in each domain will be evaluated.
measure: Health-Related Quality of Life using the Short Inflammatory Bowel Disease Questionnaire for Crohn's disease(10 questions)
time frame: up to 60 months
description: Validated questionnaire to evaluate the quality of life in IBD patients. The short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item shortened version of the original IBDQ, which was 32 items. Measures quality of life as measured in four domains, bowel symptoms, emotional health, systemic systems, and social function. SIBDQ score ranges between 10 and 70 points. QUOL is considered to be slightly (60-70 points), moderately (45-60 points), or severely impaired (10-45 points). In our study, the cut-off for relevant impairment of QUOL < 60 points.
measure: Clinical disease activity measured by Harvey Bradshaw Index
time frame: up to 60 months
description: Harvey Bradshaw Index is a marker of clinical disease activity. The following score grading system will be used to determine the clinical disease activity:
Remission < 5 Mild disease 5-7 Moderate disease 8-16 Severe disease >16
measure: Time to surgical recurrence between Group1 and Group2
time frame: up to 60 months
description: Time to surgical recurrence between Group1 and Group2 measured in months from the index surgery
measure: Focus Group
time frame: up to 60 months
description: Patient Focus Groups from national and international study sites to evaluate patient's perspectives on surgical treatment, patients' goals of surgical treatment, and surgical treatment's personal and social impacts.
measure: Medication therapy type
time frame: up to 60 months
description: Medication therapy for Crohn's disease after the index surgery. We will monitor the type of medications patients receive after surgery. The following five types of medications will be recorded: Biologics, Immunosuppressants, Corticosteroids, Anti-Inflammatory, and Antibiotics.
measure: Readmission rates between Group1 and Group2
time frame: up to 60 months
description: Number of readmission due to Crohn's disease after the index surgery
measure: Mortality rate
time frame: up to 60 months
description: Number of patient expired after the index surgery
arm group label: side-to-side functional end anastomosis
arm group type: Active Comparator
description: side-to-side functional end anastomosis creation
arm group label: Kono-S
arm group type: Active Comparator
description: antimesenteric functional side-to-side handsewn anastomosis, known as the Kono-S anastomosis
intervention type: Other
intervention name: side-to-side functional end anastomosis
description: type of anastomosis
arm group label: side-to-side functional end anastomosis
intervention type: Other
intervention name: Kono-S analstomosis
description: antimesenteric anastomosis
arm group label: Kono-S
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Fabrizio Michelassi, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Koianka Trencheva, Dr.PH,BSN,MS
role: Study Director
affiliation: Weill Medical College of Cornell University
last name: Koianka Trencheva, Dr.PH,BSN,MS
phone: 646-962-2342
email: kivanova@med.cornell.edu
facility: 
status: Terminated
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status: Recruiting
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status: Terminated
country: Belgium
country: Finland
country: Germany
country: Italy
country: Spain
country: United States
citation: Kono T, Ashida T, Ebisawa Y, Chisato N, Okamoto K, Katsuno H, Maeda K, Fujiya M, Kohgo Y, Furukawa H. A new antimesenteric functional end-to-end handsewn anastomosis: surgical prevention of anastomotic recurrence in Crohn's disease. Dis Colon Rectum. 2011 May;54(5):586-92. doi: 10.1007/DCR.0b013e318208b90f.
PMID: 21471760
citation: Kono T, Fichera A. Kono-S anastomosis for Crohn's disease: narrative - a video vignette. Colorectal Dis. 2014 Oct;16(10):833. doi: 10.1111/codi.12722. No abstract available.
PMID: 25040294
responsible party type: Sponsor
mesh term: Crohn Disease