<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/NCT04419844</url>
  </required_header>
  <id_info>
    <org_study_id>R.19.03.451 - 2019/03/11</org_study_id>
    <nct_id>NCT04419844</nct_id>
  </id_info>
  <brief_title>Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .</brief_title>
  <official_title>Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .</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 component separation (TAR)&#xD;
      technique with or without Botox injection for open huge ventral hernia and large abdominal&#xD;
      wall defect repair. The primary outcome will be recurrence while the secondary outcome will&#xD;
      be infection, postoperative complications (bleeding and dehiscence), pain score, operative&#xD;
      time, hospitalization, need for drain, time for drain removal and pulmonary function test&#xD;
      before and after surgery.&#xD;
&#xD;
      This prospective clinical study will be performed on 40 eligible patients admitted to general&#xD;
      surgery department at Mansoura University Hospi&#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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence</measure>
    <time_frame>one year</time_frame>
    <description>Recurrence of the ventral hernia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>TAR Technique</condition>
  <arm_group>
    <arm_group_label>TAR with Botox</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect Botox injection .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAR without Botox</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect without Botox injection .</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tar with Botox</intervention_name>
    <description>Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .</description>
    <arm_group_label>TAR with Botox</arm_group_label>
    <arm_group_label>TAR without Botox</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient fit for general anesthesia with huge ventral hernia (primary, incisional&#xD;
             or recurrent).Any patient with large abdominal wall defect secondary to abdominal wall&#xD;
             tumor excision or burst after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unfit for general anaesthesia. Poor pulmonary function tests.&#xD;
             Pregnant females. Patient younger than 18 years. Immunodeficiency. Patient with&#xD;
             psychiatric disease disabling surgical intervention. Patients who refuse to&#xD;
             participate in our study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 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 3, 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, Abdominal</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
    <mesh_term>Internal 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/NCT04419844
org study id: R.19.03.451 - 2019/03/11
nct id: NCT04419844
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the work In this study, we will evaluate posterior component separation (TAR)
      technique with or without Botox injection for open huge ventral hernia and large abdominal
      wall defect repair. 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.

      This prospective clinical study will be performed on 40 eligible patients admitted to general
      surgery department at Mansoura University Hospi
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence
time frame: one year
description: Recurrence of the ventral hernia
arm group label: TAR with Botox
arm group type: Active Comparator
description: Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect Botox injection .
arm group label: TAR without Botox
arm group type: Active Comparator
description: Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect without Botox injection .
intervention type: Procedure
intervention name: Tar with Botox
description: Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .
arm group label: TAR with Botox
arm group label: TAR without Botox
criteria: 
gender: All
minimum age: 12 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, Abdominal
mesh term: Hernia, Ventral
mesh term: Internal Hernia