<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/NCT03008265</url>
  </required_header>
  <id_info>
    <org_study_id>2016-Fascial-dehiscence-mort</org_study_id>
    <nct_id>NCT03008265</nct_id>
  </id_info>
  <brief_title>Fascial Dehiscence and Mortality</brief_title>
  <official_title>Just a Fascial Dehiscence? Nationwide Cohort Study on the Mortality Associated With Fascial Dehiscence After Colonic Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kristian Kiim Jensen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nationwide cohort study on short- and long-term mortality of patients with and without&#xD;
      postoperative fascial dehiscence.&#xD;
&#xD;
      The cohort will be comprised of patient undergoing open colonic resection for colonic cancer&#xD;
      registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence&#xD;
      and the outcome of interest 30-day, 3- and 5-year mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">March 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>3-year mortality</measure>
    <time_frame>Three years postoperatively</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">9000</enrollment>
  <condition>Postoperative Wound Breakdown</condition>
  <arm_group>
    <arm_group_label>Colonic cancer resection</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postoperative fascial dehiscence</intervention_name>
    <arm_group_label>Colonic cancer resection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent open colonic resection for carcinoma in the period 2001-2008 in&#xD;
        Denmark.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who underwent open colonic resection identified in the DCCG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristian K Jensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Digestive Disease Center, Bispebjerg Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Digestive Disease Center, Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen NV</city>
        <state>Copenhagen</state>
        <zip>DK-2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Kristian Kiim Jensen</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Fascial dehiscence</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Dehiscence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03008265
org study id: 2016-Fascial-dehiscence-mort
nct id: NCT03008265
lead sponsor: 
has dmc: Yes
Nationwide cohort study on short- and long-term mortality of patients with and without
      postoperative fascial dehiscence.

      The cohort will be comprised of patient undergoing open colonic resection for colonic cancer
      registered in the Danish Colorectal Cancer Group Database. The exposure is fascial dehiscence
      and the outcome of interest 30-day, 3- and 5-year mortality.
observational model: Cohort
time perspective: Retrospective
measure: 3-year mortality
time frame: Three years postoperatively
arm group label: Colonic cancer resection
intervention type: Other
intervention name: Postoperative fascial dehiscence
arm group label: Colonic cancer resection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kristian K Jensen, MD
role: Principal Investigator
affiliation: Digestive Disease Center, Bispebjerg Hospital
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Kristian Kiim Jensen
investigator title: Dr.
mesh term: Surgical Wound Dehiscence
sharing ipd: Undecided