<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/NCT03833856</url>
  </required_header>
  <id_info>
    <org_study_id>KNUH2019</org_study_id>
    <nct_id>NCT03833856</nct_id>
  </id_info>
  <brief_title>Incidence and Clinical Course of Colonoscopy Related Perforation</brief_title>
  <official_title>Incidence and Risk of Poor Outcomes After Colonoscopy Related Perforation: Result From a Prospective Data Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 aims to investigate the incidence and clinical course of colonoscopy related&#xD;
      perforation based on the result of a prospective registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In each endoscopy unit from participating hospital, there is a alarm system focusing on the&#xD;
      development of perforation. Therefore, perforation cases will not be missed from the&#xD;
      registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 2021</completion_date>
  <primary_completion_date type="Actual">August 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Operation</measure>
    <time_frame>1 month</time_frame>
    <description>Number of participants who take surgical treatment after perforation</description>
  </primary_outcome>
  <enrollment type="Actual">58</enrollment>
  <condition>Perforation Colon</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colonoscopy perforation</intervention_name>
    <description>The development of perforation after colonoscopy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patients undergoing colonoscopy who end up with perforation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have a perforation after colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to be registered.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eun Soo Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Eun Soo Kim, MD, PhD</investigator_full_name>
    <investigator_title>Professor</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/NCT03833856
org study id: KNUH2019
nct id: NCT03833856
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the incidence and clinical course of colonoscopy related
      perforation based on the result of a prospective registry.
In each endoscopy unit from participating hospital, there is a alarm system focusing on the
      development of perforation. Therefore, perforation cases will not be missed from the
      registry.
observational model: Case-Only
time perspective: Prospective
measure: Operation
time frame: 1 month
description: Number of participants who take surgical treatment after perforation
intervention type: Procedure
intervention name: colonoscopy perforation
description: The development of perforation after colonoscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eun Soo Kim, MD
role: Principal Investigator
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Eun Soo Kim, MD, PhD
investigator title: Professor
sharing ipd: No