<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/NCT03766061</url>
  </required_header>
  <id_info>
    <org_study_id>s8</org_study_id>
    <nct_id>NCT03766061</nct_id>
  </id_info>
  <brief_title>Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair</brief_title>
  <official_title>Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Services Hospital, Lahore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Services Hospital, Lahore</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>
      It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with&#xD;
      sublay mesh hernioplasty for paraumbilical hernia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Percentage of patients presenting with recurrence of hernia</measure>
    <time_frame>8 months</time_frame>
    <description>Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain from score 1 to 10</measure>
    <time_frame>3 days</time_frame>
    <description>Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Stay duration in days</measure>
    <time_frame>1 week</time_frame>
    <description>hospital stay (duration of patient from surgery to discharge) after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Paraumbilical Hernia</condition>
  <arm_group>
    <arm_group_label>Onlay Mesh Hernioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sublay Mesh Hernioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Onlay mesh Hernioplasty</intervention_name>
    <description>Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath</description>
    <arm_group_label>Onlay Mesh Hernioplasty</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sublay Mesh Hernioplasty</intervention_name>
    <description>Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space</description>
    <arm_group_label>Sublay Mesh Hernioplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both sexes and age 20 years and above with paraumblical hernia Defect size&#xD;
             3 to 6cm in greatest diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or&#xD;
             strangulated hernia Uncontrolled diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmmood Ayyaz, mbbs, fcps</last_name>
    <role>Study Director</role>
    <affiliation>Services Hospital, Lahore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Services hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Services Hospital, Lahore</investigator_affiliation>
    <investigator_full_name>Dr. SamiUllah</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03766061
org study id: s8
nct id: NCT03766061
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with
      sublay mesh hernioplasty for paraumbilical hernia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients presenting with recurrence of hernia
time frame: 8 months
description: Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery
measure: Postoperative pain from score 1 to 10
time frame: 3 days
description: Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum
measure: Hospital Stay duration in days
time frame: 1 week
description: hospital stay (duration of patient from surgery to discharge) after surgery
arm group label: Onlay Mesh Hernioplasty
arm group type: Active Comparator
description: In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath
arm group label: Sublay Mesh Hernioplasty
arm group type: Active Comparator
description: In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space
intervention type: Procedure
intervention name: Onlay mesh Hernioplasty
description: Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath
arm group label: Onlay Mesh Hernioplasty
intervention type: Procedure
intervention name: Sublay Mesh Hernioplasty
description: Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space
arm group label: Sublay Mesh Hernioplasty
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mahmmood Ayyaz, mbbs, fcps
role: Study Director
affiliation: Services Hospital, Lahore
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Services Hospital, Lahore
investigator full name: Dr. SamiUllah
investigator title: Principle investigator
mesh term: Hernia
sharing ipd: Undecided