<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/NCT02242526</url>
  </required_header>
  <id_info>
    <org_study_id>SB-568818</org_study_id>
    <nct_id>NCT02242526</nct_id>
  </id_info>
  <brief_title>Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia</brief_title>
  <official_title>Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose a randomized, single blinded controlled trial to compare the use of&#xD;
      synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of&#xD;
      care surgical modalities. The investigators hypothesize that use of synthetic mesh will have&#xD;
      lower recurrence at these time points compared to use of biologic mesh.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized to either a synthetic (light weight synthetic or biologic (small&#xD;
      intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as&#xD;
      a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal&#xD;
      hernia repair, patients will be followed with both subjective and objective measures.&#xD;
      Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and&#xD;
      60- month periods; objective evaluation will include Upper GI study /pH probe study for&#xD;
      symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize&#xD;
      that use of synthetic mesh will have lower recurrence at these time points compared to use of&#xD;
      biologic mesh.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess for reappearance of hiatal hernia and reflux</measure>
    <time_frame>6 months, 60 months</time_frame>
    <description>Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life questionnaire</measure>
    <time_frame>Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months</time_frame>
    <description>Quality of life questionnaire containing 36 questions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">312</enrollment>
  <condition>Hiatal Hernia</condition>
  <arm_group>
    <arm_group_label>Parietex™ Composite Hiatal Mesh, North Haven, CT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biodesign™ Surgisis® Graft, Cook Medical, Bloomington</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Parietex™ Composite Hiatal Mesh, North Haven, CT</intervention_name>
    <description>Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.</description>
    <arm_group_label>Biodesign™ Surgisis® Graft, Cook Medical, Bloomington</arm_group_label>
    <arm_group_label>Parietex™ Composite Hiatal Mesh, North Haven, CT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biodesign™ Surgisis® Graft, Cook Medical, Bloomington</intervention_name>
    <description>Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.</description>
    <arm_group_label>Biodesign™ Surgisis® Graft, Cook Medical, Bloomington</arm_group_label>
    <arm_group_label>Parietex™ Composite Hiatal Mesh, North Haven, CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female gender&#xD;
&#xD;
          -  Age&gt;18 years&#xD;
&#xD;
          -  Absence of chronic medical conditions that will affect the quality of life survey,&#xD;
             such as fibromyalgia, SLE, Crohn's disease, etc.&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Able and willing to participate in follow-up evaluations&#xD;
&#xD;
          -  Upper GI with a documented hiatal hernia greater than 5cm&#xD;
&#xD;
          -  Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain,&#xD;
             regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early&#xD;
             satiety.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery of the esophagus and/or the stomach&#xD;
&#xD;
          -  Emergent operation for acute gastric volvulus or strangulation&#xD;
&#xD;
          -  Biopsy consistent with malignancy&#xD;
&#xD;
          -  Body Mass Index (BMI) over 35kg/m2&#xD;
&#xD;
          -  Inability to perform primary closure of crura&#xD;
&#xD;
          -  Active smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurora Pryor, MD</last_name>
      <phone>631-444-7788</phone>
      <email>aurora.pryor@stonybrookmedicine.edu</email>
    </contact>
    <contact_backup>
      <last_name>Shabana Humayon, MD</last_name>
      <phone>6316380292</phone>
      <email>shabana.humayon@stonybrookmedicine.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Aurora Pryor, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hiatal hernia, recurrence, biologic mesh, synthetic mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Hiatal</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/NCT02242526
org study id: SB-568818
nct id: NCT02242526
lead sponsor: 
has dmc: No
The investigators propose a randomized, single blinded controlled trial to compare the use of
      synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of
      care surgical modalities. The investigators hypothesize that use of synthetic mesh will have
      lower recurrence at these time points compared to use of biologic mesh.
Patients will be randomized to either a synthetic (light weight synthetic or biologic (small
      intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as
      a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal
      hernia repair, patients will be followed with both subjective and objective measures.
      Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and
      60- month periods; objective evaluation will include Upper GI study /pH probe study for
      symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize
      that use of synthetic mesh will have lower recurrence at these time points compared to use of
      biologic mesh.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Assess for reappearance of hiatal hernia and reflux
time frame: 6 months, 60 months
description: Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux.
measure: Quality of Life questionnaire
time frame: Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months
description: Quality of life questionnaire containing 36 questions
arm group label: Parietex™ Composite Hiatal Mesh, North Haven, CT
arm group type: Active Comparator
description: Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.
arm group label: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
arm group type: Active Comparator
description: Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia
intervention type: Device
intervention name: Parietex™ Composite Hiatal Mesh, North Haven, CT
description: Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.
arm group label: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
arm group label: Parietex™ Composite Hiatal Mesh, North Haven, CT
intervention type: Device
intervention name: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
description: Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.
arm group label: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
arm group label: Parietex™ Composite Hiatal Mesh, North Haven, CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Hiatal