<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/NCT03268200</url>
  </required_header>
  <id_info>
    <org_study_id>reexamination</org_study_id>
    <nct_id>NCT03268200</nct_id>
  </id_info>
  <brief_title>The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy</brief_title>
  <official_title>The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to determine whether segmental re-examination of the each segment&#xD;
      (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate&#xD;
      (ADR) and to evaluate the time-effectiveness of this approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were&#xD;
      scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced&#xD;
      colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or&#xD;
      polyposis syndrome, or were unable to provide informed consent. In addition, if the quality&#xD;
      of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score &lt;2 in&#xD;
      any segment of the colon), or if the cecum could not be intubated during the colonoscopy,&#xD;
      patients were excluded.&#xD;
&#xD;
      A randomization list was generated with the randomization algorithm of random sorting, using&#xD;
      Excel program. Included patients were randomly assigned to one of the two groups: segmental&#xD;
      re-examination group, in which the each segment (right colon, mid-colon, and left colon) was&#xD;
      examined twice segmentally; or control group, in which the withdrawal time in the each&#xD;
      segment was about 2 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Per-patient adenoma detection rate (ADR) at each segment of colon</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>per-patient polyp detection rate</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withdrawal time</measure>
    <time_frame>1 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Adenoma</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each segment of colon (right colon, mid-colon, and left colon) was examined twice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>segmental reexamination</intervention_name>
    <description>segmental reexamination during colonoscopy</description>
    <arm_group_label>Case group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had advanced colonic cancer, prior resection of the proximal colon,&#xD;
             inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed&#xD;
             consent.&#xD;
&#xD;
          -  If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale&#xD;
             [BBPS] score &lt;2 in any segment of the colon), or if the cecum could not be intubated&#xD;
             during the colonoscopy, patients were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Incheon St. Mary's hospital, Catholic university of Korea</name>
      <address>
        <city>Incheon</city>
        <zip>403-720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Jeong-Seon Ji</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03268200
org study id: reexamination
nct id: NCT03268200
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to determine whether segmental re-examination of the each segment
      (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate
      (ADR) and to evaluate the time-effectiveness of this approach.
The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were
      scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced
      colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or
      polyposis syndrome, or were unable to provide informed consent. In addition, if the quality
      of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in
      any segment of the colon), or if the cecum could not be intubated during the colonoscopy,
      patients were excluded.

      A randomization list was generated with the randomization algorithm of random sorting, using
      Excel program. Included patients were randomly assigned to one of the two groups: segmental
      re-examination group, in which the each segment (right colon, mid-colon, and left colon) was
      examined twice segmentally; or control group, in which the withdrawal time in the each
      segment was about 2 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Adenoma detection rate
time frame: 7 days
measure: Per-patient adenoma detection rate (ADR) at each segment of colon
time frame: 7 days
measure: per-patient polyp detection rate
time frame: 7 days
measure: Withdrawal time
time frame: 1 days
arm group label: Case group
arm group type: Experimental
description: Each segment of colon (right colon, mid-colon, and left colon) was examined twice
arm group label: Control group
arm group type: No Intervention
description: Withdrawal time in the each segment of colon (right colon, mid-colon, and left colon) was about 2 minutes.
intervention type: Other
intervention name: segmental reexamination
description: segmental reexamination during colonoscopy
arm group label: Case group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Jeong-Seon Ji
investigator title: Professor
mesh term: Adenoma
sharing ipd: No