<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/NCT02197585</url>
  </required_header>
  <id_info>
    <org_study_id>UHU</org_study_id>
    <nct_id>NCT02197585</nct_id>
  </id_info>
  <brief_title>Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery</brief_title>
  <acronym>UHU</acronym>
  <official_title>Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital del Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital del Mar</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.&#xD;
&#xD;
      Hypothesis: Glue may induce less complications and chronic pain than suture&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</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>Chronic pain after two years</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Glue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesh fixation with glue</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mesh fixation with suture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inguinal mesh hernioplasty</intervention_name>
    <arm_group_label>Glue</arm_group_label>
    <arm_group_label>Suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients&#xD;
&#xD;
          -  Aged more than 18 years&#xD;
&#xD;
          -  Primary inguinal hernia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inguinoscrotal hernia&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JA Pereira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital del Mar</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital del Mar</investigator_affiliation>
    <investigator_full_name>José A. Pereira</investigator_full_name>
    <investigator_title>Medico Adjunto Cirugia General</investigator_title>
  </responsible_party>
  <keyword>Male patients</keyword>
  <keyword>Age &gt; 18 year</keyword>
  <keyword>Primary hernia</keyword>
  <keyword>glue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <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/NCT02197585
org study id: UHU
nct id: NCT02197585
lead sponsor: 
has dmc: Yes
To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.

      Hypothesis: Glue may induce less complications and chronic pain than suture
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Chronic pain after two years
time frame: 24 months
arm group label: Glue
arm group type: Experimental
description: Mesh fixation with glue
arm group label: Suture
arm group type: Active Comparator
description: Mesh fixation with suture
intervention type: Procedure
intervention name: Inguinal mesh hernioplasty
arm group label: Glue
arm group label: Suture
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JA Pereira, MD
role: Principal Investigator
affiliation: Hospital del Mar
responsible party type: Principal Investigator
investigator affiliation: Hospital del Mar
investigator full name: José A. Pereira
investigator title: Medico Adjunto Cirugia General
mesh term: Chronic Pain
mesh term: Hernia
mesh term: Hernia, Inguinal