<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/NCT01719718</url>
  </required_header>
  <id_info>
    <org_study_id>2012/075</org_study_id>
    <nct_id>NCT01719718</nct_id>
  </id_info>
  <brief_title>The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair</brief_title>
  <acronym>CLOSURE</acronym>
  <official_title>The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter prospective randomized controlled trial comparing closure versus non-closure of&#xD;
      the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in&#xD;
      laparoscopic ventral hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroma formation after 4 weeks.</measure>
    <time_frame>4 weeks after surgery.</time_frame>
    <description>The seroma formation is checked by clinical evaluation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain, discomfort and esthetic evaluation after 4 weeks.</measure>
    <time_frame>4 weeks after surgery.</time_frame>
    <description>Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain, discomfort and esthetic evaluation after 1 year.</measure>
    <time_frame>1 year after surgery.</time_frame>
    <description>Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain, discomfort and esthetic evaluation after 2 years.</measure>
    <time_frame>2 years after surgery.</time_frame>
    <description>Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>Closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Closure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Closure of hernia defect.</intervention_name>
    <description>Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).</description>
    <arm_group_label>Closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No closure of the hernia defect.</intervention_name>
    <description>Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).</description>
    <arm_group_label>Non-Closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent from the patient or his/her legal representative&#xD;
&#xD;
          -  Ventral or incisional hernia requiring elective surgical repair&#xD;
&#xD;
          -  Diameter between 2 and 5cm in width&#xD;
&#xD;
          -  Midline and flank hernias are eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No written informed consent&#xD;
&#xD;
          -  'Hostile' abdomen, open abdomen treatment&#xD;
&#xD;
          -  Contraindication to pneumoperitoneum&#xD;
&#xD;
          -  Emergency surgery (incarcerated hernia)&#xD;
&#xD;
          -  Parastomal hernia&#xD;
&#xD;
          -  Subxiphoidal hernia&#xD;
&#xD;
          -  Subcostal hernia&#xD;
&#xD;
          -  Suprapubic hernia&#xD;
&#xD;
          -  Clean-contaminated or contaminated field&#xD;
&#xD;
          -  Hernia diameter &gt;5cm in width&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Non-compliance&#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>Frederik Berrevoet, MD, PhD, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algemeen Stedelijk Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imelda Hospital</name>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincentius Hospital</name>
      <address>
        <city>Deinze</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maria Middelares</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Mont Godinne</name>
      <address>
        <city>Mont-Godinne</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.uzgent.be</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ventral hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Hernia, Ventral</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/NCT01719718
org study id: 2012/075
nct id: NCT01719718
lead sponsor: 
has dmc: No
A multicenter prospective randomized controlled trial comparing closure versus non-closure of
      the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in
      laparoscopic ventral hernia repair.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Seroma formation after 4 weeks.
time frame: 4 weeks after surgery.
description: The seroma formation is checked by clinical evaluation.
measure: Pain, discomfort and esthetic evaluation after 4 weeks.
time frame: 4 weeks after surgery.
description: Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.
measure: Pain, discomfort and esthetic evaluation after 1 year.
time frame: 1 year after surgery.
description: Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.
measure: Pain, discomfort and esthetic evaluation after 2 years.
time frame: 2 years after surgery.
description: Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.
arm group label: Closure
arm group type: Active Comparator
arm group label: Non-Closure
arm group type: Sham Comparator
intervention type: Procedure
intervention name: Closure of hernia defect.
description: Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
arm group label: Closure
intervention type: Procedure
intervention name: No closure of the hernia defect.
description: Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).
arm group label: Non-Closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederik Berrevoet, MD, PhD, FACS
role: Principal Investigator
affiliation: University Hospital, Ghent
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
url: http://www.uzgent.be
description: Related Info
responsible party type: Sponsor
mesh term: Hernia
mesh term: Recurrence
mesh term: Hernia, Ventral