<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/NCT01678157</url>
  </required_header>
  <id_info>
    <org_study_id>0314-11-FB</org_study_id>
    <nct_id>NCT01678157</nct_id>
  </id_info>
  <brief_title>Use of Strattice Mesh in Paraesophageal Hernia Surgery</brief_title>
  <acronym>Strattice</acronym>
  <official_title>Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LifeCell</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to examine the safety and efficacy of porcine acellular dermal&#xD;
      matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of&#xD;
      laparoscopic large paraesophageal hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either&#xD;
      synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this&#xD;
      study is to examine the safety and efficacy of porcine acellular dermal matrix mesh&#xD;
      (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large&#xD;
      paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult&#xD;
      (&gt;19 years of age) patients will be selected based on inclusion and exclusion criteria.&#xD;
      Patients who meet the criteria will be enrolled in the study. Information related to&#xD;
      recurrence rates based on follow-up visits will be analyzed to determine the efficacy of&#xD;
      Strattice in the prevention of large hernia recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2012</start_date>
  <completion_date type="Actual">May 1, 2015</completion_date>
  <primary_completion_date type="Actual">May 1, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hernia recurrence</measure>
    <time_frame>1 year post-surgery</time_frame>
    <description>A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of reflux symptoms</measure>
    <time_frame>2 weeks, 6 months and 1 year post-surgery</time_frame>
    <description>Patients will be evaluated for recurrence of reflux symptoms at the three postoperative visits. If recurrence warrants, a barium swallow with x-rays will be performed prior to 1-year primary outcome barium swallow test</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Esophageal Hernia</condition>
  <condition>Hernia, Esophageal</condition>
  <condition>Hernia, Paraesophageal</condition>
  <condition>Hiatal Hernia</condition>
  <condition>Paraesophageal Hiatal Hernia</condition>
  <condition>Sliding Esophageal Hernia</condition>
  <condition>Sliding Hiatal Hernia</condition>
  <arm_group>
    <arm_group_label>Documented symptomatic paraesophageal hernia</arm_group_label>
    <description>Documented symptomatic paraesophageal hernia.&#xD;
Greater than 5 cm hiatal hernia on upper gastrointestinal study.&#xD;
Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.&#xD;
Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn,dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia.&#xD;
Consenting adult 19 years of age or older&#xD;
Must be able to participate in follow-up evaluation.&#xD;
Free of cognitive impairment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults over 19 years of age with paraesophageal hernia greater than 5 cm.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented symptomatic paraesophageal hernia.&#xD;
&#xD;
          -  Greater than 5 cm hiatal hernia on upper gastrointestinal study.&#xD;
&#xD;
          -  Evidence that the stomach or other viscera is present in the hernia and does not&#xD;
             spontaneously reduce from the mediastinum.&#xD;
&#xD;
          -  Significant symptoms or signs of a paraesophageal hernia including but not limited to&#xD;
             heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain,&#xD;
             early satiety, odynophagia, or chronic anemia.&#xD;
&#xD;
          -  Consenting adult 19 years of age or older&#xD;
&#xD;
          -  Must be able to participate in follow-up evaluation.&#xD;
&#xD;
          -  Free of cognitive impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents (19 years of age or younger).&#xD;
&#xD;
          -  Pregnant and breast feeding patients.&#xD;
&#xD;
          -  Vulnerable subjects such as pregnant women, children less than 19 years age, and&#xD;
             decisionally impaired persons.&#xD;
&#xD;
          -  Patients with previous operation of the esophagus or stomach.&#xD;
&#xD;
          -  Patients with associated gastrointestinal diseases that require extensive medical or&#xD;
             surgical intervention that might interfere with quality of life assessment (e.g.&#xD;
             Crohn's disease).&#xD;
&#xD;
          -  Patients with emergent operation for acute gastric volvulus.&#xD;
&#xD;
          -  Patients with known sensitivity to porcine material.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dmitry Oleynikov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Esophageal Hernia</keyword>
  <keyword>Hernia, Esophageal</keyword>
  <keyword>Hernia, Paraesophageal</keyword>
  <keyword>Hiatal Hernia</keyword>
  <keyword>Paraesophageal Hiatal Hernia</keyword>
  <keyword>Sliding Esophageal Hernia</keyword>
  <keyword>Sliding Hiatal Hernia</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/NCT01678157
org study id: 0314-11-FB
nct id: NCT01678157
lead sponsor: 
collaborator: 
has dmc: Yes
The objective of this study is to examine the safety and efficacy of porcine acellular dermal
      matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of
      laparoscopic large paraesophageal hernia repair.
Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either
      synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this
      study is to examine the safety and efficacy of porcine acellular dermal matrix mesh
      (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large
      paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult
      (>19 years of age) patients will be selected based on inclusion and exclusion criteria.
      Patients who meet the criteria will be enrolled in the study. Information related to
      recurrence rates based on follow-up visits will be analyzed to determine the efficacy of
      Strattice in the prevention of large hernia recurrence.
observational model: Cohort
time perspective: Prospective
measure: Hernia recurrence
time frame: 1 year post-surgery
description: A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any
measure: Recurrence of reflux symptoms
time frame: 2 weeks, 6 months and 1 year post-surgery
description: Patients will be evaluated for recurrence of reflux symptoms at the three postoperative visits. If recurrence warrants, a barium swallow with x-rays will be performed prior to 1-year primary outcome barium swallow test
arm group label: Documented symptomatic paraesophageal hernia
description: Documented symptomatic paraesophageal hernia.
Greater than 5 cm hiatal hernia on upper gastrointestinal study.
Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.
Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn,dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia.
Consenting adult 19 years of age or older
Must be able to participate in follow-up evaluation.
Free of cognitive impairment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Dmitry Oleynikov, MD
role: Principal Investigator
affiliation: University of Nebraska
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Hiatal