<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/NCT02206828</url>
  </required_header>
  <id_info>
    <org_study_id>COVSYMB0441</org_study_id>
    <nct_id>NCT02206828</nct_id>
  </id_info>
  <brief_title>The SymCHro - Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair</brief_title>
  <acronym>SymCHro</acronym>
  <official_title>Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this Observational Registry Study is to assess the short- and long-term clinical&#xD;
      outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal&#xD;
      wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use&#xD;
      (IFU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational multicenter registry study. One hundred consecutive, adult patients&#xD;
      scheduled for primary and incisional abdominal wall hernia surgeries using Symbotex™&#xD;
      Composite Mesh will be reported in the ClubHernie online database, with standard data&#xD;
      captured of all preoperative, perioperative and post-operative data, for patient's outcomes&#xD;
      measurements.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      Evaluate the incidence of peri-operative and post-operative complications, with postoperative&#xD;
      evaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month (D30 follow up),&#xD;
      1 year and 2 year follow up after primary and incisional abdominal wall hernia surgeries&#xD;
      using Symbotex™ Composite Mesh by open or laparoscopic approach (such as anticipated device&#xD;
      related complications such as pain, recurrence, complications related to adhesions, wound&#xD;
      complications, other postoperative complications, (SAE).&#xD;
&#xD;
      This online database consists of a systematic and consecutive data entry of all patients&#xD;
      treated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, with&#xD;
      standard data captured of all preoperative, perioperative and post-operative data.&#xD;
&#xD;
      The database is required to be completed anonymously. Quality data control of all data&#xD;
      captured into the online database will be performed by coherence analysis by Club Hernie&#xD;
      authorized representative;A statistical analysis plan will be developed by Covidien.&#xD;
&#xD;
      Study reported device-related events will be reviewed periodically to assess for any&#xD;
      potential trends&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2014</start_date>
  <completion_date type="Actual">May 22, 2017</completion_date>
  <primary_completion_date type="Actual">May 22, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Incidence of Peri-operative and Post-operative Complications</measure>
    <time_frame>Various (measured at 1 month, 1 Year &amp; 2 Year)</time_frame>
    <description>Primary endpoint focuses on complications (including recurrence) occurring during procedure, and in short, mid and long-term (measured at 1 month, 1 year and 2 year follow-up respectively) following ventral hernia repair.&#xD;
All peri-, intra- and post- operative complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Assessment Measured With VAS Score</measure>
    <time_frame>Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year</time_frame>
    <description>Pain assessment measured with VAS* score&#xD;
*VAS: The postoperative pain is assessed using a 0-10 Visual Analogue Scale. Worst pain experienced over the last 24 hours. Mild pain for VAS score between 0 and 3; Moderate pain for VAS score &gt; 3 and &gt; 6 ; Severe pain for VAS scores &gt; 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life for Patient</measure>
    <time_frame>Various ( 1 Month, 1 year and 2 Year follow up)</time_frame>
    <description>Quality of Life of patients treated for ventral hernia For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Various (1 year and 2 year)</time_frame>
    <description>Patient satisfaction For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)</measure>
    <time_frame>Day 0 Baseline</time_frame>
    <description>Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mesh Handling</measure>
    <time_frame>Day 0 Baseline</time_frame>
    <description>ease of use / mesh Handling Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia- Participant reflect surgeon who asses the feature of the mesh (for example, 68 surgeons agree that marking eases to place the mesh, 34 surgeons agree that the mesh is conformable to the anatomy etc..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair</measure>
    <time_frame>Baseline Day 0</time_frame>
    <description>Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Use of Symbotex™ Composite Mesh and Surgery Duration</measure>
    <time_frame>Baseline Day 0</time_frame>
    <description>Operative Time (min) for patients treated for ventral hernia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Use of Symbotex™ Composite Mesh and Hospital Stay Duration</measure>
    <time_frame>Baseline Day 0</time_frame>
    <description>Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Ventral Incisional Hernia</condition>
  <arm_group>
    <arm_group_label>1 GROUP</arm_group_label>
    <description>Only 1 group not predetermined</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients scheduled for primary and incisional abdominal wall hernia surgeries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The first one hundred consecutive adult patients scheduled for primary and incisional&#xD;
             abdominal wall hernia surgery by Club Hernie members surgeons using Symbotex™Composite&#xD;
             Mesh ;- All patients regardless of gender ≥ 18 years of age presenting with ventral&#xD;
             hernias.&#xD;
&#xD;
          -  Patients will be informed by surgeon with a written information notice of the nature&#xD;
             of the observational registry study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria outside the product IFU&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-François Gillion</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICMJE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Club Hernie association represented by Dr Gillion, in his capacity as President</name>
      <address>
        <city>Montrouge</city>
        <zip>92120</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>September 4, 2018</results_first_submitted>
  <results_first_submitted_qc>October 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 1, 2019</results_first_posted>
  <last_update_submitted>October 14, 2019</last_update_submitted>
  <last_update_submitted_qc>October 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HERNIA</keyword>
  <keyword>SYMCHRO</keyword>
  <keyword>SOFRADIM</keyword>
  <keyword>REGISTRY</keyword>
  <keyword>SYMBOTEX</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
    <mesh_term>Incisional Hernia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 20, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02206828/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 6, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02206828/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Symbotex Composite Mesh</title>
          <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>100 patients exhibited ventral hernia</population>
      <group_list>
        <group group_id="B1">
          <title>Symbotex Composite Mesh</title>
          <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </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="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.0" spread="13.7"/>
                  </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="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Peri-operative and Post-operative Complications</title>
        <description>Primary endpoint focuses on complications (including recurrence) occurring during procedure, and in short, mid and long-term (measured at 1 month, 1 year and 2 year follow-up respectively) following ventral hernia repair.&#xD;
All peri-, intra- and post- operative complications</description>
        <time_frame>Various (measured at 1 month, 1 Year &amp; 2 Year)</time_frame>
        <population>6 patients are lost to follow up at 1 year - 7 patients are lost to follow up at 2 year , it is described in the Participant Flow module Outcomes measure reflect Patients who completed each visits</population>
        <group_list>
          <group group_id="O1">
            <title>Recurence Rate at 1 Month</title>
            <description>Recurrence rate following patients treated for ventral hernia</description>
          </group>
          <group group_id="O2">
            <title>Recurrence Rate at 1 Year</title>
            <description>Recurrence rate following patients treated for ventral hernia</description>
          </group>
          <group group_id="O3">
            <title>Recurrence Rate at 2 Year</title>
            <description>Recurrence rate following patients treated for ventral hernia</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Peri-operative and Post-operative Complications</title>
          <description>Primary endpoint focuses on complications (including recurrence) occurring during procedure, and in short, mid and long-term (measured at 1 month, 1 year and 2 year follow-up respectively) following ventral hernia repair.&#xD;
All peri-, intra- and post- operative complications</description>
          <population>6 patients are lost to follow up at 1 year - 7 patients are lost to follow up at 2 year , it is described in the Participant Flow module Outcomes measure reflect Patients who completed each visits</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Assessment Measured With VAS Score</title>
        <description>Pain assessment measured with VAS* score&#xD;
*VAS: The postoperative pain is assessed using a 0-10 Visual Analogue Scale. Worst pain experienced over the last 24 hours. Mild pain for VAS score between 0 and 3; Moderate pain for VAS score &gt; 3 and &gt; 6 ; Severe pain for VAS scores &gt; 6</description>
        <time_frame>Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VAS Pain Assessment Day 0</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O2">
            <title>VAS Pain Assessment Day 1</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O3">
            <title>VAS Pain Assessment Day 8</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O4">
            <title>VAS Pain Assessment Month 1</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O5">
            <title>VAS Pain Assessment Month 3</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O6">
            <title>VAS Pain Assessment 1 Year</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O7">
            <title>VAS Pain Assessment 2 Year</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Assessment Measured With VAS Score</title>
          <description>Pain assessment measured with VAS* score&#xD;
*VAS: The postoperative pain is assessed using a 0-10 Visual Analogue Scale. Worst pain experienced over the last 24 hours. Mild pain for VAS score between 0 and 3; Moderate pain for VAS score &gt; 3 and &gt; 6 ; Severe pain for VAS scores &gt; 6</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="82"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="79"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.5"/>
                    <measurement group_id="O2" value="3.9" spread="1.8"/>
                    <measurement group_id="O3" value="2.0" spread="1.7"/>
                    <measurement group_id="O4" value="0.8" spread="1.8"/>
                    <measurement group_id="O5" value="0.2" spread="0.7"/>
                    <measurement group_id="O6" value="0.0" spread="0.0"/>
                    <measurement group_id="O7" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life for Patient</title>
        <description>Quality of Life of patients treated for ventral hernia For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.</description>
        <time_frame>Various ( 1 Month, 1 year and 2 Year follow up)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Quality of Life at 1 Month</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O2">
            <title>Quality of Life at 1 Year</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O3">
            <title>Quality of Life at 2 Year</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life for Patient</title>
          <description>Quality of Life of patients treated for ventral hernia For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Does the abdominal wall seem firm?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you feel a lump?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do you feel any pain or discomfort?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reoperation needed?</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="94"/>
                    <measurement group_id="O3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.</description>
        <time_frame>Various (1 year and 2 year)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Patient Satisfaction At 1 Year</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O2">
            <title>Patient Satisfaction At 2 Year</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Medium</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)</title>
        <description>Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia</description>
        <time_frame>Day 0 Baseline</time_frame>
        <population>Number of Hernia, some patients exhibits more than 1 hernia (100 patients with 105 ventral hernias) Ease of use: results is based on 100 patients and 105 hernias (100 patients enrolled and having 105 hernias) , However results reported of subjects with missing data or not applicable data respectively;</population>
        <group_list>
          <group group_id="O1">
            <title>Ease of Use - Mesh Flexibility</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O2">
            <title>Ease of Use - Mesh Easy to Trim</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O3">
            <title>Ease of Use - Mesh Easy to Insert</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O4">
            <title>Ease of Use - Mesh Memory Shape</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
          <group group_id="O5">
            <title>Ease of Use - Minimizing Visceral Attachment Property</title>
            <description>Ease of use Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
        </group_list>
        <measure>
          <title>Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)</title>
          <description>Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia</description>
          <population>Number of Hernia, some patients exhibits more than 1 hernia (100 patients with 105 ventral hernias) Ease of use: results is based on 100 patients and 105 hernias (100 patients enrolled and having 105 hernias) , However results reported of subjects with missing data or not applicable data respectively;</population>
          <units>Hernia</units>
          <param>Count of Units</param>
          <units_analyzed>Hernia</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="92"/>
                <count group_id="O5" value="89"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Hernia</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="80"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="96"/>
                <count group_id="O5" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Satisfying</title>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="102"/>
                    <measurement group_id="O4" value="94"/>
                    <measurement group_id="O5" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsatisfying</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mesh Handling</title>
        <description>ease of use / mesh Handling Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia- Participant reflect surgeon who asses the feature of the mesh (for example, 68 surgeons agree that marking eases to place the mesh, 34 surgeons agree that the mesh is conformable to the anatomy etc..</description>
        <time_frame>Day 0 Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mesh Positioning and Deployment</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
        </group_list>
        <measure>
          <title>Mesh Handling</title>
          <description>ease of use / mesh Handling Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia- Participant reflect surgeon who asses the feature of the mesh (for example, 68 surgeons agree that marking eases to place the mesh, 34 surgeons agree that the mesh is conformable to the anatomy etc..</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Marking eases to place</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>conformability to the anatomy is useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absence of direction for positioning is useful</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prothesis Shape memory eases to place</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mesh transparency eases to place</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mesh easy to re-place</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The mesh does not twist during stapling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair</title>
        <description>Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh</description>
        <time_frame>Baseline Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surgical Approach</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
        </group_list>
        <measure>
          <title>The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair</title>
          <description>Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Open (Laparotomy)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Laparoscopy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Open then Laparoscopy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Use of Symbotex™ Composite Mesh and Surgery Duration</title>
        <description>Operative Time (min) for patients treated for ventral hernia</description>
        <time_frame>Baseline Day 0</time_frame>
        <population>3 approaches of surgery , thus operative time and hospital stay are provided according to the nature of the surgery the unit of Operative time is in minutes (specify in the title see below) And the unit of hospital stay is in days (speify in the title see below) Missing data on 4 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Operative Time (Min)</title>
            <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
          </group>
        </group_list>
        <measure>
          <title>The Use of Symbotex™ Composite Mesh and Surgery Duration</title>
          <description>Operative Time (min) for patients treated for ventral hernia</description>
          <population>3 approaches of surgery , thus operative time and hospital stay are provided according to the nature of the surgery the unit of Operative time is in minutes (specify in the title see below) And the unit of hospital stay is in days (speify in the title see below) Missing data on 4 patients.</population>
          <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="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Open (Laparotomy)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.4" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Laparoscopy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Open then Laparoscopy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.3" spread="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Use of Symbotex™ Composite Mesh and Hospital Stay Duration</title>
        <description>Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device</description>
        <time_frame>Baseline Day 0</time_frame>
        <population>For 8 patients there is 8 missing data respectively</population>
        <group_list>
          <group group_id="O1">
            <title>Hospital Stay ( Days)</title>
            <description>Hospital stay for patients treated for ventral hernia (Days)</description>
          </group>
        </group_list>
        <measure>
          <title>The Use of Symbotex™ Composite Mesh and Hospital Stay Duration</title>
          <description>Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device</description>
          <population>For 8 patients there is 8 missing data respectively</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Open (Laparotomy)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Laparoscopy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Symbotex Composite Mesh</title>
          <description>Symbotex™ Composite Mesh for ventral hernia repair by open or laparoscopic approach</description>
        </group>
      </group_list>
      <serious_events>
        <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="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="9" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Transitory ileus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS 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>
    <point_of_contact>
      <name_or_title>Djamila Bennat</name_or_title>
      <organization>Medtronic</organization>
      <phone>33474089000 ext 1591</phone>
      <email>djamila.bennat@medtronic.com</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/NCT02206828
org study id: COVSYMB0441
nct id: NCT02206828
lead sponsor: 
has dmc: Yes
The aim of this Observational Registry Study is to assess the short- and long-term clinical
      outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal
      wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use
      (IFU).
This is an observational multicenter registry study. One hundred consecutive, adult patients
      scheduled for primary and incisional abdominal wall hernia surgeries using Symbotex™
      Composite Mesh will be reported in the ClubHernie online database, with standard data
      captured of all preoperative, perioperative and post-operative data, for patient's outcomes
      measurements.

      Primary Objective:

      Evaluate the incidence of peri-operative and post-operative complications, with postoperative
      evaluations occurring, at discharge , 1 week (D1 and D8 follow up), 1 month (D30 follow up),
      1 year and 2 year follow up after primary and incisional abdominal wall hernia surgeries
      using Symbotex™ Composite Mesh by open or laparoscopic approach (such as anticipated device
      related complications such as pain, recurrence, complications related to adhesions, wound
      complications, other postoperative complications, (SAE).

      This online database consists of a systematic and consecutive data entry of all patients
      treated for Inguinal Hernia and Ventral Hernia by the 30 French surgeon members, with
      standard data captured of all preoperative, perioperative and post-operative data.

      The database is required to be completed anonymously. Quality data control of all data
      captured into the online database will be performed by coherence analysis by Club Hernie
      authorized representative;A statistical analysis plan will be developed by Covidien.

      Study reported device-related events will be reviewed periodically to assess for any
      potential trends
observational model: Cohort
time perspective: Prospective
measure: Incidence of Peri-operative and Post-operative Complications
time frame: Various (measured at 1 month, 1 Year & 2 Year)
description: Primary endpoint focuses on complications (including recurrence) occurring during procedure, and in short, mid and long-term (measured at 1 month, 1 year and 2 year follow-up respectively) following ventral hernia repair.
All peri-, intra- and post- operative complications
measure: Pain Assessment Measured With VAS Score
time frame: Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year
description: Pain assessment measured with VAS* score
*VAS: The postoperative pain is assessed using a 0-10 Visual Analogue Scale. Worst pain experienced over the last 24 hours. Mild pain for VAS score between 0 and 3; Moderate pain for VAS score > 3 and > 6 ; Severe pain for VAS scores > 6
measure: Quality of Life for Patient
time frame: Various ( 1 Month, 1 year and 2 Year follow up)
description: Quality of Life of patients treated for ventral hernia For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.
measure: Patient Satisfaction
time frame: Various (1 year and 2 year)
description: Patient satisfaction For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.
measure: Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)
time frame: Day 0 Baseline
description: Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia
measure: Mesh Handling
time frame: Day 0 Baseline
description: ease of use / mesh Handling Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia- Participant reflect surgeon who asses the feature of the mesh (for example, 68 surgeons agree that marking eases to place the mesh, 34 surgeons agree that the mesh is conformable to the anatomy etc..
measure: The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair
time frame: Baseline Day 0
description: Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh
measure: The Use of Symbotex™ Composite Mesh and Surgery Duration
time frame: Baseline Day 0
description: Operative Time (min) for patients treated for ventral hernia
measure: The Use of Symbotex™ Composite Mesh and Hospital Stay Duration
time frame: Baseline Day 0
description: Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device
arm group label: 1 GROUP
description: Only 1 group not predetermined
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-François Gillion
role: Principal Investigator
affiliation: ICMJE
facility: 
country: France
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Ventral
mesh term: Incisional Hernia
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 