xml: <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/NCT06009484</url>
    </required_header>
    <id_info>
      <org_study_id>VTE-1</org_study_id>
      <nct_id>NCT06009484</nct_id>
    </id_info>
    <brief_title>VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program</brief_title>
    <official_title>Incidence of Venous Thrombotic Event After Curative Colon Cancer Surgery in an Enhanced Recovery After Surgery Program</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nordsjaellands Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bispebjerg Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Herlev and Gentofte Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hvidovre University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Nordsjaellands Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Based on data on a cohort of 2,141 patients undergoing elective colonic cancer resection in&#xD;
        an ERAS program, the incidence of postoperative thromboembolic events is estimated in&#xD;
        patients no receiving prolonged thromboembolic prophylaxis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Copenhagen cOmplete Mesocolic Excision Study (COMES) database contains comprehensive data&#xD;
        on preoperative, intraoperative, postoperative and tumor related variable on patients&#xD;
        undergoing elective colonic cancer resection at four public university clinics providing all&#xD;
        colorectal cancer treatment for the 1.8 million residents of the Capital Region of Denmark&#xD;
        during the period 2014-2017.&#xD;
  &#xD;
        None of these hospitals had implemented prolonged thromboembolic prophylaxis after discharge.&#xD;
  &#xD;
        The medical records were reviewed with focusing on VTE prophylaxis, ongoing preoperative and&#xD;
        postoperative anticoagulant treatment, the length of hospital stay (LOS), and readmission to&#xD;
        ensure high data validity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2014</start_date>
    <completion_date type="Actual">March 15, 2018</completion_date>
    <primary_completion_date type="Actual">December 31, 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>60 Days</target_duration>
    <primary_outcome>
      <measure>Postoperative venous thromboembolic event</measure>
      <time_frame>60 days</time_frame>
      <description>Deep venous thrombosis or pulmonary embolism</description>
    </primary_outcome>
    <enrollment type="Actual">2141</enrollment>
    <condition>Deep Vein Thrombosis, Pulmonary Embolus</condition>
    <condition>Colon Cancer</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Colon resection</intervention_name>
      <description>Colon cancer resection</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing elective macroradical resection for UICC Stage I-III colonic&#xD;
          adenocarcinoma in the Capital Region of Denmark between January 1, 2014, and December 31,&#xD;
          2017. The database does not include acute cases, cases of metachronous colorectal cancers&#xD;
          or rectal cancers without synchronous colonic adenocarcinoma.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  elective macroradical resection for UICC Stage I-III colonic adenocarcinoma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  concomitant rectum resection&#xD;
  &#xD;
            -  soly appendix carcinoma&#xD;
  &#xD;
            -  diagnosed with pulmonary embolism or deep venous thrombosis before primary discharge&#xD;
  &#xD;
            -  dying before discharge from the hospital or discharged at postoperative day 28 or&#xD;
               later&#xD;
  &#xD;
            -  treatment with vitamin K antagonists, heparin or new oral anticoagulants before or&#xD;
               after surgery&#xD;
  &#xD;
            -  VTE less than 3 months before the colon resection&#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>Claus A Bertelsen, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Copenhagen University Hospital - North Zealand</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prolonged thromboembolic prophylaxis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colonic Neoplasms</mesh_term>
      <mesh_term>Pulmonary Embolism</mesh_term>
      <mesh_term>Thrombosis</mesh_term>
      <mesh_term>Venous Thrombosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009484
  org study id: VTE-1
  nct id: NCT06009484
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Based on data on a cohort of 2,141 patients undergoing elective colonic cancer resection in
        an ERAS program, the incidence of postoperative thromboembolic events is estimated in
        patients no receiving prolonged thromboembolic prophylaxis.
  The Copenhagen cOmplete Mesocolic Excision Study (COMES) database contains comprehensive data
        on preoperative, intraoperative, postoperative and tumor related variable on patients
        undergoing elective colonic cancer resection at four public university clinics providing all
        colorectal cancer treatment for the 1.8 million residents of the Capital Region of Denmark
        during the period 2014-2017.
  
        None of these hospitals had implemented prolonged thromboembolic prophylaxis after discharge.
  
        The medical records were reviewed with focusing on VTE prophylaxis, ongoing preoperative and
        postoperative anticoagulant treatment, the length of hospital stay (LOS), and readmission to
        ensure high data validity.
  observational model: Cohort
  time perspective: Prospective
  measure: Postoperative venous thromboembolic event
  time frame: 60 days
  description: Deep venous thrombosis or pulmonary embolism
  intervention type: Procedure
  intervention name: Colon resection
  description: Colon cancer resection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Claus A Bertelsen, Ph.D.
  role: Study Chair
  affiliation: Copenhagen University Hospital - North Zealand
  responsible party type: Sponsor
  mesh term: Colonic Neoplasms
  mesh term: Pulmonary Embolism
  mesh term: Thrombosis
  mesh term: Venous Thrombosis
  sharing ipd: No