<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/NCT01665859</url>
  </required_header>
  <id_info>
    <org_study_id>FH09</org_study_id>
    <nct_id>NCT01665859</nct_id>
  </id_info>
  <brief_title>Risk Factors for Poor Outcome After Epigastric and Umbilical Hernia Repair</brief_title>
  <official_title>Nationwide Prospective Study of Surgical Risk Factors for Poor Outcome After Epigastric and Umbilical 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>
      Umbilical and epigastric hernia repairs are common and performed by numerous surgical&#xD;
      techniques. Considering that the hernia repairs in general are relatively small and simple&#xD;
      procedures there are disproportionate poor results.&#xD;
&#xD;
      The aim of present study is to determine surgical risk factors for readmission after&#xD;
      umbilical and epigastric hernia repair and to report risk factors for later reoperation for&#xD;
      recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database&#xD;
      are included in the study. The included patients will be followed in up to 4 years in order&#xD;
      to identify correlation between technical aspects of the hernia repair and postoperative&#xD;
      morbidity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">January 2011</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>readmission</measure>
    <time_frame>30 days</time_frame>
    <description>Riskfactors for readmission within 30 days after umbilical or epigastric hernia repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>reoperation for recurrence</measure>
    <time_frame>up to 4 years</time_frame>
    <description>Risk factors for recurrence repair after umbilical or epigastric hernia repair</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6783</enrollment>
  <condition>Umbilical Hernia</condition>
  <condition>Epigastric Hernia</condition>
  <arm_group>
    <arm_group_label>Danish Ventral 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 elective umbilical or epigastric hernia repairs registered in tha Danish National&#xD;
        Hernia Database from January 1st 2007 to December 31st 2010&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Umbilical or epigastric hernia repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederik Helgstrand, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>dept. surgery, Køge sygehus, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Køge 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>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</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>
  <keyword>readmission</keyword>
  <keyword>recurrence</keyword>
  <keyword>umbilical</keyword>
  <keyword>epigastric</keyword>
  <keyword>hernia</keyword>
  <keyword>outcome</keyword>
  <keyword>morbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia, Umbilical</mesh_term>
    <mesh_term>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/NCT01665859
org study id: FH09
nct id: NCT01665859
lead sponsor: 
has dmc: No
Umbilical and epigastric hernia repairs are common and performed by numerous surgical
      techniques. Considering that the hernia repairs in general are relatively small and simple
      procedures there are disproportionate poor results.

      The aim of present study is to determine surgical risk factors for readmission after
      umbilical and epigastric hernia repair and to report risk factors for later reoperation for
      recurrence.
All elective umbilical or epigastric hernias registered in the Danish Ventral Hernia Database
      are included in the study. The included patients will be followed in up to 4 years in order
      to identify correlation between technical aspects of the hernia repair and postoperative
      morbidity.
observational model: Cohort
time perspective: Prospective
measure: readmission
time frame: 30 days
description: Riskfactors for readmission within 30 days after umbilical or epigastric hernia repair
measure: reoperation for recurrence
time frame: up to 4 years
description: Risk factors for recurrence repair after umbilical or epigastric hernia repair
arm group label: Danish Ventral 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: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frederik Helgstrand, MD
role: Principal Investigator
affiliation: dept. surgery, Køge sygehus, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Frederik Helgstrand
investigator title: MD
mesh term: Hernia, Umbilical
mesh term: Hernia