<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/NCT01669837</url>
  </required_header>
  <id_info>
    <org_study_id>BM-IFA-06</org_study_id>
    <nct_id>NCT01669837</nct_id>
  </id_info>
  <brief_title>An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias</brief_title>
  <official_title>Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duomed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duomed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multicenter, observational registry to collect data of laparoscopic inguinal&#xD;
      hernia repair using surgical tissue glue fixation. The objective is to determine the&#xD;
      prevalence of chronic pain at 1 year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2012</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative complications</measure>
    <time_frame>1 day</time_frame>
    <description>Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>Up to 30 days after index-procedure</time_frame>
    <description>Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic intake</measure>
    <time_frame>Discharge, 5 weeks</time_frame>
    <description>Intake of analgesics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Preoperative, 5 weeks, 1 year</time_frame>
    <description>QOL assessed by EQ-5D questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from hernia-related reinterventions</measure>
    <time_frame>1 year</time_frame>
    <description>Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late complications</measure>
    <time_frame>1 year</time_frame>
    <description>Local numbness, groin discomfort, hernia recurrence, sexual dysfunction</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Patient group</arm_group_label>
    <description>Administration of surgical tissue glue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mesh fixation with surgical tissue glue</intervention_name>
    <description>Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation</description>
    <arm_group_label>Patient group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a primary inguinal hernia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is older than 18 years.&#xD;
&#xD;
          -  Written informed consent is obtained from patient.&#xD;
&#xD;
          -  Patient is able to complete the EQ-5D questionnaire.&#xD;
&#xD;
          -  Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation&#xD;
             is established with solely surgical tissue glue (Ifbond™).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a recurrent inguinal hernia.&#xD;
&#xD;
          -  Patient is treated using the Lichtenstein technique.&#xD;
&#xD;
          -  Mesh fixation with sutures, tacks, absorbable tacks or clips.&#xD;
&#xD;
          -  Patient is allergic to components of surgical tissue glue (Ifbond™).&#xD;
&#xD;
          -  Patient has a life expectancy of less than 1 year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kurt Van der Speeten, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ziekenhuis Oost-Limburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inguinal hernia</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Surgical tissue glue</keyword>
  <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/NCT01669837
org study id: BM-IFA-06
nct id: NCT01669837
lead sponsor: 
has dmc: No
Prospective, multicenter, observational registry to collect data of laparoscopic inguinal
      hernia repair using surgical tissue glue fixation. The objective is to determine the
      prevalence of chronic pain at 1 year.
observational model: Cohort
time perspective: Prospective
measure: Postoperative pain
time frame: up to 1 year
description: Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.
measure: Intraoperative complications
time frame: 1 day
description: Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.
measure: Postoperative complications
time frame: Up to 30 days after index-procedure
description: Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.
measure: Analgesic intake
time frame: Discharge, 5 weeks
description: Intake of analgesics.
measure: Quality of life (QOL)
time frame: Preoperative, 5 weeks, 1 year
description: QOL assessed by EQ-5D questionnaire.
measure: Freedom from hernia-related reinterventions
time frame: 1 year
description: Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.
measure: Late complications
time frame: 1 year
description: Local numbness, groin discomfort, hernia recurrence, sexual dysfunction
arm group label: Patient group
description: Administration of surgical tissue glue.
intervention type: Device
intervention name: Mesh fixation with surgical tissue glue
description: Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation
arm group label: Patient group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kurt Van der Speeten, MD
role: Principal Investigator
affiliation: Ziekenhuis Oost-Limburg
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Inguinal