<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/NCT03793738</url>
  </required_header>
  <id_info>
    <org_study_id>01004006344</org_study_id>
    <nct_id>NCT03793738</nct_id>
  </id_info>
  <brief_title>Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias</brief_title>
  <official_title>Anterior Component Separation Versus Posterior Component Separation for Repair of Large Ventral Hernias: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zaza Demetrashvili</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tbilisi State Medical University</source>
  <brief_summary>
    <textblock>
      This study evaluates effect of anterior component separation and posterior component&#xD;
      separation and transversus abdominis muscle release methods for treatment of midline ventral&#xD;
      hernias.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The anterior component separation technique requires an extensive subcutaneous flap&#xD;
      elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus&#xD;
      sheath.&#xD;
&#xD;
      The posterior component separation technique utilized the retromuscular space, accessed by&#xD;
      incising the posterior rectus sheath and dissecting the posterior sheath between the internal&#xD;
      oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the&#xD;
      posterior sheath back to the transversus abdominal muscle and accessed the space between&#xD;
      muscle and trasversalis fascia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Hernia recurrence</measure>
    <time_frame>during 3 year after surgery</time_frame>
    <description>Develop of ventral hernia recurrence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound complications</measure>
    <time_frame>30 day after surgery</time_frame>
    <description>Develop of wound complications (seroma, hematoma, surgical site infection)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Large Midline Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>anterior component separation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>posterior component separation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anterior component separation</intervention_name>
    <arm_group_label>anterior component separation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterior component separation</intervention_name>
    <arm_group_label>posterior component separation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subject has midline ventral hernia&#xD;
&#xD;
          -  patient's approval to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  strangulated hernia&#xD;
&#xD;
          -  patient's preference for either operative technique&#xD;
&#xD;
          -  patient's refusal to participate in the study&#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>Zaza Demetrashvili, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tbilisi State Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zaza Demetrashvili, MD, PhD</last_name>
    <phone>+995599217733</phone>
    <email>zdemetr@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>George Kenchadze, MD</last_name>
    <phone>+995599351249</phone>
    <email>gugaken@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tbilisi State Medical University</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zaza Demetrashvili</last_name>
      <email>zdemetr@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Zaza Demetrashvili</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Georgia</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tbilisi State Medical University</investigator_affiliation>
    <investigator_full_name>Zaza Demetrashvili</investigator_full_name>
    <investigator_title>Associate Professor, Surgery Department</investigator_title>
  </responsible_party>
  <keyword>anterior component separation, TAR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</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/NCT03793738
org study id: 01004006344
nct id: NCT03793738
lead sponsor: 
This study evaluates effect of anterior component separation and posterior component
      separation and transversus abdominis muscle release methods for treatment of midline ventral
      hernias.
The anterior component separation technique requires an extensive subcutaneous flap
      elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus
      sheath.

      The posterior component separation technique utilized the retromuscular space, accessed by
      incising the posterior rectus sheath and dissecting the posterior sheath between the internal
      oblique and transversus abdominis muscles. Transversus abdominis muscle release dissected the
      posterior sheath back to the transversus abdominal muscle and accessed the space between
      muscle and trasversalis fascia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hernia recurrence
time frame: during 3 year after surgery
description: Develop of ventral hernia recurrence
measure: Wound complications
time frame: 30 day after surgery
description: Develop of wound complications (seroma, hematoma, surgical site infection)
arm group label: anterior component separation
arm group type: Active Comparator
description: The anterior component separation technique requires an extensive subcutaneous flap elevation, incision of the external oblique aponeurosis, and incision of the posterior rectus sheath.
arm group label: posterior component separation
arm group type: Active Comparator
description: The posterior component separation technique utilized the retromuscular space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscles.
intervention type: Procedure
intervention name: Anterior component separation
arm group label: anterior component separation
intervention type: Procedure
intervention name: Posterior component separation
arm group label: posterior component separation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zaza Demetrashvili, PhD
role: Principal Investigator
affiliation: Tbilisi State Medical University
last name: Zaza Demetrashvili, MD, PhD
phone: +995599217733
email: zdemetr@yahoo.com
last name: George Kenchadze, MD
phone: +995599351249
email: gugaken@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Georgia
responsible party type: Sponsor-Investigator
investigator affiliation: Tbilisi State Medical University
investigator full name: Zaza Demetrashvili
investigator title: Associate Professor, Surgery Department
mesh term: Hernia
mesh term: Hernia, Ventral