<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/NCT02263612</url>
  </required_header>
  <id_info>
    <org_study_id>DK_02</org_study_id>
    <nct_id>NCT02263612</nct_id>
  </id_info>
  <brief_title>Late Mesh Complications After 3258 Incisional Hernia Operations</brief_title>
  <official_title>Late Mesh Complications After 3258 Incisional Hernia Operations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of&#xD;
      present study is to use large-scale data from DHD to uncover risk factors for long-term (30&#xD;
      days postoperative and later) readmission, reoperation, death and reoperation for recurrence&#xD;
      after incisional hernia repair with use of a synthetic mesh.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All principal incisional hernias registered in the Danish Hernia Database are included in the&#xD;
      study. The included patients have been followed for more than 4 years in order to identify&#xD;
      correlation between technical aspects of the hernia repair and postoperative morbidity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Reoperation</measure>
    <time_frame>Up to 7 years</time_frame>
    <description>Riskfactors for reoperation (any procedure) more than 30 days after incisional hernia repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>Up to 7 years</time_frame>
    <description>Riskfactors for readmission later than 30 days after incisional hernia repair</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Death</measure>
    <time_frame>Up to 7 years</time_frame>
    <description>Riskfactors for death later than 30 days after incisional hernia repair</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3258</enrollment>
  <condition>Incisional Hernia</condition>
  <arm_group>
    <arm_group_label>Danish Hernia Database</arm_group_label>
    <description>Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All incisional hernia repairs registered in tha Danish National Hernia Database from&#xD;
        January 1st 2007 to December 31st 2010&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Incisional Hernia Repair&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dunja Kokotovic, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>dept. of surgery, Køge University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Køge Sygehus</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Frederik Helgstrand</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Incisional Hernia</keyword>
  <keyword>Complications</keyword>
  <keyword>Long-term</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</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/NCT02263612
org study id: DK_02
nct id: NCT02263612
lead sponsor: 
has dmc: No
The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of
      present study is to use large-scale data from DHD to uncover risk factors for long-term (30
      days postoperative and later) readmission, reoperation, death and reoperation for recurrence
      after incisional hernia repair with use of a synthetic mesh.
All principal incisional hernias registered in the Danish Hernia Database are included in the
      study. The included patients have been followed for more than 4 years in order to identify
      correlation between technical aspects of the hernia repair and postoperative morbidity.
observational model: Cohort
time perspective: Retrospective
measure: Reoperation
time frame: Up to 7 years
description: Riskfactors for reoperation (any procedure) more than 30 days after incisional hernia repair
measure: Readmission
time frame: Up to 7 years
description: Riskfactors for readmission later than 30 days after incisional hernia repair
measure: Death
time frame: Up to 7 years
description: Riskfactors for death later than 30 days after incisional hernia repair
arm group label: Danish Hernia Database
description: Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dunja Kokotovic, MS
role: Principal Investigator
affiliation: dept. of surgery, Køge University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Frederik Helgstrand
investigator title: MD
mesh term: Hernia
mesh term: Incisional Hernia