<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/NCT02983474</url>
  </required_header>
  <id_info>
    <org_study_id>NH16-007</org_study_id>
    <nct_id>NCT02983474</nct_id>
  </id_info>
  <brief_title>Korea Surgical Quality Improvement Program</brief_title>
  <acronym>KSQIP</acronym>
  <official_title>Development of Cholecystectomy Complication Predictive Model for Developing the Surgical Quality Improvement Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Evidence-Based Healthcare Collaborating Agency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Evidence-Based Healthcare Collaborating Agency</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The member of National Evidence-based Healthcare Collaborating Agency and the planning&#xD;
      committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol&#xD;
      of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American&#xD;
      College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National&#xD;
      Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values,&#xD;
      operation finding, general occurrences, postoperative occurrences, and follow-up data to&#xD;
      develop post cholecystectomy complication risk model.&#xD;
&#xD;
      The 50 surgeons from 20 hospitals have decided to participated in the primary prospective&#xD;
      study to apply KSQIP to cholecystectomy. The investigators developed web-based database&#xD;
      system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill&#xD;
      out the case report form. Finally, the investigators will provide a risk-adjusted surgical&#xD;
      risk calculator and feedback system for reducing complication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Composite of bile leakage and iatrogenic duct injury</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Cholecystectomy</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cholecystectomy</intervention_name>
    <description>Laparoscopic surgery&#xD;
Reverse Trendelenburg position&#xD;
Skin incision and trocar insertion&#xD;
CO2 gas insufflation&#xD;
Intra-abdominal inspection and gallbladder exposure&#xD;
Gallbladder traction&#xD;
Calot triangle exposure&#xD;
Cystic artery and cystic duct isolation&#xD;
Gallbladder bed dissection&#xD;
Bleeding control&#xD;
Gallbladder extraction&#xD;
Trocar removal and wound closure&#xD;
Open surgery&#xD;
Supine position&#xD;
Skin incision&#xD;
Intra-abdominal inspection and gallbladder exposure&#xD;
5. Gallbladder traction 6. Calot triangle exposure 7. Cystic artery and cystic duct isolation 8. Gallbladder bed dissection 9. Gallbladder extraction 10. Bleeding control 11. Wound closure</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or&#xD;
        cholelithiasis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or&#xD;
             cholelithiasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 age&#xD;
&#xD;
          -  Who underwent other abdominal surgery simultaneously&#xD;
&#xD;
          -  Gallbladder Cancer, cholangiocarcinoma&#xD;
&#xD;
          -  Who did not agree with participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02983474
org study id: NH16-007
nct id: NCT02983474
lead sponsor: 
has dmc: Yes
The member of National Evidence-based Healthcare Collaborating Agency and the planning
      committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol
      of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American
      College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National
      Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values,
      operation finding, general occurrences, postoperative occurrences, and follow-up data to
      develop post cholecystectomy complication risk model.

      The 50 surgeons from 20 hospitals have decided to participated in the primary prospective
      study to apply KSQIP to cholecystectomy. The investigators developed web-based database
      system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill
      out the case report form. Finally, the investigators will provide a risk-adjusted surgical
      risk calculator and feedback system for reducing complication.
observational model: Cohort
time perspective: Prospective
measure: Composite of bile leakage and iatrogenic duct injury
time frame: 1 month
intervention type: Procedure
intervention name: cholecystectomy
description: Laparoscopic surgery
Reverse Trendelenburg position
Skin incision and trocar insertion
CO2 gas insufflation
Intra-abdominal inspection and gallbladder exposure
Gallbladder traction
Calot triangle exposure
Cystic artery and cystic duct isolation
Gallbladder bed dissection
Bleeding control
Gallbladder extraction
Trocar removal and wound closure
Open surgery
Supine position
Skin incision
Intra-abdominal inspection and gallbladder exposure
5. Gallbladder traction 6. Calot triangle exposure 7. Cystic artery and cystic duct isolation 8. Gallbladder bed dissection 9. Gallbladder extraction 10. Bleeding control 11. Wound closure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No