<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/NCT03792243</url>
  </required_header>
  <id_info>
    <org_study_id>Parastomalhernia 2019</org_study_id>
    <nct_id>NCT03792243</nct_id>
  </id_info>
  <brief_title>Outcomes After Parastomal Hernia Repair</brief_title>
  <official_title>Outcomes After Parastomal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Hernia Database</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the current study is to evaluate the overall outcomes after parastomal hernia&#xD;
      repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish&#xD;
      Patients Registry. Specifically, the readmission and reoperation rates will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Danish Hernia Database covers about 80% of all ventral hernia repairs performed in&#xD;
      Denmark. Data on size of hernia, type of surgery, type of mesh and fixation method is&#xD;
      available from the Danish Hernia Database. All healthcare services in Denmark are registered&#xD;
      in the Danish National Patients Registry and data on 30-day readmission rate, readmission&#xD;
      diagnosis and reoperation is found here. Each Danish citizen has a unique personal&#xD;
      identification number and by merging data from the Danish Hernia Database and National&#xD;
      Patients Registry, nationwide data on parastomal hernia repairs is available. The aim of the&#xD;
      current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark&#xD;
      from 2007-2017 focusing on readmission and reoperation rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 2022</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>30 days</time_frame>
    <description>Number of patients re-operated for a complication after a parastomal hernia repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>90 days</time_frame>
    <description>Number of patients readmitted after parastomal hernia repair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence</measure>
    <time_frame>10 years</time_frame>
    <description>Number of patients operated for recurrence after a parastomal hernia repair</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1062</enrollment>
  <condition>Parastomal Hernia</condition>
  <arm_group>
    <arm_group_label>Parastomal hernia</arm_group_label>
    <description>Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Complication</intervention_name>
    <description>Readmission, reoperation</description>
    <arm_group_label>Parastomal hernia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing parastomal hernia repair in Denmark from 2007-2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing parastomal hernia repair in Denmark from 2007-2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If data is not fully registered in the Danish Hernia Database&#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>Nadia Henriksen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zealand University Hospital, Koege, Dept. of Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept. of surgery, 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>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</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 14, 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, DMSc, Ass prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03792243
org study id: Parastomalhernia 2019
nct id: NCT03792243
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the current study is to evaluate the overall outcomes after parastomal hernia
      repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish
      Patients Registry. Specifically, the readmission and reoperation rates will be evaluated.
The Danish Hernia Database covers about 80% of all ventral hernia repairs performed in
      Denmark. Data on size of hernia, type of surgery, type of mesh and fixation method is
      available from the Danish Hernia Database. All healthcare services in Denmark are registered
      in the Danish National Patients Registry and data on 30-day readmission rate, readmission
      diagnosis and reoperation is found here. Each Danish citizen has a unique personal
      identification number and by merging data from the Danish Hernia Database and National
      Patients Registry, nationwide data on parastomal hernia repairs is available. The aim of the
      current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark
      from 2007-2017 focusing on readmission and reoperation rates.
observational model: Cohort
time perspective: Retrospective
measure: Reoperation
time frame: 30 days
description: Number of patients re-operated for a complication after a parastomal hernia repair
measure: Readmission
time frame: 90 days
description: Number of patients readmitted after parastomal hernia repair
measure: Recurrence
time frame: 10 years
description: Number of patients operated for recurrence after a parastomal hernia repair
arm group label: Parastomal hernia
description: Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017
intervention type: Procedure
intervention name: Complication
description: Readmission, reoperation
arm group label: Parastomal 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: Nadia Henriksen
role: Principal Investigator
affiliation: Zealand University Hospital, Koege, Dept. of Surgery
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Frederik Helgstrand
investigator title: MD, DMSc, Ass prof
mesh term: Hernia
sharing ipd: No