<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/NCT02263625</url>
  </required_header>
  <id_info>
    <org_study_id>DK_03</org_study_id>
    <nct_id>NCT02263625</nct_id>
  </id_info>
  <brief_title>Regional Differences In Indication for Ventral Hernia Repair</brief_title>
  <official_title>Regional Differences In Indication for Ventral Hernia Repair</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 aim of the present study is to investigate whether there are differences in indication&#xD;
      for ventral hernia repair and surgical approach among hernia surgeons from different&#xD;
      geographical regions of Denmark.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 outpatient consultation will be taped and distributed among hernia surgeons in different&#xD;
      regions of Denmark. The surgeon will then be asked to answer a questionnaire regarding the&#xD;
      treatment and surgical technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in indication for ventral hernia repair</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients offered a ventral hernia repair after primary consultation by different hernia specialists.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in choice of surgical technique between surgeons</measure>
    <time_frame>6 months</time_frame>
    <description>Which surgical approach does different surgeons offer patients with a ventral hernia</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Ventral Hernia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to Køge Hospital Surg. Department with ventral hernia in December 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred to Køge Hospital Surg. Department with ventral hernia in December&#xD;
             2014&#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>Indication</keyword>
  <keyword>Differences</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</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/NCT02263625
org study id: DK_03
nct id: NCT02263625
lead sponsor: 
has dmc: No
The aim of the present study is to investigate whether there are differences in indication
      for ventral hernia repair and surgical approach among hernia surgeons from different
      geographical regions of Denmark.
30 outpatient consultation will be taped and distributed among hernia surgeons in different
      regions of Denmark. The surgeon will then be asked to answer a questionnaire regarding the
      treatment and surgical technique.
observational model: Cohort
time perspective: Prospective
measure: Differences in indication for ventral hernia repair
time frame: 6 months
description: Number of patients offered a ventral hernia repair after primary consultation by different hernia specialists.
measure: Differences in choice of surgical technique between surgeons
time frame: 6 months
description: Which surgical approach does different surgeons offer patients with a ventral hernia
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: Hernia, Ventral