<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/NCT03765268</url>
  </required_header>
  <id_info>
    <org_study_id>s9</org_study_id>
    <nct_id>NCT03765268</nct_id>
  </id_info>
  <brief_title>Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair</brief_title>
  <official_title>Neurectomy Vs Nerve Sparing in Open Inguinal 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 treating inguinal hernia patients with&#xD;
      mesh hernioplasty and either neurectomy of iliohypogastric nerve and ilioinguinal neurectomy&#xD;
      or preservation comparing post operative acute or chronic pain&#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 developing chronic inguinodynia</measure>
    <time_frame>3 months</time_frame>
    <description>Excruciating Pain measured by visual analog score (with 1 being minimum score and 10 being maximum score) for more than 3 months in inguinal region after open mesh hernioplasty for inguinal hernia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Neurectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group we did mesh hernioplasty of inguinal hernia with neurectomy of iliohypogastric and ilioinguinal nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nerve Sparing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group we did mesh hernioplasty of inguinal hernia with preservation of iliohypogastric and ilioinguinal nerve</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neurectomy in inguinal hernia repair</intervention_name>
    <description>Mesh hernioplasty of inguinal hernia with neurectomy of ilioinguinal and iliohypogastric nerve</description>
    <arm_group_label>Neurectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>nerve sparing in inguinal hernia repair</intervention_name>
    <description>Mesh hernioplasty of inguinal hernia with sparing of ilioinguinal and iliohypogastric nerve</description>
    <arm_group_label>Nerve Sparing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients male, and age between 20 to 70 years Reducible inguinal hernia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Irreducible, obstructed or strangulated hernia uncontrolled diabetes&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 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 Lahore</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>February 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>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 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>
    <mesh_term>Hernia, Inguinal</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/NCT03765268
org study id: s9
nct id: NCT03765268
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is a randomized controlled trial in which we are treating inguinal hernia patients with
      mesh hernioplasty and either neurectomy of iliohypogastric nerve and ilioinguinal neurectomy
      or preservation comparing post operative acute or chronic pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: percentage of patients developing chronic inguinodynia
time frame: 3 months
description: Excruciating Pain measured by visual analog score (with 1 being minimum score and 10 being maximum score) for more than 3 months in inguinal region after open mesh hernioplasty for inguinal hernia
arm group label: Neurectomy
arm group type: Active Comparator
description: In this group we did mesh hernioplasty of inguinal hernia with neurectomy of iliohypogastric and ilioinguinal nerve
arm group label: Nerve Sparing
arm group type: Active Comparator
description: In this group we did mesh hernioplasty of inguinal hernia with preservation of iliohypogastric and ilioinguinal nerve
intervention type: Procedure
intervention name: Neurectomy in inguinal hernia repair
description: Mesh hernioplasty of inguinal hernia with neurectomy of ilioinguinal and iliohypogastric nerve
arm group label: Neurectomy
intervention type: Procedure
intervention name: nerve sparing in inguinal hernia repair
description: Mesh hernioplasty of inguinal hernia with sparing of ilioinguinal and iliohypogastric nerve
arm group label: Nerve Sparing
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 70 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
mesh term: Hernia, Inguinal
sharing ipd: Undecided