<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/NCT03820570</url>
  </required_header>
  <id_info>
    <org_study_id>TEPP</org_study_id>
    <nct_id>NCT03820570</nct_id>
  </id_info>
  <brief_title>Comparison Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy</brief_title>
  <official_title>Comparison of Early and Long Term Outcomes of Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy for Primary Inguinal Hernias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uşak University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uşak University</source>
  <oversight_info>
    <has_dmc>No</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>
      comparison of early and long term results of open lichtenstein repair and totally&#xD;
      extraperitoneal herniorrhaphy for primary inguinal hernias.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early results such as postoperative pain, operation time and long term results such as&#xD;
      chronic pain and recurrence will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recurrence</measure>
    <time_frame>3 years</time_frame>
    <description>hernia recurrence</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>lichtenstein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hernia repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hernia repair</intervention_name>
    <description>inguinal hernia repair</description>
    <arm_group_label>lichtenstein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inguinal hernia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recurrent hernia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03820570
org study id: TEPP
nct id: NCT03820570
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
comparison of early and long term results of open lichtenstein repair and totally
      extraperitoneal herniorrhaphy for primary inguinal hernias.
Early results such as postoperative pain, operation time and long term results such as
      chronic pain and recurrence will be compared.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recurrence
time frame: 3 years
description: hernia recurrence
arm group label: lichtenstein
arm group type: Experimental
description: hernia repair
intervention type: Procedure
intervention name: hernia repair
description: inguinal hernia repair
arm group label: lichtenstein
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Inguinal