<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/NCT01673568</url>
  </required_header>
  <id_info>
    <org_study_id>AB-BINDER</org_study_id>
    <nct_id>NCT01673568</nct_id>
  </id_info>
  <brief_title>Abdominal Binder to Reduce Pain and Seroma Formation</brief_title>
  <acronym>ABD- BINDER</acronym>
  <official_title>Postoperative Abdominal Binder in Reducing Seroma Formation and Pain After Ventral (Umbi/Epi) Hernia Repair.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Copenhagen University Hospital at Herlev</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative seroma formation is one of the most common complications after ventral hernia&#xD;
      repair. Although some seromas may not have clinical impact, postoperative seroma formation&#xD;
      often causes pain and discomfort and may even compromise wound healing. The use of&#xD;
      postoperative abdominal binder is often recommended after ventral hernia repair to prevent&#xD;
      seroma and diminish pain, but still with no scientific evidence. The primary aim of the&#xD;
      present study is to investigate the effect of postoperative abdominal binders after&#xD;
      laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life.&#xD;
      Secondary, we register seroma formation.&#xD;
&#xD;
      Method and material Randomized, controlled, multi-center, investigator-blinded study. A&#xD;
      minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power&#xD;
      calculations. Patients are randomized either to abdominal binder or no abdominal binder. The&#xD;
      abdominal binder is worn from immediately after the operation and continuously for 7 days,&#xD;
      night and day. Outcomes are based on patient self-reported registrations using Visual Analog&#xD;
      Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to&#xD;
      estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For&#xD;
      secondary outcome we use ultrasound to measure the volume of seroma formation. We use&#xD;
      Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test&#xD;
      for pain, discomfort and quality of life for the effect of time on inter- and intragroup&#xD;
      differences during the study period. P &lt; 0.05 is considered significant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative seroma formation is one of the most common complications after ventral hernia&#xD;
      repair. Although some seromas may not have clinical impact postoperative seroma formation&#xD;
      often causes pain and discomfort and may even compromise wound healing. Several&#xD;
      interventional procedures have been investigated to reduce or avoid postoperative seroma&#xD;
      formation such as removal of the hernia sac, VAC (vacuum-assisted closure) therapy, talcum&#xD;
      application to the subcutaneous layer, suction etc., but results are conflicting and evidence&#xD;
      is of poor quality. The use of postoperative abdominal binder is often recommended after&#xD;
      ventral hernia repair to prevent seroma and diminish pain, but still with no scientific&#xD;
      evidence. Randomized, controlled, multi-center, investigator-blinded study supplemented with&#xD;
      blinded statistical analysis (see below). 56 patients (2 x 28, umbi/epi) Due to power&#xD;
      calculations. An intention to treat analysis is done. Patients are randomized either to&#xD;
      abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after&#xD;
      the operation and continuously for 7 days, night and day. The belts are standard elastic&#xD;
      belts (ostomy belts) from &quot;ETO garments©&quot; with standard height of 22 cm. and five different&#xD;
      sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before&#xD;
      the operation by waist measurement according to the recommendation from the company. Patients&#xD;
      are followed-up for 30 days with clinical follow-up at day 7 and 30.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale of Pain Activity</measure>
    <time_frame>24 hours after hernia repair</time_frame>
    <description>Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroma Formation</measure>
    <time_frame>postoperative day 7</time_frame>
    <description>Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Ventral Hernias</condition>
  <arm_group>
    <arm_group_label>abdominal binder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from &quot;ETO garments©&quot; with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no abdominal binder</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no abdominal binder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ETO garments</intervention_name>
    <description>patients wearing abdominal binder for 7 days postoperatively</description>
    <arm_group_label>abdominal binder</arm_group_label>
    <other_name>longuette</other_name>
    <other_name>ostomy belt</other_name>
    <other_name>trusses</other_name>
    <other_name>girdle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective, primary and recurrent laparoscopic umbilical and epigastric hernia repair&#xD;
             with mesh reinforcement&#xD;
&#xD;
          -  Fascia defects 2-8 cm measured preoperatively by the surgeon at the out-patient clinic&#xD;
             for umbi/epi&#xD;
&#xD;
          -  Elective, primary and recurrent laparoscopic trocar-site hernia&#xD;
&#xD;
          -  Patients between 18-80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open ventral hernia repair&#xD;
&#xD;
          -  Expected low compliance (language problems, dementia and abuse etc.)&#xD;
&#xD;
          -  Fascia defects &gt;8 cm at the preoperative clinical examination.&#xD;
&#xD;
          -  Acute operation&#xD;
&#xD;
          -  Chronic pain syndrome&#xD;
&#xD;
          -  Decompensated liver cirrhosis (Child-Pugh B-C)&#xD;
&#xD;
          -  Patients with a stoma&#xD;
&#xD;
          -  If a secondary operation is performed during the hernia repair procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thue Bisgaard, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital HVidovre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <state>CPH</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>July 4, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>February 18, 2014</results_first_submitted>
  <results_first_submitted_qc>May 21, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 9, 2014</results_first_posted>
  <last_update_submitted>May 21, 2014</last_update_submitted>
  <last_update_submitted_qc>May 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Mette Willaume Christoffersen</investigator_full_name>
    <investigator_title>MD, PhD. stud.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Abdominal Binder</title>
          <description>The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from &quot;ETO garments©&quot; with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.&#xD;
ETO garments: patients wearing abdominal binder for 7 days postoperatively</description>
        </group>
        <group group_id="P2">
          <title>no Abdominal Binder</title>
          <description>no abdominal binder</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </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>
      <population>patiens were median 51 years, gender M:F=22:6.</population>
      <group_list>
        <group group_id="B1">
          <title>Abdominal Binder</title>
          <description>The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from &quot;ETO garments©&quot; with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.&#xD;
ETO garments: patients wearing abdominal binder for 7 days postoperatively</description>
        </group>
        <group group_id="B2">
          <title>no Abdominal Binder</title>
          <description>no abdominal binder was warn</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="28"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51" lower_limit="21" upper_limit="73"/>
                    <measurement group_id="B2" value="51" lower_limit="31" upper_limit="71"/>
                    <measurement group_id="B3" value="51" lower_limit="21" upper_limit="73"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale of Pain Activity</title>
        <description>Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.</description>
        <time_frame>24 hours after hernia repair</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abdominal Binder</title>
            <description>The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from &quot;ETO garments©&quot; with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.&#xD;
ETO garments: patients wearing abdominal binder for 7 days postoperatively</description>
          </group>
          <group group_id="O2">
            <title>no Abdominal Binder</title>
            <description>no abdominal binder</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale of Pain Activity</title>
          <description>Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="13" upper_limit="100"/>
                    <measurement group_id="O2" value="70" lower_limit="11" upper_limit="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroma Formation</title>
        <description>Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.</description>
        <time_frame>postoperative day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abdominal Binder</title>
            <description>The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from &quot;ETO garments©&quot; with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.&#xD;
ETO garments: patients wearing abdominal binder for 7 days postoperatively</description>
          </group>
          <group group_id="O2">
            <title>no Abdominal Binder</title>
            <description>no abdominal binder</description>
          </group>
        </group_list>
        <measure>
          <title>Seroma Formation</title>
          <description>Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.</description>
          <units>mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="0" upper_limit="300"/>
                    <measurement group_id="O2" value="9" lower_limit="0" upper_limit="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Abdominal Binder</title>
          <description>The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from &quot;ETO garments©&quot; with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.&#xD;
ETO garments: patients wearing abdominal binder for 7 days postoperatively</description>
        </group>
        <group group_id="E2">
          <title>no Abdominal Binder</title>
          <description>no abdominal binder</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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 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>
    <point_of_contact>
      <name_or_title>Mette W. Christoffersen</name_or_title>
      <organization>Hvidovre Hospital University of Copenhagen</organization>
      <phone>38625826</phone>
      <email>mette.willaume@gmail.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/NCT01673568
org study id: AB-BINDER
nct id: NCT01673568
lead sponsor: 
collaborator: 
has dmc: No
Postoperative seroma formation is one of the most common complications after ventral hernia
      repair. Although some seromas may not have clinical impact, postoperative seroma formation
      often causes pain and discomfort and may even compromise wound healing. The use of
      postoperative abdominal binder is often recommended after ventral hernia repair to prevent
      seroma and diminish pain, but still with no scientific evidence. The primary aim of the
      present study is to investigate the effect of postoperative abdominal binders after
      laparoscopic ventral hernia repair on postoperative pain, discomfort and quality of life.
      Secondary, we register seroma formation.

      Method and material Randomized, controlled, multi-center, investigator-blinded study. A
      minimum of 56 patients (2X28 umbi/epi) are included, inclusion number is based on power
      calculations. Patients are randomized either to abdominal binder or no abdominal binder. The
      abdominal binder is worn from immediately after the operation and continuously for 7 days,
      night and day. Outcomes are based on patient self-reported registrations using Visual Analog
      Scales (VAS) and Carolina Comfort Scale (CCS), which is a validated, hernia-specific tool to
      estimate quality of life, pain and discomfort. Patients are followed-up for 30 days. For
      secondary outcome we use ultrasound to measure the volume of seroma formation. We use
      Mann-Witney, non-parametric statistics calculating the seroma formation and Friedmanns test
      for pain, discomfort and quality of life for the effect of time on inter- and intragroup
      differences during the study period. P < 0.05 is considered significant.
Postoperative seroma formation is one of the most common complications after ventral hernia
      repair. Although some seromas may not have clinical impact postoperative seroma formation
      often causes pain and discomfort and may even compromise wound healing. Several
      interventional procedures have been investigated to reduce or avoid postoperative seroma
      formation such as removal of the hernia sac, VAC (vacuum-assisted closure) therapy, talcum
      application to the subcutaneous layer, suction etc., but results are conflicting and evidence
      is of poor quality. The use of postoperative abdominal binder is often recommended after
      ventral hernia repair to prevent seroma and diminish pain, but still with no scientific
      evidence. Randomized, controlled, multi-center, investigator-blinded study supplemented with
      blinded statistical analysis (see below). 56 patients (2 x 28, umbi/epi) Due to power
      calculations. An intention to treat analysis is done. Patients are randomized either to
      abdominal binder or no abdominal binder. The abdominal binder is worn from immediately after
      the operation and continuously for 7 days, night and day. The belts are standard elastic
      belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different
      sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before
      the operation by waist measurement according to the recommendation from the company. Patients
      are followed-up for 30 days with clinical follow-up at day 7 and 30.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Visual Analog Scale of Pain Activity
time frame: 24 hours after hernia repair
description: Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.
measure: Seroma Formation
time frame: postoperative day 7
description: Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.
arm group label: abdominal binder
arm group type: Active Comparator
description: The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from "ETO garments©" with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.
arm group label: no abdominal binder
arm group type: No Intervention
description: no abdominal binder
intervention type: Device
intervention name: ETO garments
description: patients wearing abdominal binder for 7 days postoperatively
arm group label: abdominal binder
other name: longuette
other name: ostomy belt
other name: trusses
other name: girdle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Thue Bisgaard, MD
role: Study Director
affiliation: University Hospital HVidovre
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Mette Willaume Christoffersen
investigator title: MD, PhD. stud.
mesh term: Hernia
mesh term: Hernia, Ventral
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 