<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/NCT01727050</url>
  </required_header>
  <id_info>
    <org_study_id>FSMSLH</org_study_id>
    <nct_id>NCT01727050</nct_id>
  </id_info>
  <brief_title>Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty</brief_title>
  <official_title>Randomized Prospective Trial of Fibrin Sealant Spray Versus Mechanical Stapling in Laparoscopic Totally Extraperitoneal Hernioplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for&#xD;
      the repair of primary unilateral inguinal hernia. Previous studies showed that patients&#xD;
      underwent TEP have less post-operative pain and earlier return to normal activities. However,&#xD;
      chronic pain is still a major issue affecting quality of life after TEP with a reported&#xD;
      incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation&#xD;
      to prevent mesh migration but nerve entrapment by staples causing intractable pain had been&#xD;
      reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS)&#xD;
      in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for&#xD;
      application of FS laparoscopically is now available which can achieve mesh fixation by using&#xD;
      fewer amounts of FS.&#xD;
&#xD;
      In this study, the investigators aim to compare the effectiveness of using fibrin spray for&#xD;
      mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized&#xD;
      controlled trial by allocating patients in two study arm in random manner. The treatment&#xD;
      group will have the mesh fixed by fibrin sealant spray, whereas the control group will have&#xD;
      conventional mechanical staples for fixation. Operative procedures and post-operative&#xD;
      management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month&#xD;
      after operation to evaluate the operative results and the incidence of chronic pain. Any&#xD;
      complications related to the mesh and operation will also be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2007</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of chronic pain</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of acute pain</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidities</measure>
    <time_frame>30 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Hernia</condition>
  <arm_group>
    <arm_group_label>Mechanical stapling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fibrin sealant spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fibrin sealant spray</intervention_name>
    <description>Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter</description>
    <arm_group_label>Fibrin sealant spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mechanical stapling</intervention_name>
    <description>Fixation of mesh would be performed using mechanical staplers</description>
    <arm_group_label>Mechanical stapling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive male patients aged between 18 to 70 years with reducible unilateral&#xD;
             inguinal hernia undergoing day-case TEP under general anaesthesia will be considered&#xD;
             eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral hernia, recurrent hernia, partially reducible or strangulated hernia, large&#xD;
             inguinal-scrotal hernia, previous abdominal incision (including previous contralateral&#xD;
             hernia repair), peripheral neuropathy, coagulopathy or taking anticoagulation drugs,&#xD;
             end-stage renal failure, cirrhosis, impaired cognitive function and those not consent&#xD;
             to study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Surgery, Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 16, 2012</last_update_submitted>
  <last_update_submitted_qc>November 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Anthony Teoh</investigator_full_name>
    <investigator_title>Honorary Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</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/NCT01727050
org study id: FSMSLH
nct id: NCT01727050
lead sponsor: 
has dmc: No
Laparoscopic totally extraperitoneal hernioplasty (TEP) is one of the treatment options for
      the repair of primary unilateral inguinal hernia. Previous studies showed that patients
      underwent TEP have less post-operative pain and earlier return to normal activities. However,
      chronic pain is still a major issue affecting quality of life after TEP with a reported
      incidence of 9.2-22.5%. Mechanical stapling is the most commonly used method of mesh fixation
      to prevent mesh migration but nerve entrapment by staples causing intractable pain had been
      reported. Recently several clinical trials showed that mesh fixation with fibrin sealant (FS)
      in TEP resulted in less chronic pain but increased incidence of seroma. A spraying device for
      application of FS laparoscopically is now available which can achieve mesh fixation by using
      fewer amounts of FS.

      In this study, the investigators aim to compare the effectiveness of using fibrin spray for
      mesh fixation in reducing chronic pain after TEP. The investigators performed a randomized
      controlled trial by allocating patients in two study arm in random manner. The treatment
      group will have the mesh fixed by fibrin sealant spray, whereas the control group will have
      conventional mechanical staples for fixation. Operative procedures and post-operative
      management for the 2 groups will be identical. They will be follow-up at 1-month and 6-month
      after operation to evaluate the operative results and the incidence of chronic pain. Any
      complications related to the mesh and operation will also be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of chronic pain
time frame: 6 months
measure: Severity of acute pain
time frame: 1 week
measure: Morbidities
time frame: 30 day
measure: Recurrence rate
time frame: 6 month
measure: Quality of life assessment
time frame: 6 months
arm group label: Mechanical stapling
arm group type: Active Comparator
arm group label: Fibrin sealant spray
arm group type: Active Comparator
intervention type: Device
intervention name: Fibrin sealant spray
description: Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter
arm group label: Fibrin sealant spray
intervention type: Device
intervention name: Mechanical stapling
description: Fixation of mesh would be performed using mechanical staplers
arm group label: Mechanical stapling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Anthony Teoh
investigator title: Honorary Assistant Professor
mesh term: Hernia
mesh term: Fibrin Tissue Adhesive