<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/NCT02208557</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)220/2013</org_study_id>
    <nct_id>NCT02208557</nct_id>
  </id_info>
  <brief_title>Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy</brief_title>
  <acronym>PREBIOUS</acronym>
  <official_title>PREBIOUS Trial : A Multicenter Randomized Controlled Trial of Preventive Midline Laparotomy Closure With a Bioabsorbable Mesh for the Prevention of Incisional Hernia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Development of an incisional hernia is one of the most frequent complications of&#xD;
      midline laparotomies requiring reoperation. This paper presents the rationale, design, and&#xD;
      study protocol for a randomized controlled trial, the aim of which was to evaluate the&#xD;
      efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for&#xD;
      reinforcement of a midline fascial closure.&#xD;
&#xD;
      Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh)&#xD;
      is a multicenter randomized controlled trial in which adult patients undergoing elective or&#xD;
      urgent open abdominal operations through a midline laparotomy incision are assigned to one of&#xD;
      two groups based on the laparotomy closure procedure: an intervention group in which a&#xD;
      continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE®&#xD;
      BIO-A® Tissue Reinforcement prosthesis (W. L. Gore &amp; Associates, Flagstaff, Arizona, USA), or&#xD;
      a control group with continuous PDS suture only. Both groups are followed over 6 months.&#xD;
&#xD;
      Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical&#xD;
      examination at clinical visits and radiologically (CT scan) performed at the end of&#xD;
      follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma,&#xD;
      burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate&#xD;
      that suture plus prosthetic mesh insertion for routine midline laparotomy closure is&#xD;
      effective in preventing incisional hernias after open abdominal surgery, to avoid the effects&#xD;
      on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life,&#xD;
      and to save costs potentially associated with incisional hernia surgical repair.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of incisional hernia</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 6 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative complications</measure>
    <time_frame>30 days</time_frame>
    <description>Secondary endpoints are perioperative complications, including wound infection, hematoma, eventration, pain, reoperation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">488</enrollment>
  <condition>Incisional Hernia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparotomy closure will be done by continuous PDS suture following a SL:WL ratio of 4:1 only is used for midline laparotomy closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reinforcement with Absorbable Mesh</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Closure of the midline laparotomy incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore &amp; Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a &quot;sandwich&quot; method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Reinforcement with Absorbable Mesh</intervention_name>
    <arm_group_label>Reinforcement with Absorbable Mesh</arm_group_label>
    <other_name>GORE® BIO-A® Tissue Reinforcement prosthesis</other_name>
    <other_name>(W. L. Gore &amp; Associates, Flagstaff, Arizona, USA) mesh.</other_name>
    <other_name>LNE/G-MED (CE) 0459</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Control CT</intervention_name>
    <description>At the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest.&#xD;
The radiologist is blinded to the patient's history and the technique used for midline fascial closure.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Reinforcement with Absorbable Mesh</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Follow Up</intervention_name>
    <description>The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Reinforcement with Absorbable Mesh</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years or older,&#xD;
&#xD;
          -  Signed informed consent,&#xD;
&#xD;
          -  Patients undergoing elective or urgent open abdominal surgical procedures regardless&#xD;
             of benign or malignant disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of primary or recurrent incisional hernia&#xD;
&#xD;
          -  Expected survival &lt; 12 months.&#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>Manuel Lopez-Cano, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitari Vall d´Hebrón</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manuel Lopez-Cano, MD, PhD</last_name>
    <phone>+34 - 932746000</phone>
    <phone_ext>6587</phone_ext>
    <email>mlpezcano@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital de Igualada</name>
      <address>
        <city>Igualada</city>
        <state>Barcelona</state>
        <zip>08700</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier Feliú, MD, PhD</last_name>
      <email>16255xfp@comb.cat</email>
    </contact>
    <investigator>
      <last_name>Xavier Feliú, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salvador Navarro, MD, PhD</last_name>
      <email>snavarro@tauli.cat</email>
    </contact>
    <investigator>
      <last_name>Salvador Navarro, MD,PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Sagunto</name>
      <address>
        <city>Sagunto</city>
        <state>Valencia</state>
        <zip>46520</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Lozoya, MD, PhD</last_name>
      <email>rlozoya@aecirujanos.es</email>
    </contact>
    <investigator>
      <last_name>Roberto Lozoya, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar, Parc de Salut Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Antonio Pereira, Md, PhD</last_name>
      <email>japerneira@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jose Antonio Pereira, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Lopez-Cano, MD, PhD</last_name>
      <phone>+34 - 93274600</phone>
      <phone_ext>6587</phone_ext>
      <email>mlpezcano@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Manuel Lopez-Cano, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Lerida</city>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafael Villalobos, MD</last_name>
      <email>rafovilla26@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Rafael Villalobos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>May 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 3, 2014</last_update_submitted>
  <last_update_submitted_qc>August 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Incisional hernia</keyword>
  <keyword>prevention</keyword>
  <keyword>laparotomy closure</keyword>
  <keyword>absorbable mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02208557
org study id: PR(AG)220/2013
nct id: NCT02208557
lead sponsor: 
has dmc: No
Background: Development of an incisional hernia is one of the most frequent complications of
      midline laparotomies requiring reoperation. This paper presents the rationale, design, and
      study protocol for a randomized controlled trial, the aim of which was to evaluate the
      efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for
      reinforcement of a midline fascial closure.

      Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh)
      is a multicenter randomized controlled trial in which adult patients undergoing elective or
      urgent open abdominal operations through a midline laparotomy incision are assigned to one of
      two groups based on the laparotomy closure procedure: an intervention group in which a
      continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE®
      BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA), or
      a control group with continuous PDS suture only. Both groups are followed over 6 months.

      Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical
      examination at clinical visits and radiologically (CT scan) performed at the end of
      follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma,
      burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate
      that suture plus prosthetic mesh insertion for routine midline laparotomy closure is
      effective in preventing incisional hernias after open abdominal surgery, to avoid the effects
      on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life,
      and to save costs potentially associated with incisional hernia surgical repair.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of incisional hernia
time frame: 6 months
description: The primary endpoint is the incidence of incisional hernia, either symptomatic or asymptomatic in the mesh and suture-only groups. Because appearance of an incisional hernia occurs within the first months after laparotomy, assessment of efficacy was carried out during scheduled clinical visits over a period of 6 months. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 months after operation).
measure: Perioperative complications
time frame: 30 days
description: Secondary endpoints are perioperative complications, including wound infection, hematoma, eventration, pain, reoperation.
arm group label: Control
arm group type: Active Comparator
description: Laparotomy closure will be done by continuous PDS suture following a SL:WL ratio of 4:1 only is used for midline laparotomy closure.
arm group label: Reinforcement with Absorbable Mesh
arm group type: Experimental
description: Closure of the midline laparotomy incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.
intervention type: Procedure
intervention name: Reinforcement with Absorbable Mesh
arm group label: Reinforcement with Absorbable Mesh
other name: GORE® BIO-A® Tissue Reinforcement prosthesis
other name: (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh.
other name: LNE/G-MED (CE) 0459
intervention type: Radiation
intervention name: Control CT
description: At the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest.
The radiologist is blinded to the patient's history and the technique used for midline fascial closure.
arm group label: Control
arm group label: Reinforcement with Absorbable Mesh
intervention type: Other
intervention name: Clinical Follow Up
description: The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
arm group label: Control
arm group label: Reinforcement with Absorbable Mesh
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manuel Lopez-Cano, MD, PhD
role: Principal Investigator
affiliation: Hospital Universitari Vall d´Hebrón
last name: Manuel Lopez-Cano, MD, PhD
phone: +34 - 932746000
phone ext: 6587
email: mlpezcano@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Hernia
mesh term: Incisional Hernia