<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/NCT03796169</url>
  </required_header>
  <id_info>
    <org_study_id>XC15FIMI0020K</org_study_id>
    <nct_id>NCT03796169</nct_id>
  </id_info>
  <brief_title>Effect of Intervention for Colonoscopy Quality is Associated With the Personal Characteristics</brief_title>
  <official_title>Effect of Intervention for Improving Colonoscopy Quality is Associated With the Personal Characteristics of the Endoscopist</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Saint Vincent's Hospital, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uijeongbu St. Mary Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul St. Mary's Hospital</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>
      This study aims to investigate whether the personal characteristics of the endoscopist is&#xD;
      associated with effect of interventions for colonoscopy quality improvement.&#xD;
&#xD;
      This is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators&#xD;
      including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per&#xD;
      colonoscopy of each endoscopist were measured in the health promotion centers of academic&#xD;
      hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3&#xD;
      months after each interventions (personal notification of quality indicators, open&#xD;
      notification of quality indicators, and colonoscopy quality education by a GI faculty. At the&#xD;
      end of the study, personal characteristics of each endoscopist was evaluated using fear of&#xD;
      negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Suboptimal colonoscopy quality is associated with development of interval colorectal cancer&#xD;
      and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality&#xD;
      effectively. The quality of screening colonoscopy for colorectal cancer depends on the&#xD;
      endoscopist who performed the examination. The aim of this study was to investigate the&#xD;
      impact of endoscopists' personal characteristics on the quality of colonoscopy and&#xD;
      effectiveness of intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of overall adenoma detection rate</measure>
    <time_frame>9 months</time_frame>
    <description>Primary outcome measures include overall adenoma detection rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of adenoma detection rate after personal notification</measure>
    <time_frame>3 months after personal notification</time_frame>
    <description>Primary outcome measures include adenoma detection rate after personal notification</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of adenoma detection rate after open notification</measure>
    <time_frame>3 months after open notification</time_frame>
    <description>Primary outcome measures include adenoma detection rate after open notification</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of adenoma detection rate after education</measure>
    <time_frame>3 months after education</time_frame>
    <description>Primary outcome measures include adenoma detection rate after education</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of overall polyp detection rate</measure>
    <time_frame>9 months</time_frame>
    <description>Secondary outcome measures include overall polyp detection rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of overall withdrawal time</measure>
    <time_frame>9 months</time_frame>
    <description>Secondary outcome measures include overall withdrawal time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of overall adenomas per colonoscopy</measure>
    <time_frame>9 months</time_frame>
    <description>Secondary outcome measures include overall adenomas per colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of polyp detection rate after personal notification</measure>
    <time_frame>3 months after personal notification</time_frame>
    <description>Primary outcome measures include polyp detection rate after personal notification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of polyp detection rate after open notification</measure>
    <time_frame>3 months after open notification</time_frame>
    <description>Primary outcome measures include polyp detection rate after open notification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of polyp detection rate after education</measure>
    <time_frame>3 months after education</time_frame>
    <description>Primary outcome measures include polyp detection rate after education</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of withdrawal time after personal notification</measure>
    <time_frame>3 months after personal notification</time_frame>
    <description>Primary outcome measures include withdrawal time after personal notification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of withdrawal time after open notification</measure>
    <time_frame>3 months after open notification</time_frame>
    <description>Primary outcome measures include withdrawal time after open notification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of withdrawal time after education</measure>
    <time_frame>3 months after education</time_frame>
    <description>Primary outcome measures include withdrawal time after education</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of adenomas per colonoscopy after personal notification</measure>
    <time_frame>3 months after personal notification</time_frame>
    <description>Primary outcome measures include adenomas per colonoscopy after personal notification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of adenomas per colonoscopy after open notification</measure>
    <time_frame>3 months after open notification</time_frame>
    <description>Primary outcome measures include adenomas per colonoscopy after open notification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of adenomas per colonoscopy after education</measure>
    <time_frame>3 months after education</time_frame>
    <description>Primary outcome measures include adenoma detection rate after education</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Colonoscopy</condition>
  <condition>Human Characteristics</condition>
  <arm_group>
    <arm_group_label>Endoscopist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention for personal notification, open notification and colonoscopy quality education by a GI faculty</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personal notification</intervention_name>
    <description>Baseline quality indicators of each endoscopist were measured and those were notified individually.</description>
    <arm_group_label>Endoscopist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Open notification</intervention_name>
    <description>Quality indicators were measured for 3 months after 1st interventions and those were notified openly</description>
    <arm_group_label>Endoscopist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty</description>
    <arm_group_label>Endoscopist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Highly experienced board-certified gastroenterologists performed colonoscopies in&#xD;
             health screening endoscopy centers.&#xD;
&#xD;
          -  Endoscopists who sign the consent&#xD;
&#xD;
          -  Patients for quality indicators of endoscopists&#xD;
&#xD;
               -  routinely perform outpatient screening, surveillance and diagnostic colonoscopy&#xD;
                  (first-time screening colonoscopies performed and had no previous colonoscopy&#xD;
                  within 3 years).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  endoscopists who refuse to sign the consent&#xD;
&#xD;
          -  Patients for quality indicators of endoscopists&#xD;
&#xD;
               -  Known hereditary polyposis syndrome, Inflammatory bowel disease, those with&#xD;
                  surgically altered anatomy, undergone previous colonoscopy within 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo-In Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology; Seoul St. Mary's hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Gastroenterology; Seoul St. Mary's hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Coe SG, Crook JE, Diehl NN, Wallace MB. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol. 2013 Feb;108(2):219-26; quiz 227. doi: 10.1038/ajg.2012.417. Epub 2013 Jan 8.</citation>
    <PMID>23295274</PMID>
  </reference>
  <reference>
    <citation>Shaukat A, Oancea C, Bond JH, Church TR, Allen JI. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1335-40. doi: 10.1016/j.cgh.2009.07.027. Epub 2009 Aug 7.</citation>
    <PMID>19665583</PMID>
  </reference>
  <reference>
    <citation>Jover R, Zapater P, Bujanda L, Hernandez V, Cubiella J, Pellise M, Ponce M, Ono A, Lanas A, Seoane A, Marin-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernandez-Diez S, Peris A, Nicolas-Perez D, Murcia O, Castells A, Quintero E; COLONPREV Study Investigators. Endoscopist characteristics that influence the quality of colonoscopy. Endoscopy. 2016 Mar;48(3):241-7. doi: 10.1055/s-0042-100185. Epub 2016 Feb 4.</citation>
    <PMID>26845473</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Bo-In Lee</investigator_full_name>
    <investigator_title>Professor, MD, PhD</investigator_title>
  </responsible_party>
  <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/NCT03796169
org study id: XC15FIMI0020K
nct id: NCT03796169
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate whether the personal characteristics of the endoscopist is
      associated with effect of interventions for colonoscopy quality improvement.

      This is a prospective, 9-month, multicenter, single-blind study. Baseline quality indicators
      including adenoma detection rate, polyp detection rate, withdrawal time and adenomas per
      colonoscopy of each endoscopist were measured in the health promotion centers of academic
      hospitals for 3 months. Follow-up measurements of quality indicators were repeated every 3
      months after each interventions (personal notification of quality indicators, open
      notification of quality indicators, and colonoscopy quality education by a GI faculty. At the
      end of the study, personal characteristics of each endoscopist was evaluated using fear of
      negative evaluation scale, cognitive flexibility inventory, and almost perfect scale.
Suboptimal colonoscopy quality is associated with development of interval colorectal cancer
      and colorectal cancer-related death. It is uncertain how to improve colonoscopy quality
      effectively. The quality of screening colonoscopy for colorectal cancer depends on the
      endoscopist who performed the examination. The aim of this study was to investigate the
      impact of endoscopists' personal characteristics on the quality of colonoscopy and
      effectiveness of intervention.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Measurement of overall adenoma detection rate
time frame: 9 months
description: Primary outcome measures include overall adenoma detection rate.
measure: Measurement of adenoma detection rate after personal notification
time frame: 3 months after personal notification
description: Primary outcome measures include adenoma detection rate after personal notification
measure: Measurement of adenoma detection rate after open notification
time frame: 3 months after open notification
description: Primary outcome measures include adenoma detection rate after open notification
measure: Measurement of adenoma detection rate after education
time frame: 3 months after education
description: Primary outcome measures include adenoma detection rate after education
measure: Measurement of overall polyp detection rate
time frame: 9 months
description: Secondary outcome measures include overall polyp detection rate.
measure: Measurement of overall withdrawal time
time frame: 9 months
description: Secondary outcome measures include overall withdrawal time.
measure: Measurement of overall adenomas per colonoscopy
time frame: 9 months
description: Secondary outcome measures include overall adenomas per colonoscopy.
measure: Measurement of polyp detection rate after personal notification
time frame: 3 months after personal notification
description: Primary outcome measures include polyp detection rate after personal notification
measure: Measurement of polyp detection rate after open notification
time frame: 3 months after open notification
description: Primary outcome measures include polyp detection rate after open notification
measure: Measurement of polyp detection rate after education
time frame: 3 months after education
description: Primary outcome measures include polyp detection rate after education
measure: Measurement of withdrawal time after personal notification
time frame: 3 months after personal notification
description: Primary outcome measures include withdrawal time after personal notification
measure: Measurement of withdrawal time after open notification
time frame: 3 months after open notification
description: Primary outcome measures include withdrawal time after open notification
measure: Measurement of withdrawal time after education
time frame: 3 months after education
description: Primary outcome measures include withdrawal time after education
measure: Measurement of adenomas per colonoscopy after personal notification
time frame: 3 months after personal notification
description: Primary outcome measures include adenomas per colonoscopy after personal notification.
measure: Measurement of adenomas per colonoscopy after open notification
time frame: 3 months after open notification
description: Primary outcome measures include adenomas per colonoscopy after open notification
measure: Measurement of adenomas per colonoscopy after education
time frame: 3 months after education
description: Primary outcome measures include adenoma detection rate after education
arm group label: Endoscopist
arm group type: Experimental
description: Intervention for personal notification, open notification and colonoscopy quality education by a GI faculty
intervention type: Behavioral
intervention name: Personal notification
description: Baseline quality indicators of each endoscopist were measured and those were notified individually.
arm group label: Endoscopist
intervention type: Behavioral
intervention name: Open notification
description: Quality indicators were measured for 3 months after 1st interventions and those were notified openly
arm group label: Endoscopist
intervention type: Behavioral
intervention name: Education
description: Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty
arm group label: Endoscopist
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bo-In Lee, MD, PhD
role: Principal Investigator
affiliation: Division of Gastroenterology; Seoul St. Mary's hospital
facility: 
country: Korea, Republic of
citation: Coe SG, Crook JE, Diehl NN, Wallace MB. An endoscopic quality improvement program improves detection of colorectal adenomas. Am J Gastroenterol. 2013 Feb;108(2):219-26; quiz 227. doi: 10.1038/ajg.2012.417. Epub 2013 Jan 8.
PMID: 23295274
citation: Shaukat A, Oancea C, Bond JH, Church TR, Allen JI. Variation in detection of adenomas and polyps by colonoscopy and change over time with a performance improvement program. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1335-40. doi: 10.1016/j.cgh.2009.07.027. Epub 2009 Aug 7.
PMID: 19665583
citation: Jover R, Zapater P, Bujanda L, Hernandez V, Cubiella J, Pellise M, Ponce M, Ono A, Lanas A, Seoane A, Marin-Gabriel JC, Chaparro M, Cacho G, Herreros-de-Tejada A, Fernandez-Diez S, Peris A, Nicolas-Perez D, Murcia O, Castells A, Quintero E; COLONPREV Study Investigators. Endoscopist characteristics that influence the quality of colonoscopy. Endoscopy. 2016 Mar;48(3):241-7. doi: 10.1055/s-0042-100185. Epub 2016 Feb 4.
PMID: 26845473
responsible party type: Principal Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Bo-In Lee
investigator title: Professor, MD, PhD
sharing ipd: No