<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/NCT02263599</url>
  </required_header>
  <id_info>
    <org_study_id>DK_01</org_study_id>
    <nct_id>NCT02263599</nct_id>
  </id_info>
  <brief_title>Conservative Treatment For Ventral Hernia</brief_title>
  <official_title>Conservative Treatment For Ventral Hernia</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 this study is to evaluate on which indication patients are offered operative&#xD;
      treatment for their ventral hernia, and to investigate the natural course of ventral hernia&#xD;
      in the population of patients not offered operation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">February 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>Percentage of conservatively treated ventral hernias that undergo surgery</measure>
    <time_frame>5 years</time_frame>
    <description>Percentage of conservatively treated ventral hernias at the primary surgical consultation, that undergoes surgery (acute or elective) later on</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient with ventral hernia that are treated conservatively</measure>
    <time_frame>5 years</time_frame>
    <description>Percentage of patient referred to Køge Surgical Department with ventral hernia that are treated conservatively instead of surgically</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2089</enrollment>
  <condition>Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>Conservatively treated ventral hernias</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgically treated ventral hernias</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients referred to the Surgical Department of Køge University Hospital in the&#xD;
        timeperiod from 2009 - 2014 with the diagnosis ventral hernia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients (older than 18 years) referred to the Surgical Department of Køge University&#xD;
        Hospital from 2009 - 2014 with the diagnosis ventral hernia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dunja Kokotovic, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Surgery, Køge Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of Surgery, Køge University Hospital</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2023</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>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</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>
  <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/NCT02263599
org study id: DK_01
nct id: NCT02263599
lead sponsor: 
has dmc: No
The aim of this study is to evaluate on which indication patients are offered operative
      treatment for their ventral hernia, and to investigate the natural course of ventral hernia
      in the population of patients not offered operation.
observational model: Cohort
time perspective: Prospective
measure: Percentage of conservatively treated ventral hernias that undergo surgery
time frame: 5 years
description: Percentage of conservatively treated ventral hernias at the primary surgical consultation, that undergoes surgery (acute or elective) later on
measure: Percentage of patient with ventral hernia that are treated conservatively
time frame: 5 years
description: Percentage of patient referred to Køge Surgical Department with ventral hernia that are treated conservatively instead of surgically
arm group label: Conservatively treated ventral hernias
arm group label: Surgically treated ventral hernias
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Dunja Kokotovic, MS
role: Principal Investigator
affiliation: Dept. of Surgery, Køge 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