<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/NCT01699971</url>
  </required_header>
  <id_info>
    <org_study_id>2006/672-31/4</org_study_id>
    <nct_id>NCT01699971</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair</brief_title>
  <official_title>Randomized Controlled Study Comparing Three Different Techniques for Open</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain&#xD;
      postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life,&#xD;
      recovery from surgery and frequency of recurrencies in the three groups&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2009</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperatively pain</measure>
    <time_frame>Postoperative 36 month</time_frame>
    <description>Visual analog scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>36 month postoperative</time_frame>
    <description>SF36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of recurrencies</measure>
    <time_frame>postopertive 36 month</time_frame>
    <description>check patients journal</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Lichtenstein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hernia repair with lichtenstein propylene mesh</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hernia repair</intervention_name>
    <description>Hernia repair admodum Lichtenstein with polypropylene mesh</description>
    <arm_group_label>Lichtenstein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hernia repair</intervention_name>
    <description>Hernia repair with Ultra Pro Hernia System (UHS)</description>
    <arm_group_label>Lichtenstein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hernia repair</intervention_name>
    <description>Hernia repair with Prolene Hernia System(PHS)</description>
    <arm_group_label>Lichtenstein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-75 years&#xD;
&#xD;
          -  unilateral primary hernia&#xD;
&#xD;
          -  open surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrent Hernia&#xD;
&#xD;
          -  Bilateral Hernia&#xD;
&#xD;
          -  laparoscopic surgery&#xD;
&#xD;
          -  Female&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Thorell, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ersta Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>116 91</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Anders Thorell</investigator_full_name>
    <investigator_title>Assoc prof</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/NCT01699971
org study id: 2006/672-31/4
nct id: NCT01699971
lead sponsor: 
has dmc: No
The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain
      postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life,
      recovery from surgery and frequency of recurrencies in the three groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: postoperatively pain
time frame: Postoperative 36 month
description: Visual analog scale (VAS)
measure: Quality of life
time frame: 36 month postoperative
description: SF36
measure: frequency of recurrencies
time frame: postopertive 36 month
description: check patients journal
arm group label: Lichtenstein
arm group type: Active Comparator
description: Hernia repair with lichtenstein propylene mesh
intervention type: Procedure
intervention name: Hernia repair
description: Hernia repair admodum Lichtenstein with polypropylene mesh
arm group label: Lichtenstein
intervention type: Procedure
intervention name: Hernia repair
description: Hernia repair with Ultra Pro Hernia System (UHS)
arm group label: Lichtenstein
intervention type: Procedure
intervention name: Hernia repair
description: Hernia repair with Prolene Hernia System(PHS)
arm group label: Lichtenstein
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Anders Thorell, Assoc Prof
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Anders Thorell
investigator title: Assoc prof
mesh term: Hernia
mesh term: Hernia, Inguinal