<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/NCT03009929</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00469</org_study_id>
    <nct_id>NCT03009929</nct_id>
  </id_info>
  <brief_title>Validation Study of ClassIntra®</brief_title>
  <acronym>ClassIntra®</acronym>
  <official_title>International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <brief_summary>
    <textblock>
      Whereas there are several validated systems for reporting postoperative complications, there&#xD;
      are only a few and not prospectively validated systems for reporting intraoperative&#xD;
      complications. The investigators developed a definition and CLASSification for Intraoperative&#xD;
      Complications CLASSIC within a Delphi study involving international interdisciplinary&#xD;
      experts. As both surgery and anaesthesia may be involved in complications in the&#xD;
      perioperative period, all patient-related intraoperative complications occurring between skin&#xD;
      incision and closure are considered in this reporting system. CLASSIC was updated to&#xD;
      ClassIntra® v1·0, by encompassing five severity grades to align with the validated&#xD;
      Clavien-Dindo Classification for grading postoperative complications.&#xD;
&#xD;
      The aim of this international multicentre observational cohort study is to assess the&#xD;
      validity and practicability of this newly derived and updated classification system&#xD;
      ClassIntra® in patient undergoing an in-hospital surgical procedure. Providing an easy&#xD;
      applicable and internationally validated classification system is a contribution to improve&#xD;
      quality of health care and patient safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 6, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>intraoperative complications according to ClassIntra®</measure>
    <time_frame>during surgery (intraoperatively)</time_frame>
    <description>All intraoperative complications are recorded and classified according to their severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>in-hospital postoperative complications</measure>
    <time_frame>From after surgery up to hospital discharge, timeframe up to 30 days</time_frame>
    <description>All postoperative complications observed during the hospital stay are recorded and classified according to their severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>From start to the end of the surgical procedure</time_frame>
    <description>Time from start to end of the surgical procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complexity of main surgical procedure</measure>
    <time_frame>Baseline</time_frame>
    <description>Complexity according to British United Provident Association (BUPA) classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in-hospital mortality</measure>
    <time_frame>From after surgery up to hospital discharge, timeframe up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>30 days postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">2500</enrollment>
  <condition>Patient Safety</condition>
  <condition>Intraoperative Complications</condition>
  <condition>Postoperative Complications</condition>
  <condition>Risk Management</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study</intervention_name>
    <description>No intervention, observational only</description>
    <other_name>No intervention, observational only</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All in-hospital patients (consecutive or random sample) undergoing surgery in the operating&#xD;
        room with anaesthesia involvement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All in-hospital patients (consecutive or random sample) undergoing surgery in the&#xD;
             operating room with anaesthesia involvement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outpatients (patients undergoing one-day-surgery) (with and without&#xD;
             anaesthesia-involvement)&#xD;
&#xD;
          -  Procedures without anaesthesia-involvement (in- or out-patient)&#xD;
&#xD;
          -  ASA risk classification (ASA) VI patients (brain-death organ-donor)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salome Dell-Kuster, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolinas Healthcare System</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Sydney Colorectal Clinic</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barmherzige Brüder Krankenhaus</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical School, Aristotle University Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity College Dublin at Tallaght</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Valle de Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hopsital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Childrens Hospital Basel</name>
      <address>
        <city>Basel</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Graubünden</name>
      <address>
        <city>Chur</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Lausanne</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bürgerspital Solothurn</name>
      <address>
        <city>Solothurn</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schulthess Clinique Zurich</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara University Medical School</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St. Thomas Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Germany</country>
  </removed_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Intraoperative Complications</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/NCT03009929
org study id: 2016-00469
nct id: NCT03009929
lead sponsor: 
Whereas there are several validated systems for reporting postoperative complications, there
      are only a few and not prospectively validated systems for reporting intraoperative
      complications. The investigators developed a definition and CLASSification for Intraoperative
      Complications CLASSIC within a Delphi study involving international interdisciplinary
      experts. As both surgery and anaesthesia may be involved in complications in the
      perioperative period, all patient-related intraoperative complications occurring between skin
      incision and closure are considered in this reporting system. CLASSIC was updated to
      ClassIntra® v1·0, by encompassing five severity grades to align with the validated
      Clavien-Dindo Classification for grading postoperative complications.

      The aim of this international multicentre observational cohort study is to assess the
      validity and practicability of this newly derived and updated classification system
      ClassIntra® in patient undergoing an in-hospital surgical procedure. Providing an easy
      applicable and internationally validated classification system is a contribution to improve
      quality of health care and patient safety.
observational model: Cohort
time perspective: Prospective
measure: intraoperative complications according to ClassIntra®
time frame: during surgery (intraoperatively)
description: All intraoperative complications are recorded and classified according to their severity
measure: in-hospital postoperative complications
time frame: From after surgery up to hospital discharge, timeframe up to 30 days
description: All postoperative complications observed during the hospital stay are recorded and classified according to their severity
measure: Duration of surgery
time frame: From start to the end of the surgical procedure
description: Time from start to end of the surgical procedure
measure: Complexity of main surgical procedure
time frame: Baseline
description: Complexity according to British United Provident Association (BUPA) classification
measure: in-hospital mortality
time frame: From after surgery up to hospital discharge, timeframe up to 30 days
measure: 30-day mortality
time frame: 30 days postoperatively
measure: Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians
time frame: Baseline
intervention type: Other
intervention name: Observational study
description: No intervention, observational only
other name: No intervention, observational only
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 110 Years
healthy volunteers: No
last name: Salome Dell-Kuster, MD MSc
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
facility: 
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country: Australia
country: Austria
country: Greece
country: Ireland
country: Italy
country: Netherlands
country: New Zealand
country: Spain
country: Switzerland
country: Turkey
country: United Kingdom
country: United States
country: France
country: Germany
responsible party type: Sponsor
mesh term: Postoperative Complications
mesh term: Intraoperative Complications