<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/NCT03247985</url>
  </required_header>
  <id_info>
    <org_study_id>13-003616</org_study_id>
    <nct_id>NCT03247985</nct_id>
  </id_info>
  <brief_title>Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair</brief_title>
  <official_title>Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia&#xD;
      repair makes any difference in short-term pain or return to normal activities following the&#xD;
      operation. Other studies have shown no significant difference in hernia recurrence rate when&#xD;
      metal tacks are not used to hold the mesh in place.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be placed into two groups. One group of participants will have mesh tacked&#xD;
      into place for their hernia repairs. The other group will have self-fixating mesh into place.&#xD;
      Both groups will have a piece of mesh that will widely cover the hernia defect. Before&#xD;
      surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no&#xD;
      pain and 10 is the worst pain they can imagine. Investigators will record information about&#xD;
      general medical condition, medications and activity level. During the operation information&#xD;
      will be recorded about the pain medicines the participant may receive. In the recovery room&#xD;
      the participant will be asked to rate their pain on the 0-10 scale and more information will&#xD;
      be recorded about any additional pain medicines that they may receive and assess activity&#xD;
      level. Following surgery, Investigators will contact the participants by survey to obtain&#xD;
      more information about pain level, medication use, and activity level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">November 30, 2015</completion_date>
  <primary_completion_date type="Actual">November 30, 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Operative Time</measure>
    <time_frame>First incision to closure, approximately one hour</time_frame>
    <description>Length of time needed to complete surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Early Postoperative Complications</measure>
    <time_frame>Within 30 days</time_frame>
    <description>Any complication which occurred within 30 days after the operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Baseline</measure>
    <time_frame>baseline</time_frame>
    <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score at One Week</measure>
    <time_frame>One Week Postoperative</time_frame>
    <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Four Weeks</measure>
    <time_frame>Four Weeks Postoperative</time_frame>
    <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Hernia, Inguinal</condition>
  <arm_group>
    <arm_group_label>PROLENE Polypropylene Tacking Mesh</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ProGrip Self-fixating Mesh</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PROLENE Polypropylene Tacking Mesh</intervention_name>
    <description>Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
    <arm_group_label>PROLENE Polypropylene Tacking Mesh</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProGrip Self-fixating Mesh</intervention_name>
    <description>ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
    <arm_group_label>ProGrip Self-fixating Mesh</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All patients regardless of sex or age who were diagnosed with a inguinal hernia and&#xD;
        underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in&#xD;
        Rochester, Minnesota from June 2013 - June 2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients who did not elect to undergo a hernia repair or who elected to undergo a&#xD;
        different type of hernia repair instead of a TEP procedure.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Farley</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>October 19, 2017</results_first_submitted>
  <results_first_submitted_qc>October 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2017</results_first_posted>
  <last_update_submitted>May 17, 2018</last_update_submitted>
  <last_update_submitted_qc>May 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>David R. Farley</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Mesh</keyword>
  <keyword>Repair</keyword>
  <keyword>Peritoneal</keyword>
  <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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at the Mayo Clinic in Rochester, Minnesota from June 2013 to June 2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>PROLENE Polypropylene Tacking Mesh</title>
          <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
        </group>
        <group group_id="P2">
          <title>ProGrip Self-fixating Mesh</title>
          <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PROLENE Polypropylene Tacking Mesh</title>
          <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
        </group>
        <group group_id="B2">
          <title>ProGrip Self-fixating Mesh</title>
          <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" spread="11"/>
                    <measurement group_id="B2" value="55" spread="11"/>
                    <measurement group_id="B3" value="55" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" spread="10"/>
                    <measurement group_id="B2" value="30" spread="4"/>
                    <measurement group_id="B3" value="30" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Site of Hernia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Unilateral</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilateral</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Operative Time</title>
        <description>Length of time needed to complete surgery.</description>
        <time_frame>First incision to closure, approximately one hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PROLENE Polypropylene Tacking Mesh</title>
            <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
          </group>
          <group group_id="O2">
            <title>ProGrip Self-fixating Mesh</title>
            <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Operative Time</title>
          <description>Length of time needed to complete surgery.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bilateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" spread="6.5"/>
                    <measurement group_id="O2" value="84" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unilateral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="12"/>
                    <measurement group_id="O2" value="66" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between groups for bilateral operative time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.17</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison between groups for unilateral operative time.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.09</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Early Postoperative Complications</title>
        <description>Any complication which occurred within 30 days after the operation.</description>
        <time_frame>Within 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PROLENE Polypropylene Tacking Mesh</title>
            <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
          </group>
          <group group_id="O2">
            <title>ProGrip Self-fixating Mesh</title>
            <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Early Postoperative Complications</title>
          <description>Any complication which occurred within 30 days after the operation.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overnight admittance to hospital</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary retention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Recurrence of hernia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Baseline</title>
        <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PROLENE Polypropylene Tacking Mesh</title>
            <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
          </group>
          <group group_id="O2">
            <title>ProGrip Self-fixating Mesh</title>
            <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Baseline</title>
          <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="1.196"/>
                    <measurement group_id="O2" value="1.5" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at One Week</title>
        <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
        <time_frame>One Week Postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PROLENE Polypropylene Tacking Mesh</title>
            <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
          </group>
          <group group_id="O2">
            <title>ProGrip Self-fixating Mesh</title>
            <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at One Week</title>
          <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.904"/>
                    <measurement group_id="O2" value="0.8" spread="0.747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A p-value of 0.05 was considered statistically significant.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Four Weeks</title>
        <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
        <time_frame>Four Weeks Postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PROLENE Polypropylene Tacking Mesh</title>
            <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
          </group>
          <group group_id="O2">
            <title>ProGrip Self-fixating Mesh</title>
            <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Four Weeks</title>
          <description>Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.236"/>
                    <measurement group_id="O2" value="0.3" spread="0.757"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PROLENE Polypropylene Tacking Mesh</title>
          <description>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.&#xD;
PROLENE Polypropylene Tacking Mesh: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks</description>
        </group>
        <group group_id="E2">
          <title>ProGrip Self-fixating Mesh</title>
          <description>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery&#xD;
ProGrip Self-fixating Mesh: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open &amp; laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of &quot;Velcro&quot; to the soft tissue surfaces resulting in self-fixation</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Admission to hospital</sub_title>
                <description>Bladder catheterization</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Inguinal Hernia Recurrence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The small sample size limits the power to reflect statistical differences. This study had a large number of bilateral repairs reflecting the inherent referral bias of our practice.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. David R. Farley</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-7565</phone>
      <email>farley.david@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03247985
org study id: 13-003616
nct id: NCT03247985
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia
      repair makes any difference in short-term pain or return to normal activities following the
      operation. Other studies have shown no significant difference in hernia recurrence rate when
      metal tacks are not used to hold the mesh in place.
Participants will be placed into two groups. One group of participants will have mesh tacked
      into place for their hernia repairs. The other group will have self-fixating mesh into place.
      Both groups will have a piece of mesh that will widely cover the hernia defect. Before
      surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no
      pain and 10 is the worst pain they can imagine. Investigators will record information about
      general medical condition, medications and activity level. During the operation information
      will be recorded about the pain medicines the participant may receive. In the recovery room
      the participant will be asked to rate their pain on the 0-10 scale and more information will
      be recorded about any additional pain medicines that they may receive and assess activity
      level. Following surgery, Investigators will contact the participants by survey to obtain
      more information about pain level, medication use, and activity level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean Operative Time
time frame: First incision to closure, approximately one hour
description: Length of time needed to complete surgery.
measure: Number of Participants With Early Postoperative Complications
time frame: Within 30 days
description: Any complication which occurred within 30 days after the operation.
measure: Pain Score at Baseline
time frame: baseline
description: Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
measure: Pain Score at One Week
time frame: One Week Postoperative
description: Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
measure: Pain Score at Four Weeks
time frame: Four Weeks Postoperative
description: Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
arm group label: PROLENE Polypropylene Tacking Mesh
arm group type: Active Comparator
description: Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.
arm group label: ProGrip Self-fixating Mesh
arm group type: Active Comparator
description: Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery
intervention type: Device
intervention name: PROLENE Polypropylene Tacking Mesh
description: Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
arm group label: PROLENE Polypropylene Tacking Mesh
intervention type: Device
intervention name: ProGrip Self-fixating Mesh
description: ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of "Velcro" to the soft tissue surfaces resulting in self-fixation
arm group label: ProGrip Self-fixating Mesh
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Farley
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: David R. Farley
investigator title: Principal Investigator
mesh term: Hernia
mesh term: Hernia, Inguinal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The small sample size limits the power to reflect statistical differences. This study had a large number of bilateral repairs reflecting the inherent referral bias of our practice.
point of contact: 