<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/NCT04418349</url>
  </required_header>
  <id_info>
    <org_study_id>R.19.07.563 - 2019/07/15</org_study_id>
    <nct_id>NCT04418349</nct_id>
  </id_info>
  <brief_title>Evaluation of Posterior Component Separation Modified TAR Technique &quot;Transversus Abdominids Release&quot; in the Treatment of Parastomal Hernia</brief_title>
  <official_title>Evaluation of Posterior Component Separation Modified TAR Technique &quot;Transversus Abdominids Release&quot; in the Treatment of Parastomal Hernia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the work In this study, we will evaluate posterior Evaluation of posterior component&#xD;
      separation modified TAR technique &quot;Transversus Abdominids Release&quot; in the treatment of&#xD;
      parastomal hernia. The primary outcome will be recurrence while the secondary outcome will be&#xD;
      infection, postoperative complications (bleeding and dehiscence), pain score, operative time,&#xD;
      hospitalization, need for drain, time for drain removal and pulmonary function test before&#xD;
      and after surgery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">June 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>one year</time_frame>
    <description>Recurrence rate of parastomal hernias</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>TAR Technique</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>posterior component separation modified TAR technique &quot;Transversus Abdominids Release&quot;</intervention_name>
    <description>Evaluation of posterior component separation modified TAR technique &quot;Transversus Abdominids Release&quot; in the treatment of parastomal hernia</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient fit for general anesthesia with parastomal herniation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unfit for general anaesthesia.&#xD;
&#xD;
          -  Poor pulmonary function tests.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Patient younger than 18 years.&#xD;
&#xD;
          -  Immunodeficiency.&#xD;
&#xD;
          -  Patient with psychiatric disease disabling surgical intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed Arnouse</last_name>
    <phone>01099222561</phone>
    <email>drmhamdy@mans.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Hamada Mohamed Hamada</last_name>
      <phone>+20 109 212 7930</phone>
      <email>irb.mfm@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</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/NCT04418349
org study id: R.19.07.563 - 2019/07/15
nct id: NCT04418349
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the work In this study, we will evaluate posterior Evaluation of posterior component
      separation modified TAR technique "Transversus Abdominids Release" in the treatment of
      parastomal hernia. The primary outcome will be recurrence while the secondary outcome will be
      infection, postoperative complications (bleeding and dehiscence), pain score, operative time,
      hospitalization, need for drain, time for drain removal and pulmonary function test before
      and after surgery
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence rate
time frame: one year
description: Recurrence rate of parastomal hernias
intervention type: Procedure
intervention name: posterior component separation modified TAR technique "Transversus Abdominids Release"
description: Evaluation of posterior component separation modified TAR technique "Transversus Abdominids Release" in the treatment of parastomal hernia
criteria: 
gender: All
minimum age: 10 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mohamed Arnouse
phone: 01099222561
email: drmhamdy@mans.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Hernia