<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/NCT04471311</url>
  </required_header>
  <id_info>
    <org_study_id>1872020</org_study_id>
    <nct_id>NCT04471311</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field.</brief_title>
  <acronym>Parthenope</acronym>
  <official_title>Safety and Efficacy of Prophylactic Resorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field: Protocol for a Multicenter Randomized Double Blind Prospected Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Sanitaria Locale Napoli 2 Nord</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Sanitaria Locale Napoli 2 Nord</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to analyse the feasibility, safety and IH rate using a&#xD;
      prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia&#xD;
      following midline laparotomy in clean-contaminated and contaminated wounds. The study was&#xD;
      designed as a double-blind randomized controlled trial comparing the running suture alone to&#xD;
      the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal&#xD;
      surgery causing significant morbidity and even mortality. The risk of developing an IH&#xD;
      following primary elective midline laparotomy is reported to be between 5 and 20 percent.&#xD;
      Risk factors for developing IH are both patient and surgery related. Patient factors include&#xD;
      diabetes, smoking, obesity, chronic corticosteroids use and connective tissue disorders,&#xD;
      comprised the presence of an Abdominal Aortic Aneurysm (AAA). Surgery related factors include&#xD;
      type of laparotomy, type of surgery, wounds classification, suture material used to close the&#xD;
      laparotomy and the suture length to wound length ratio (SL/WL).&#xD;
&#xD;
      In patients carrying AAA and/or obesity and/or contaminated wounds, incidence rises to 39%&#xD;
      (6,7). Besides the negative impact of incisional hernia regarding the patients' quality of&#xD;
      life, the direct costs of hernia repair and indirect cost of IH (sick leave) are an important&#xD;
      burden for the health care system.&#xD;
&#xD;
      Several groups investigated the role of prophylactic mesh placement in the prevention of IH&#xD;
      occurrence. A positive conclusion was reached by two systemic reviews. On the other side,&#xD;
      surgeons are mostly reluctant to implant permanent material in patients undergoing a&#xD;
      contaminated ventral hernia repair for the increased risk of postoperative infections, bowel&#xD;
      adhesions, mesh extrusion and/or erosion, fistula formation, seroma development and pain.&#xD;
&#xD;
      Recently, a retrospective study by Carbonell et al. investigated the feasibility and outcomes&#xD;
      of open ventral hernia repairs performed with a polypropylene mesh in the retro-rectus&#xD;
      position in clean-contaminated and contaminated fields, reporting a 30-day surgical site&#xD;
      infection rate of 7.1 and 19.0% respectively. The most appropriate mesh for hernia repair in&#xD;
      clean-contaminated and contaminated fields is not as clear .&#xD;
&#xD;
      Some other authors proposed the implant of Biological Meshes (BM) in contaminated and dirty&#xD;
      wounds, but their high costs limited their use. Moreover, data about long-term durability of&#xD;
      biologic grafts used in case of complex abdominal wall reconstruction are not clearly&#xD;
      defined. The so-called biosynthetic meshes (BSM) may, actually, offer advantages when&#xD;
      challenging with bacterial colonization during complex abdominal wall reconstruction.&#xD;
&#xD;
      The GORE BIO-A Tissue Reinforcement is a BSM composed of a bio-absorbable&#xD;
      polyglycolide-trimethylene carbonate copolymer, which is gradually absorbed by the body.&#xD;
&#xD;
      The aim of the present study is to analyse the feasibility, safety and IH rate using a&#xD;
      prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia&#xD;
      following midline laparotomy in clean-contaminated and contaminated wounds. The study was&#xD;
      designed as a double-blind randomized controlled trial comparing the running suture alone to&#xD;
      the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 1, 2022</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>
    <intervention_model_description>THIS IS A CONTROLLED RANDOMIZED STUDY OF BINARY SUPERIORITY OUTCOME IN PARALLEL GROUPS. 302 PATIENTS ARE REQUIRED TO HAVE A 95% CHANCE OF DETECTING, AS SIGNIFICANT AT THE 5% LEVEL, A DECREASE IN THE PRIMARY OUTCOME MEASURE FROM 18% (INCISIONAL HERNIA RATE) IN THE CONTROL GROUP TO 5%(INCISIONAL HERNIA RATE) IN THE EXPERIMENTAL GROUP.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Ultrasound examination</measure>
    <time_frame>3 months</time_frame>
    <description>Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Ultrasound examination</measure>
    <time_frame>6 months</time_frame>
    <description>Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Ultrasound examination</measure>
    <time_frame>12 months</time_frame>
    <description>Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Ultrasound examination</measure>
    <time_frame>24 months</time_frame>
    <description>Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Clinical examination</measure>
    <time_frame>3 months</time_frame>
    <description>Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Clinical examination</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Clinical examination</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Clinical examination</measure>
    <time_frame>24 months</time_frame>
    <description>Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients affected by Superficial surgical site infections</measure>
    <time_frame>Within 30 days postoperatively</time_frame>
    <description>Superficial infections according to Clavien-Dindo criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients affected by Deep surgical site infections</measure>
    <time_frame>Within 30 days postoperatively</time_frame>
    <description>Deep surgical site infections according to Clavien-Dindo criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">151</enrollment>
  <condition>Incisional Hernia After Midline Laparotomy</condition>
  <arm_group>
    <arm_group_label>Primary closure of midline laparotomy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Primary closure of midline laparotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-lay mesh supported closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sub-lay permanent mesh supported the closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sub-lay mesh supported closure</intervention_name>
    <description>A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, posterior layer is reinforced suturing the peritoneum and the posterior rectus sheath; below the arcuate line, the posterior layer is reinforced suturing the peritoneum and the trasversalis fascia. Anterior layer is re-established suturing the anterior rectus sheath. A 3 cm BIO-A Mesh strip is sutureless placed between the posterior rectus sheath and the rectus muscle with an overlap of 1,5 cm at each side. In laparotomies &gt;20 cm two stripes of 15 cm each is designed. The midline anterior rectus sheath is closed using a running slowly absorbable suture , covering the mesh.</description>
    <arm_group_label>Sub-lay mesh supported closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BIO-A (GORE) mesh</intervention_name>
    <description>3 cm BIO-A Mesh strip</description>
    <arm_group_label>Sub-lay mesh supported closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  Clean-contaminated, contaminated wounds • midline laparotomy &gt;10 cm&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years;&#xD;
&#xD;
          -  life expectancy &lt; 24 months (as estimated by the operating surgeon), - • pregnancy&#xD;
&#xD;
          -  immunosuppressant therapy within 2 weeks before surgery&#xD;
&#xD;
          -  clean and dirty wounds&#xD;
&#xD;
          -  wound length&lt;10 cm.&#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>Francesco Pizza</last_name>
    <role>Study Director</role>
    <affiliation>Azienda Sanitaria Locale Napoli 2 Nord</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francesco Pizza</last_name>
    <phone>3338275449</phone>
    <email>francesco_pizza@libero.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francesco Pizza</last_name>
    <email>francesco_pizza@libero.it</email>
  </overall_contact_backup>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Sanitaria Locale Napoli 2 Nord</investigator_affiliation>
    <investigator_full_name>Francesco Pizza</investigator_full_name>
    <investigator_title>Head of Bariatric Unit</investigator_title>
  </responsible_party>
  <keyword>Incisional Hernia</keyword>
  <keyword>Midline laparotomy</keyword>
  <keyword>Contaminated wound</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04471311
org study id: 1872020
nct id: NCT04471311
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to analyse the feasibility, safety and IH rate using a
      prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia
      following midline laparotomy in clean-contaminated and contaminated wounds. The study was
      designed as a double-blind randomized controlled trial comparing the running suture alone to
      the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal
      surgery causing significant morbidity and even mortality. The risk of developing an IH
      following primary elective midline laparotomy is reported to be between 5 and 20 percent.
      Risk factors for developing IH are both patient and surgery related. Patient factors include
      diabetes, smoking, obesity, chronic corticosteroids use and connective tissue disorders,
      comprised the presence of an Abdominal Aortic Aneurysm (AAA). Surgery related factors include
      type of laparotomy, type of surgery, wounds classification, suture material used to close the
      laparotomy and the suture length to wound length ratio (SL/WL).

      In patients carrying AAA and/or obesity and/or contaminated wounds, incidence rises to 39%
      (6,7). Besides the negative impact of incisional hernia regarding the patients' quality of
      life, the direct costs of hernia repair and indirect cost of IH (sick leave) are an important
      burden for the health care system.

      Several groups investigated the role of prophylactic mesh placement in the prevention of IH
      occurrence. A positive conclusion was reached by two systemic reviews. On the other side,
      surgeons are mostly reluctant to implant permanent material in patients undergoing a
      contaminated ventral hernia repair for the increased risk of postoperative infections, bowel
      adhesions, mesh extrusion and/or erosion, fistula formation, seroma development and pain.

      Recently, a retrospective study by Carbonell et al. investigated the feasibility and outcomes
      of open ventral hernia repairs performed with a polypropylene mesh in the retro-rectus
      position in clean-contaminated and contaminated fields, reporting a 30-day surgical site
      infection rate of 7.1 and 19.0% respectively. The most appropriate mesh for hernia repair in
      clean-contaminated and contaminated fields is not as clear .

      Some other authors proposed the implant of Biological Meshes (BM) in contaminated and dirty
      wounds, but their high costs limited their use. Moreover, data about long-term durability of
      biologic grafts used in case of complex abdominal wall reconstruction are not clearly
      defined. The so-called biosynthetic meshes (BSM) may, actually, offer advantages when
      challenging with bacterial colonization during complex abdominal wall reconstruction.

      The GORE BIO-A Tissue Reinforcement is a BSM composed of a bio-absorbable
      polyglycolide-trimethylene carbonate copolymer, which is gradually absorbed by the body.

      The aim of the present study is to analyse the feasibility, safety and IH rate using a
      prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia
      following midline laparotomy in clean-contaminated and contaminated wounds. The study was
      designed as a double-blind randomized controlled trial comparing the running suture alone to
      the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: THIS IS A CONTROLLED RANDOMIZED STUDY OF BINARY SUPERIORITY OUTCOME IN PARALLEL GROUPS. 302 PATIENTS ARE REQUIRED TO HAVE A 95% CHANCE OF DETECTING, AS SIGNIFICANT AT THE 5% LEVEL, A DECREASE IN THE PRIMARY OUTCOME MEASURE FROM 18% (INCISIONAL HERNIA RATE) IN THE CONTROL GROUP TO 5%(INCISIONAL HERNIA RATE) IN THE EXPERIMENTAL GROUP.
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Rate of Incisional Hernia at Ultrasound examination
time frame: 3 months
description: Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
measure: Rate of Incisional Hernia at Ultrasound examination
time frame: 6 months
description: Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
measure: Rate of Incisional Hernia at Ultrasound examination
time frame: 12 months
description: Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
measure: Rate of Incisional Hernia at Ultrasound examination
time frame: 24 months
description: Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
measure: Rate of Incisional Hernia at Clinical examination
time frame: 3 months
description: Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
measure: Rate of Incisional Hernia at Clinical examination
time frame: 6 months
description: Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
measure: Rate of Incisional Hernia at Clinical examination
time frame: 12 months
description: Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
measure: Rate of Incisional Hernia at Clinical examination
time frame: 24 months
description: Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
measure: Number of patients affected by Superficial surgical site infections
time frame: Within 30 days postoperatively
description: Superficial infections according to Clavien-Dindo criteria
measure: Number of patients affected by Deep surgical site infections
time frame: Within 30 days postoperatively
description: Deep surgical site infections according to Clavien-Dindo criteria
arm group label: Primary closure of midline laparotomy
arm group type: No Intervention
description: Primary closure of midline laparotomy
arm group label: Sub-lay mesh supported closure
arm group type: Experimental
description: Sub-lay permanent mesh supported the closure
intervention type: Procedure
intervention name: Sub-lay mesh supported closure
description: A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, posterior layer is reinforced suturing the peritoneum and the posterior rectus sheath; below the arcuate line, the posterior layer is reinforced suturing the peritoneum and the trasversalis fascia. Anterior layer is re-established suturing the anterior rectus sheath. A 3 cm BIO-A Mesh strip is sutureless placed between the posterior rectus sheath and the rectus muscle with an overlap of 1,5 cm at each side. In laparotomies >20 cm two stripes of 15 cm each is designed. The midline anterior rectus sheath is closed using a running slowly absorbable suture , covering the mesh.
arm group label: Sub-lay mesh supported closure
intervention type: Device
intervention name: BIO-A (GORE) mesh
description: 3 cm BIO-A Mesh strip
arm group label: Sub-lay mesh supported closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francesco Pizza
role: Study Director
affiliation: Azienda Sanitaria Locale Napoli 2 Nord
last name: Francesco Pizza
phone: 3338275449
email: francesco_pizza@libero.it
last name: Francesco Pizza
email: francesco_pizza@libero.it
responsible party type: Principal Investigator
investigator affiliation: Azienda Sanitaria Locale Napoli 2 Nord
investigator full name: Francesco Pizza
investigator title: Head of Bariatric Unit
mesh term: Hernia
mesh term: Incisional Hernia
sharing ipd: No