<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/NCT04422197</url>
  </required_header>
  <id_info>
    <org_study_id>R.19.05.515</org_study_id>
    <nct_id>NCT04422197</nct_id>
  </id_info>
  <brief_title>This Randomized Controlled Study Aims to Investigate the Effect of Botox Injection in Abdominal Wall Muscle Post Major Abdominal Surgery in Terms of Postoperative Pain, Incidence of Incisional Hernia.</brief_title>
  <official_title>Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery</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 This randomized controlled study aims to investigate the effect of botox&#xD;
      injection in abdominal wall muscle post major abdominal surgery in terms of postoperative&#xD;
      pain, incidence of incisional hernia Study design and setting This is a double-blind&#xD;
      prospective randomized controlled trial that will be conducted in the general surgery&#xD;
      department and colorectal surgery unit of Mansoura University hospital in the period from&#xD;
      June 2019 to June2020. The patient's recruitment process will be started and continued for&#xD;
      one year after getting the approval from the local Institutional Review Board in Mansoura&#xD;
      University in concordance with the Helsinki Declaration Principals. The data will be&#xD;
      collected and analyzed prospectively. A signed informed consent will be obtained from every&#xD;
      patient before enrollment highlighting the possible future publication. On request, patients&#xD;
      can be excluded from the study at any time if they do not want to continue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">December 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of incisional hernia.</measure>
    <time_frame>one year</time_frame>
    <description>incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hernia, Abdominal</condition>
  <arm_group>
    <arm_group_label>Patients with ultrasound-guided botox injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with no botox injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with major abdominal surgery without botox injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Botox</intervention_name>
    <description>effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.</description>
    <arm_group_label>Patients with ultrasound-guided botox injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery without botox injection</intervention_name>
    <description>surgery without botox injection</description>
    <arm_group_label>Patients with no botox injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients with major abdominal surgery including trauma and elective exploration surgery,&#xD;
        damage control surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patients with myopathies&#xD;
&#xD;
          -  motor polyneuropathies, impaired neuromuscular transmission (Myasthenia Gravis)&#xD;
&#xD;
          -  complicated Chronic Obstructive Pulmonary Disease (COPD),&#xD;
&#xD;
          -  necrotizing fasciitis of the trunk&#xD;
&#xD;
          -  unfit for general anesthesia&#xD;
&#xD;
          -  patients with psychiatric disorders&#xD;
&#xD;
          -  patients with drug abuse or history of opioid intake&#xD;
&#xD;
          -  chronic pain disorder&#xD;
&#xD;
          -  coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 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>
  <overall_contact_backup>
    <last_name>Mahmoud Abdelnaby</last_name>
    <phone>01099222561</phone>
    <email>Abdelshafymahmoud@gmail.com</email>
  </overall_contact_backup>
  <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>December 2019</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 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>
    <mesh_term>Hernia, Abdominal</mesh_term>
    <mesh_term>Internal Hernia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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/NCT04422197
org study id: R.19.05.515
nct id: NCT04422197
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the work This randomized controlled study aims to investigate the effect of botox
      injection in abdominal wall muscle post major abdominal surgery in terms of postoperative
      pain, incidence of incisional hernia Study design and setting This is a double-blind
      prospective randomized controlled trial that will be conducted in the general surgery
      department and colorectal surgery unit of Mansoura University hospital in the period from
      June 2019 to June2020. The patient's recruitment process will be started and continued for
      one year after getting the approval from the local Institutional Review Board in Mansoura
      University in concordance with the Helsinki Declaration Principals. The data will be
      collected and analyzed prospectively. A signed informed consent will be obtained from every
      patient before enrollment highlighting the possible future publication. On request, patients
      can be excluded from the study at any time if they do not want to continue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: incidence of incisional hernia.
time frame: one year
description: incidence of incisional hernia.Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
arm group label: Patients with ultrasound-guided botox injection
arm group type: Active Comparator
description: Effect of Botox injection on lateral abdominal wall muscles after major open abdominal surgery
arm group label: Patients with no botox injection
arm group type: Active Comparator
description: Patients with major abdominal surgery without botox injection
intervention type: Biological
intervention name: Botox
description: effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.
arm group label: Patients with ultrasound-guided botox injection
intervention type: Procedure
intervention name: surgery without botox injection
description: surgery without botox injection
arm group label: Patients with no botox injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mohamed Arnouse
phone: 01099222561
email: drmhamdy@mans.edu.eg
last name: Mahmoud Abdelnaby
phone: 01099222561
email: Abdelshafymahmoud@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Abdominal
mesh term: Internal Hernia
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA