<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/NCT04436887</url>
  </required_header>
  <id_info>
    <org_study_id>11062018</org_study_id>
    <nct_id>NCT04436887</nct_id>
  </id_info>
  <brief_title>Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic Mesh Trial Evaluation UltraSound)</brief_title>
  <acronym>PROMETHEUS</acronym>
  <official_title>Prophylactic Sub-lay Non-absorbable Mesh Following Emergent Midline Laparotomy Clean/Contaminated Field: Early Results of a Randomized Double-blind Prospective Trial: PROMETHEUS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Francesco Pizza</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to analyse feasibility, safety and Incisional Hernia rate&#xD;
      using a prophylactic sub lay non-absorbable mesh [Parietex Progrip (Medtronic) ] in order to&#xD;
      prevent Incisional Hernia following midline emergent laparotomy in clean and&#xD;
      clean-contaminated wounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a double-blinded randomized trial, comparing the widely recommended midline&#xD;
      laparotomy closure using a running slowly absorbable suture to closure with the aid of a&#xD;
      permanent sub-lay mesh (Parietex Progrip), in patients undergoing midline laparotomy for&#xD;
      clean-contaminated surgery. From January 2016 to June 2018, a series of 200 patients were&#xD;
      included. All patients were operated in a single surgical Unit, located in Lacco Ameno&#xD;
      (Naples) at the only Hospital of the island. All patients undergoing 'open' midline&#xD;
      laparotomy for abdominal surgery in clean-contaminated fields were included. All patients&#xD;
      subscribed informed consent. Authorization was requested from the local regional Ethics&#xD;
      Committee. Exclusion criteria were: age &lt; 18 years; life expectancy &lt; 24 months (as estimated&#xD;
      by the operating surgeon), pregnancy, immunosuppressant therapy within 2 weeks before&#xD;
      surgery, clean, contaminated and dirty wounds, wound length&lt;10 cm. Patients were randomized&#xD;
      in two groups (Group A, receiving primary closure; Group B, receiving mesh supported closure&#xD;
      in a Sublay fashion). Randomization was obtained just before abdominal wall closure through&#xD;
      number (1 to 200) extraction by Operative room nurse (Even: Group A vs Odd: Group B). All&#xD;
      patients enrolled in the study were followed up sending a letter to their General&#xD;
      Practitioner. Outpatient clinic controls were done by surgeons/surgical residents/General&#xD;
      Practitioner blinded for the procedure.&#xD;
&#xD;
      Technical details Group A. Primary closure of midline laparotomy. The midline fascia is&#xD;
      closed using a double layer running slowly absorbable suture. Above arcuate line, the&#xD;
      posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate&#xD;
      line posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior&#xD;
      layer was performed suturing anterior rectus sheath. Suture length to wound length ratio of&#xD;
      4:1 as recommended (not routinely measured). Subcutaneous tissue and skin are closed&#xD;
      according to the first surgeon's preference.&#xD;
&#xD;
      Group B. Sub-lay mesh supported closure A 4 cm space is created between posterior rectus&#xD;
      sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath&#xD;
      edges are sutured using a running slowly absorbable suture. Above the arcuate line, the&#xD;
      posterior layer was performed suturing peritoneum and posterior rectus sheath; below the&#xD;
      arcuate line, the posterior layer was performed suturing peritoneum and trasversalis fascia.&#xD;
      The anterior layer was performed suturing anterior rectus sheath. A suture length to wound&#xD;
      length ratio of 4:1 is recommended (not routinely measured). A 4-cm Parietex Progrip Mesh&#xD;
      strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at&#xD;
      least 2 cm at each side, sutureless. The not gripping face of the mesh was positioned on the&#xD;
      posterior rectal sheat to allow the muscle to become in contact with the grips. In&#xD;
      laparotomies &gt;20 cm two stripes of 15 cm each were designed. The midline anterior rectus&#xD;
      sheath was closed using a running slowly absorbable suture covering the mesh. A suture length&#xD;
      to wound length ratio of 4:1 is recommended (not routinely measured). Subcutaneous tissue and&#xD;
      skin closure were up to the surgeon preference.&#xD;
&#xD;
      Endpoints Primary endpoint was Incisional Hernia rate. Patients were postoperatively examined&#xD;
      at 3, 6, 12 and 24 months. Both clinical examination and ultrasound imaging were performed in&#xD;
      all patients at follow-up. Physicians were blind about which Group (A or B) the patients had&#xD;
      been placed. Incisional Hernia was clinically defined as any visible or palpable ''blowout''&#xD;
      in the midline abdominal scar. At 3, 6, 12 and 24 months ultrasound imaging was performed to&#xD;
      examine the midline for all patients with symptomatic or asymptomatic, providing any valuable&#xD;
      information about Incisional Hernia onset. Size and location of all ultrasound detected&#xD;
      Incisional Hernia were registered, as well as any other patient's complaint. The ultrasonic&#xD;
      criteria of Incisional Hernia were a visible gap within the abdominal wall and/or ''tissue&#xD;
      moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''.&#xD;
      Incisional Hernia was diagnosed if clinical criteria and/or ultrasound criteria were&#xD;
      fulfilled. The study was not designed to discriminate single or multiple defects. The study&#xD;
      will be completed at 2 years' follow up. Secondary endpoints included the incidence of wound&#xD;
      events. Wound events were classified as surgical site infections according to Clavien Dindo&#xD;
      criteria (superficial, deep or organ space). Surgical site events were reported according to&#xD;
      the Ventral Hernia Working Group definitions. Actions for wound events were categorized as&#xD;
      follows: antibiotics only, bedside wound interventions, percutaneous manoeuvres or surgical&#xD;
      debridement.&#xD;
&#xD;
      Blinding Process&#xD;
&#xD;
      Patients, care providers, staff collecting data, and those assessing the endpoints were all&#xD;
      blinded to treatment allocation. Patients were blinded to the surgical procedure performed&#xD;
      until the final assessment of the study endpoints. Because the blinding of the operating&#xD;
      surgeons was not feasible, they were not involved in the data collection and outcome&#xD;
      assessment. Physicians in charge of patients' management were not involved in the operating&#xD;
      room and were blinded to the intervention. The data were collected and analyzed by physicians&#xD;
      who were not involved in the patient's management during the whole Randomized trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>Sample size: Considering a mean percentage of incidence of Incisional Hernia of 20% in the open middle line laparotomy in the clean-contemned setting. We hypothesized that Incisional Hernia rate in Group B (Experimental Group) would be superior to Group A (control group) if the difference in a mean percentage of incidence of Incisional Hernia was less than 15%. 194 patients are required to have a 90% chance of detecting, as significant at the 5% level, a decrease in the primary outcome measure from 20% in the control group to 5% in the experimental group. Baseline comparisons were performed using chi-square tests and T-tests. Continuous variables are expressed as mean ± standard deviation (SD). Differences between preoperative and postoperative parameters were compared by Wilcoxon paired rank test. For all tests, a two-sided p&lt;0.05 was considered statistically significant. The study designed with Sealed Envelope.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Blinding Process&#xD;
Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to treatment allocation. Patients were blinded to the surgical procedure performed until the final assessment of the study endpoints. Because the blinding of the operating surgeons was not feasible, they were not involved in the data collection and outcome assessment. Physicians in charge of patients' management were not involved in the operating room and were blinded to the intervention. The data were collected and analyzed by physicians who were not involved in the patient's management during the whole Randomized Controlled Trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Clinical examination</measure>
    <time_frame>Patients are postoperatively examined at 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>Patients are postoperatively examined at 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>Patients are postoperatively examined at 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>Patients are postoperatively examined at 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>
  <primary_outcome>
    <measure>Rate of Incisional Hernia at Ultrasound examination</measure>
    <time_frame>Patients are postoperatively examined at 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>Patients are postoperatively examined at 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>Patients are postoperatively examined at 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>Patients are postoperatively examined at 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>
  <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="Actual">200</enrollment>
  <condition>Incisional Hernia</condition>
  <condition>Wound Infection</condition>
  <arm_group>
    <arm_group_label>Primary closure</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>Mesh 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>positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia</intervention_name>
    <description>Sub-lay mesh supported closure 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 arcuate line, posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate line, posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior layer was performed suturing anterior rectus sheath. A suture length to wound length ratio of 4:1 is recommended. A 4-cm Parietex Progrip Mesh strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at least 2 cm at each side, suture less. In laparotomies &gt;20 cm two stripes of 15 cm each were designed. The midline anterior rectus sheath was closed using a running slowly absorbable suture, covering the mesh. A suture length to wound length ratio of 4:1 is recommended.</description>
    <arm_group_label>Mesh closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  Clean-contaminated wounds&#xD;
&#xD;
          -  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), -&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  immunosuppressant therapy within 2 weeks before surgery&#xD;
&#xD;
          -  clean, contaminated 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>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</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/NCT04436887
org study id: 11062018
nct id: NCT04436887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the present study is to analyse feasibility, safety and Incisional Hernia rate
      using a prophylactic sub lay non-absorbable mesh [Parietex Progrip (Medtronic) ] in order to
      prevent Incisional Hernia following midline emergent laparotomy in clean and
      clean-contaminated wounds.
The study is a double-blinded randomized trial, comparing the widely recommended midline
      laparotomy closure using a running slowly absorbable suture to closure with the aid of a
      permanent sub-lay mesh (Parietex Progrip), in patients undergoing midline laparotomy for
      clean-contaminated surgery. From January 2016 to June 2018, a series of 200 patients were
      included. All patients were operated in a single surgical Unit, located in Lacco Ameno
      (Naples) at the only Hospital of the island. All patients undergoing 'open' midline
      laparotomy for abdominal surgery in clean-contaminated fields were included. All patients
      subscribed informed consent. Authorization was requested from the local regional Ethics
      Committee. Exclusion criteria were: age < 18 years; life expectancy < 24 months (as estimated
      by the operating surgeon), pregnancy, immunosuppressant therapy within 2 weeks before
      surgery, clean, contaminated and dirty wounds, wound length<10 cm. Patients were randomized
      in two groups (Group A, receiving primary closure; Group B, receiving mesh supported closure
      in a Sublay fashion). Randomization was obtained just before abdominal wall closure through
      number (1 to 200) extraction by Operative room nurse (Even: Group A vs Odd: Group B). All
      patients enrolled in the study were followed up sending a letter to their General
      Practitioner. Outpatient clinic controls were done by surgeons/surgical residents/General
      Practitioner blinded for the procedure.

      Technical details Group A. Primary closure of midline laparotomy. The midline fascia is
      closed using a double layer running slowly absorbable suture. Above arcuate line, the
      posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate
      line posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior
      layer was performed suturing anterior rectus sheath. Suture length to wound length ratio of
      4:1 as recommended (not routinely measured). Subcutaneous tissue and skin are closed
      according to the first surgeon's preference.

      Group B. Sub-lay mesh supported closure 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, the
      posterior layer was performed suturing peritoneum and posterior rectus sheath; below the
      arcuate line, the posterior layer was performed suturing peritoneum and trasversalis fascia.
      The anterior layer was performed suturing anterior rectus sheath. A suture length to wound
      length ratio of 4:1 is recommended (not routinely measured). A 4-cm Parietex Progrip Mesh
      strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at
      least 2 cm at each side, sutureless. The not gripping face of the mesh was positioned on the
      posterior rectal sheat to allow the muscle to become in contact with the grips. In
      laparotomies >20 cm two stripes of 15 cm each were designed. The midline anterior rectus
      sheath was closed using a running slowly absorbable suture covering the mesh. A suture length
      to wound length ratio of 4:1 is recommended (not routinely measured). Subcutaneous tissue and
      skin closure were up to the surgeon preference.

      Endpoints Primary endpoint was Incisional Hernia rate. Patients were postoperatively examined
      at 3, 6, 12 and 24 months. Both clinical examination and ultrasound imaging were performed in
      all patients at follow-up. Physicians were blind about which Group (A or B) the patients had
      been placed. Incisional Hernia was clinically defined as any visible or palpable ''blowout''
      in the midline abdominal scar. At 3, 6, 12 and 24 months ultrasound imaging was 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 were registered, as well as any other patient's complaint. The ultrasonic
      criteria of Incisional Hernia were 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 was diagnosed if clinical criteria and/or ultrasound criteria were
      fulfilled. The study was not designed to discriminate single or multiple defects. The study
      will be completed at 2 years' follow up. Secondary endpoints included the incidence of wound
      events. Wound events were classified as surgical site infections according to Clavien Dindo
      criteria (superficial, deep or organ space). Surgical site events were reported according to
      the Ventral Hernia Working Group definitions. Actions for wound events were categorized as
      follows: antibiotics only, bedside wound interventions, percutaneous manoeuvres or surgical
      debridement.

      Blinding Process

      Patients, care providers, staff collecting data, and those assessing the endpoints were all
      blinded to treatment allocation. Patients were blinded to the surgical procedure performed
      until the final assessment of the study endpoints. Because the blinding of the operating
      surgeons was not feasible, they were not involved in the data collection and outcome
      assessment. Physicians in charge of patients' management were not involved in the operating
      room and were blinded to the intervention. The data were collected and analyzed by physicians
      who were not involved in the patient's management during the whole Randomized trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Sample size: Considering a mean percentage of incidence of Incisional Hernia of 20% in the open middle line laparotomy in the clean-contemned setting. We hypothesized that Incisional Hernia rate in Group B (Experimental Group) would be superior to Group A (control group) if the difference in a mean percentage of incidence of Incisional Hernia was less than 15%. 194 patients are required to have a 90% chance of detecting, as significant at the 5% level, a decrease in the primary outcome measure from 20% in the control group to 5% in the experimental group. Baseline comparisons were performed using chi-square tests and T-tests. Continuous variables are expressed as mean ± standard deviation (SD). Differences between preoperative and postoperative parameters were compared by Wilcoxon paired rank test. For all tests, a two-sided p<0.05 was considered statistically significant. The study designed with Sealed Envelope.
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: Blinding Process
Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to treatment allocation. Patients were blinded to the surgical procedure performed until the final assessment of the study endpoints. Because the blinding of the operating surgeons was not feasible, they were not involved in the data collection and outcome assessment. Physicians in charge of patients' management were not involved in the operating room and were blinded to the intervention. The data were collected and analyzed by physicians who were not involved in the patient's management during the whole Randomized Controlled Trial.
measure: Rate of Incisional Hernia at Clinical examination
time frame: Patients are postoperatively examined at 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: Patients are postoperatively examined at 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: Patients are postoperatively examined at 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: Patients are postoperatively examined at 24 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 Ultrasound examination
time frame: Patients are postoperatively examined at 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: Patients are postoperatively examined at 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: Patients are postoperatively examined at 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: Patients are postoperatively examined at 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: 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
arm group type: No Intervention
description: Primary closure of midline laparotomy
arm group label: Mesh closure
arm group type: Experimental
description: Sub-lay permanent mesh supported the closure
intervention type: Procedure
intervention name: positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia
description: Sub-lay mesh supported closure 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 arcuate line, posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate line, posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior layer was performed suturing anterior rectus sheath. A suture length to wound length ratio of 4:1 is recommended. A 4-cm Parietex Progrip Mesh strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at least 2 cm at each side, suture less. In laparotomies >20 cm two stripes of 15 cm each were designed. The midline anterior rectus sheath was closed using a running slowly absorbable suture, covering the mesh. A suture length to wound length ratio of 4:1 is recommended.
arm group label: Mesh closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Azienda Sanitaria Locale Napoli 2 Nord
investigator full name: Francesco Pizza
investigator title: Head of bariatric unit
mesh term: Wound Infection
mesh term: Incisional Hernia
sharing ipd: No