<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/NCT02210416</url>
  </required_header>
  <id_info>
    <org_study_id>NKCH-Surg-011</org_study_id>
    <nct_id>NCT02210416</nct_id>
  </id_info>
  <brief_title>Costs of Complications in Inguinal Hernia Repair</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Karelia Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North Karelia Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of&#xD;
      short-term advantages compared to open hernioplasties with mesh. In the prevailing economic&#xD;
      climate, the total costs of treatment is a subject of intense research. This study is&#xD;
      designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a&#xD;
      special emphasis in costs of treatment, complications and convalescence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cost of complication</measure>
    <time_frame>3 years</time_frame>
    <description>any complication associated with hernia surgery within 3 years, and its total costs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cost of primary treatment</measure>
    <time_frame>2 months</time_frame>
    <description>the in-hospital costs of inguinal hernia repair surgery and the costs of convalescence following surgery</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">968</enrollment>
  <condition>Inguinal Hernia</condition>
  <condition>Complication</condition>
  <arm_group>
    <arm_group_label>LAP repair</arm_group_label>
    <description>patients receiving laparoscopic inguinal hernia repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open repair</arm_group_label>
    <description>patients receiving open flat mesh repair of inguinal hernia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>inguinal hernia surgery</intervention_name>
    <arm_group_label>LAP repair</arm_group_label>
    <arm_group_label>open repair</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing laparoscopic inguinal hernia repair (TAPP or TEP) during 2002-2011&#xD;
        A sample of 528 patients undergoing open flat mesh repair in 2002-2011.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients treated surgically for inguinal hernia between 2002-2011&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>North Karelia Central Hospital</name>
      <address>
        <city>Joensuu</city>
        <zip>FIN-80210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>October 11, 2015</last_update_submitted>
  <last_update_submitted_qc>October 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>North Karelia Central Hospital</investigator_affiliation>
    <investigator_full_name>Sanna Kouhia</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, Inguinal</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/NCT02210416
org study id: NKCH-Surg-011
nct id: NCT02210416
lead sponsor: 
has dmc: No
Laparoscopic inguinal hernia repair is becoming increasingly popular mainly because of
      short-term advantages compared to open hernioplasties with mesh. In the prevailing economic
      climate, the total costs of treatment is a subject of intense research. This study is
      designed to evaluate the results of open and laparoscopic inguinal hernia repairs, with a
      special emphasis in costs of treatment, complications and convalescence.
observational model: Case-Control
time perspective: Retrospective
measure: cost of complication
time frame: 3 years
description: any complication associated with hernia surgery within 3 years, and its total costs
measure: cost of primary treatment
time frame: 2 months
description: the in-hospital costs of inguinal hernia repair surgery and the costs of convalescence following surgery
arm group label: LAP repair
description: patients receiving laparoscopic inguinal hernia repair
arm group label: open repair
description: patients receiving open flat mesh repair of inguinal hernia
intervention type: Procedure
intervention name: inguinal hernia surgery
arm group label: LAP repair
arm group label: open repair
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: North Karelia Central Hospital
investigator full name: Sanna Kouhia
investigator title: MD
mesh term: Hernia
mesh term: Hernia, Inguinal