<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/NCT03283982</url>
  </required_header>
  <id_info>
    <org_study_id>17-1053</org_study_id>
    <nct_id>NCT03283982</nct_id>
  </id_info>
  <brief_title>Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM</brief_title>
  <official_title>Registry-Based, Prospective, Single-Blind, Randomized Controlled Trial: Robotic vs. Laparoscopic Ventral Hernia Repair With Intraperitoneal Onlay Mesh (IPOM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Intuitive Surgical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to conduct a registry-based, randomized controlled trial to investigate&#xD;
      if the robotic platform for minimally invasive ventral hernia repair with intraperitoneal&#xD;
      onlay mesh (IPOM), when compared to the laparoscopic platform, will influence on early&#xD;
      postoperative pain scores, wound morbidity (surgical site infections, surgical site&#xD;
      occurrences and surgical site occurrences requiring procedural intervention), ventral hernia&#xD;
      recurrence rate and abdominal wall-specific quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the adoption of the robotic platform for ventral hernia repair, there is still a&#xD;
      paucity of literature to speak to the benefits of this approach. In a recently-published&#xD;
      propensity score analysis comparing laparoscopic and robotic ventral hernia repairs with&#xD;
      intraperitoneal onlay mesh (IPOM) , the authors showed a 1-day decrease in hospital length of&#xD;
      stay (LOS) with the robotic versus laparoscopic platform for laparoscopic ventral hernia&#xD;
      repair with IPOM. The reasons for this decrease in stay remain unknown. While multiple papers&#xD;
      have described postoperative pain scores following laparoscopic ventral hernia repair, scant&#xD;
      data exists evaluating postoperative pain following robotic ventral hernia repair. To help&#xD;
      determine if the robotic platform has an impact on postoperative pain, wound morbidity rates,&#xD;
      ventral hernia recurrence and quality of life, the investigators propose a registry-based,&#xD;
      randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative&#xD;
      (AHSQC). The AHSQC is a multicenter, nationwide quality improvement effort with a mission to&#xD;
      improve value in hernia care. Data are collected prospectively in the routine care of hernia&#xD;
      patients for quality improvement purposes. The information collected in the AHSQC offers a&#xD;
      natural repository of information that can be used for research, in addition to its quality&#xD;
      improvement purpose. The investigators aim to conduct a prospective, registry-based,&#xD;
      single-blind, randomized controlled trial with a 1:1 allocation ratio. This will be a&#xD;
      single-institutional study performed at the Cleveland Clinic Foundation in Cleveland, Ohio&#xD;
      from 2017 to 2020. All enrollments and surgeries in this study will take place at the&#xD;
      Cleveland Clinic Comprehensive Hernia Center. The study will consist of 2 interventions:&#xD;
      laparoscopic IPOM or robotic IPOM. Participants will be randomized to laparoscopic ventral&#xD;
      hernia repair with IPOM or robotic ventral hernia repair with IPOM at the moment of&#xD;
      enrollment, during preoperative evaluation. Participants will be blinded to the intervention.&#xD;
      Both the laparoscopic and robotic platforms represent current standards of care for ventral&#xD;
      hernia repair, and both approaches are currently offered at Cleveland Clinic Comprehensive&#xD;
      Hernia Center. The sample size was determined by the primary outcome of interest, the change&#xD;
      in NRS-11 pain score at postoperative day 1. The investigators hypothesize that the robotic&#xD;
      approach will be associated with a 30% decrease in NRS-11 pain score at postoperative day 1.&#xD;
      The 30% reduction used for power calculations was determined from clinical judgment, as&#xD;
      little literature exists evaluating the minimal clinically important difference of the NRS-11&#xD;
      scale for ventral hernia repair. Mean NRS-11 pain score (4.76) and standard deviation (1.975)&#xD;
      with the laparoscopic approach (control group) was determined from previously published&#xD;
      manuscripts. Assuming an alpha of 0.05, a beta of 0.20, a total sample size of 62 patients&#xD;
      (31 per arm) was calculated. Considering and a 20% drop-out rate to occur in each arm,&#xD;
      approximately 74 patients (37 patients per arm) was defined as the sample size for this&#xD;
      study. Descriptive statistics, including means, standard deviations, and/or percentages, will&#xD;
      be calculated for demographic and baseline variables. Categorical variables will be reported&#xD;
      using proportions. Continuous variables will be reported using either means and standard&#xD;
      deviations for normally distributed data or median and interquartile range for non-parametric&#xD;
      data. Pain scores will be compared between intervention arms at each time point using either&#xD;
      a Student's t-test (normal distribution) or a Kruskal-Wallis test (nonparametric&#xD;
      distribution). Differences in PROMIS scores between baseline, 30 and 365 days, respectively,&#xD;
      will be assessed via Wilcoxon signed-rank test. Recurrence rates will be compared between&#xD;
      intervention arms via Pearson's chi-square. Abdominal wall-specific quality of life scores&#xD;
      will be compared between intervention arms via Kruskal-Wallis test. Wound events will be&#xD;
      compared between intervention arms via Pearson's chi-square.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain Scores</measure>
    <time_frame>Pain scores will be assessed on postoperative day 1, day 7 and day 30</time_frame>
    <description>Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;); This will be reported using median and interquartile ranges</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Scores</measure>
    <time_frame>30 days(+-15days) postoperatively</time_frame>
    <description>Pain scores will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) 3a Pain Intensity Survey. Measured on a scale of 30.7- 71.8 with the higher numbers indicating higher pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Central Hernia Recurrence</measure>
    <time_frame>12 months +- 3 months</time_frame>
    <description>Ventral Hernia recurrence will be assessed at 1 year postoperatively, either by physical examination, imaging studies or using the validated Ventral Hernia Recurrence Inventory Survey. Rates of ventral hernia recurrence will be reported as percent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of Robotic IPOM Versus Laparoscopic IPOM</measure>
    <time_frame>Start of procedure to end of procedure which is an average of 2 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Abdominal Wall Specific Quality of Life</measure>
    <time_frame>30-days(+-15days) postoperatively</time_frame>
    <description>Abdominal Wall Specific Quality of Life will be assessed using the validated HerQLes (Hernia Related Quality of Life) survey. Scores will be reported as mean and standard deviations as appropriate on a scale from 0-100 with the larger numbers representing higher quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Surgical Site Infection</measure>
    <time_frame>30 days +- 15 days</time_frame>
    <description>Surgical site infection rates will be assessed and reported as percent</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention</measure>
    <time_frame>30 days +- 15 days</time_frame>
    <description>Surgical Site Occurrences requiring Procedural Intervention will be assessed and reported as percent</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Surgical Site Occurrences</measure>
    <time_frame>30-days +- 15 days</time_frame>
    <description>Surgical site occurrences ( defined as wound cellulitis, non-healing wound, fascial disruption, skin or soft tissue ischemia or necrosis, wound drainage, stitch abscess, seroma, hematoma, exposed, contaminated or infected mesh and enterocutaneous fistula) will be assessed and reported as percent</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>Robotic IPOM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic IPOM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic Ventral Hernia Repair with IPOM</intervention_name>
    <description>Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
    <arm_group_label>Robotic IPOM</arm_group_label>
    <other_name>da Vinci® Surgical System robotic platform</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laparoscopic Ventral Hernia Repair with IPOM</intervention_name>
    <description>Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
    <arm_group_label>Laparoscopic IPOM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;18 years old)&#xD;
&#xD;
          -  Primary or Incisional Ventral Hernia&#xD;
&#xD;
          -  Midline defect location&#xD;
&#xD;
          -  H. Width equal or less than 7 centimeters&#xD;
&#xD;
          -  Elective setting&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Able to tolerate general anesthesia&#xD;
&#xD;
          -  Considered eligible for minimally invasive ventral hernia repair&#xD;
&#xD;
          -  Willing to undergo mesh-based repair&#xD;
&#xD;
          -  Fascial closure is presumed to be achieved&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years old&#xD;
&#xD;
          -  Non-midline hernia defects&#xD;
&#xD;
          -  H. Width &gt; 7cm&#xD;
&#xD;
          -  Emergent setting ( acute incarceration or strangulation)&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Unable to tolerate general anesthesia&#xD;
&#xD;
          -  Considered not eligible for minimally invasive ventral hernia repair&#xD;
&#xD;
          -  Not willing to undergo mesh based repair&#xD;
&#xD;
          -  Fascial closure not intended or presumed not to be achieved&#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>Ajita Prabhu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Comprehensive Hernia Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Prabhu AS, Dickens EO, Copper CM, Mann JW, Yunis JP, Phillips S, Huang LC, Poulose BK, Rosen MJ. Laparoscopic vs Robotic Intraperitoneal Mesh Repair for Incisional Hernia: An Americas Hernia Society Quality Collaborative Analysis. J Am Coll Surg. 2017 Aug;225(2):285-293. doi: 10.1016/j.jamcollsurg.2017.04.011. Epub 2017 Apr 24.</citation>
    <PMID>28450062</PMID>
  </reference>
  <reference>
    <citation>Asencio F, Aguilo J, Peiro S, Carbo J, Ferri R, Caro F, Ahmad M. Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc. 2009 Jul;23(7):1441-8. doi: 10.1007/s00464-008-0230-4. Epub 2008 Dec 31.</citation>
    <PMID>19116750</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>May 11, 2022</results_first_submitted>
  <results_first_submitted_qc>June 23, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 19, 2022</results_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Ajita Prabhu, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ventral Hernia</keyword>
  <keyword>Robotic</keyword>
  <keyword>Laparoscopic</keyword>
  <keyword>Pain scores</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03283982/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03283982/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Robotic IPOM</title>
          <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
        </group>
        <group group_id="P2">
          <title>Laparoscopic IPOM</title>
          <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="36"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Robotic IPOM</title>
          <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
        </group>
        <group group_id="B2">
          <title>Laparoscopic IPOM</title>
          <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</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="39"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56" lower_limit="50" upper_limit="69.5"/>
                    <measurement group_id="B2" value="55.5" lower_limit="49" upper_limit="59.5"/>
                    <measurement group_id="B3" value="56" lower_limit="49" upper_limit="65"/>
                  </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="16"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Black/ African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain Scores</title>
        <description>Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;); This will be reported using median and interquartile ranges</description>
        <time_frame>Pain scores will be assessed on postoperative day 1, day 7 and day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Scores</title>
          <description>Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;); This will be reported using median and interquartile ranges</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Surgery Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="3" upper_limit="6"/>
                    <measurement group_id="O2" value="5" lower_limit="3" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Surgery Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Surgery Day 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain Scores</title>
        <description>Pain scores will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) 3a Pain Intensity Survey. Measured on a scale of 30.7- 71.8 with the higher numbers indicating higher pain</description>
        <time_frame>30 days(+-15days) postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Scores</title>
          <description>Pain scores will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) 3a Pain Intensity Survey. Measured on a scale of 30.7- 71.8 with the higher numbers indicating higher pain</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.9" lower_limit="40.2" upper_limit="50.1"/>
                    <measurement group_id="O2" value="46.3" lower_limit="40.2" upper_limit="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Central Hernia Recurrence</title>
        <description>Ventral Hernia recurrence will be assessed at 1 year postoperatively, either by physical examination, imaging studies or using the validated Ventral Hernia Recurrence Inventory Survey. Rates of ventral hernia recurrence will be reported as percent</description>
        <time_frame>12 months +- 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Central Hernia Recurrence</title>
          <description>Ventral Hernia recurrence will be assessed at 1 year postoperatively, either by physical examination, imaging studies or using the validated Ventral Hernia Recurrence Inventory Survey. Rates of ventral hernia recurrence will be reported as percent</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost of Robotic IPOM Versus Laparoscopic IPOM</title>
        <time_frame>Start of procedure to end of procedure which is an average of 2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Cost of Robotic IPOM Versus Laparoscopic IPOM</title>
          <units>American Dollars</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2438" lower_limit="1942" upper_limit="3245"/>
                    <measurement group_id="O2" value="2102" lower_limit="1826" upper_limit="2530"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Abdominal Wall Specific Quality of Life</title>
        <description>Abdominal Wall Specific Quality of Life will be assessed using the validated HerQLes (Hernia Related Quality of Life) survey. Scores will be reported as mean and standard deviations as appropriate on a scale from 0-100 with the larger numbers representing higher quality of life.</description>
        <time_frame>30-days(+-15days) postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Abdominal Wall Specific Quality of Life</title>
          <description>Abdominal Wall Specific Quality of Life will be assessed using the validated HerQLes (Hernia Related Quality of Life) survey. Scores will be reported as mean and standard deviations as appropriate on a scale from 0-100 with the larger numbers representing higher quality of life.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" lower_limit="46" upper_limit="80.8"/>
                    <measurement group_id="O2" value="72" lower_limit="35" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Surgical Site Infection</title>
        <description>Surgical site infection rates will be assessed and reported as percent</description>
        <time_frame>30 days +- 15 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Surgical Site Infection</title>
          <description>Surgical site infection rates will be assessed and reported as percent</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention</title>
        <description>Surgical Site Occurrences requiring Procedural Intervention will be assessed and reported as percent</description>
        <time_frame>30 days +- 15 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention</title>
          <description>Surgical Site Occurrences requiring Procedural Intervention will be assessed and reported as percent</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Surgical Site Occurrences</title>
        <description>Surgical site occurrences ( defined as wound cellulitis, non-healing wound, fascial disruption, skin or soft tissue ischemia or necrosis, wound drainage, stitch abscess, seroma, hematoma, exposed, contaminated or infected mesh and enterocutaneous fistula) will be assessed and reported as percent</description>
        <time_frame>30-days +- 15 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic IPOM</title>
            <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
          </group>
          <group group_id="O2">
            <title>Laparoscopic IPOM</title>
            <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Surgical Site Occurrences</title>
          <description>Surgical site occurrences ( defined as wound cellulitis, non-healing wound, fascial disruption, skin or soft tissue ischemia or necrosis, wound drainage, stitch abscess, seroma, hematoma, exposed, contaminated or infected mesh and enterocutaneous fistula) will be assessed and reported as percent</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year post surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Robotic IPOM</title>
          <description>Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform</description>
        </group>
        <group group_id="E2">
          <title>Laparoscopic IPOM</title>
          <description>Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.&#xD;
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bowel Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Scar Revision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Access-Related Injury</sub_title>
                <description>Injury occurring during the procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Ajita Prabhu</name_or_title>
      <organization>Cleveland Clinic Foundation</organization>
      <phone>2164444790</phone>
      <email>prabhua@ccf.org</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/NCT03283982
org study id: 17-1053
nct id: NCT03283982
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The investigators aim to conduct a registry-based, randomized controlled trial to investigate
      if the robotic platform for minimally invasive ventral hernia repair with intraperitoneal
      onlay mesh (IPOM), when compared to the laparoscopic platform, will influence on early
      postoperative pain scores, wound morbidity (surgical site infections, surgical site
      occurrences and surgical site occurrences requiring procedural intervention), ventral hernia
      recurrence rate and abdominal wall-specific quality of life.
Despite the adoption of the robotic platform for ventral hernia repair, there is still a
      paucity of literature to speak to the benefits of this approach. In a recently-published
      propensity score analysis comparing laparoscopic and robotic ventral hernia repairs with
      intraperitoneal onlay mesh (IPOM) , the authors showed a 1-day decrease in hospital length of
      stay (LOS) with the robotic versus laparoscopic platform for laparoscopic ventral hernia
      repair with IPOM. The reasons for this decrease in stay remain unknown. While multiple papers
      have described postoperative pain scores following laparoscopic ventral hernia repair, scant
      data exists evaluating postoperative pain following robotic ventral hernia repair. To help
      determine if the robotic platform has an impact on postoperative pain, wound morbidity rates,
      ventral hernia recurrence and quality of life, the investigators propose a registry-based,
      randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative
      (AHSQC). The AHSQC is a multicenter, nationwide quality improvement effort with a mission to
      improve value in hernia care. Data are collected prospectively in the routine care of hernia
      patients for quality improvement purposes. The information collected in the AHSQC offers a
      natural repository of information that can be used for research, in addition to its quality
      improvement purpose. The investigators aim to conduct a prospective, registry-based,
      single-blind, randomized controlled trial with a 1:1 allocation ratio. This will be a
      single-institutional study performed at the Cleveland Clinic Foundation in Cleveland, Ohio
      from 2017 to 2020. All enrollments and surgeries in this study will take place at the
      Cleveland Clinic Comprehensive Hernia Center. The study will consist of 2 interventions:
      laparoscopic IPOM or robotic IPOM. Participants will be randomized to laparoscopic ventral
      hernia repair with IPOM or robotic ventral hernia repair with IPOM at the moment of
      enrollment, during preoperative evaluation. Participants will be blinded to the intervention.
      Both the laparoscopic and robotic platforms represent current standards of care for ventral
      hernia repair, and both approaches are currently offered at Cleveland Clinic Comprehensive
      Hernia Center. The sample size was determined by the primary outcome of interest, the change
      in NRS-11 pain score at postoperative day 1. The investigators hypothesize that the robotic
      approach will be associated with a 30% decrease in NRS-11 pain score at postoperative day 1.
      The 30% reduction used for power calculations was determined from clinical judgment, as
      little literature exists evaluating the minimal clinically important difference of the NRS-11
      scale for ventral hernia repair. Mean NRS-11 pain score (4.76) and standard deviation (1.975)
      with the laparoscopic approach (control group) was determined from previously published
      manuscripts. Assuming an alpha of 0.05, a beta of 0.20, a total sample size of 62 patients
      (31 per arm) was calculated. Considering and a 20% drop-out rate to occur in each arm,
      approximately 74 patients (37 patients per arm) was defined as the sample size for this
      study. Descriptive statistics, including means, standard deviations, and/or percentages, will
      be calculated for demographic and baseline variables. Categorical variables will be reported
      using proportions. Continuous variables will be reported using either means and standard
      deviations for normally distributed data or median and interquartile range for non-parametric
      data. Pain scores will be compared between intervention arms at each time point using either
      a Student's t-test (normal distribution) or a Kruskal-Wallis test (nonparametric
      distribution). Differences in PROMIS scores between baseline, 30 and 365 days, respectively,
      will be assessed via Wilcoxon signed-rank test. Recurrence rates will be compared between
      intervention arms via Pearson's chi-square. Abdominal wall-specific quality of life scores
      will be compared between intervention arms via Kruskal-Wallis test. Wound events will be
      compared between intervention arms via Pearson's chi-square.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Postoperative Pain Scores
time frame: Pain scores will be assessed on postoperative day 1, day 7 and day 30
description: Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"); This will be reported using median and interquartile ranges
measure: Postoperative Pain Scores
time frame: 30 days(+-15days) postoperatively
description: Pain scores will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) 3a Pain Intensity Survey. Measured on a scale of 30.7- 71.8 with the higher numbers indicating higher pain
measure: Number of Participants With Central Hernia Recurrence
time frame: 12 months +- 3 months
description: Ventral Hernia recurrence will be assessed at 1 year postoperatively, either by physical examination, imaging studies or using the validated Ventral Hernia Recurrence Inventory Survey. Rates of ventral hernia recurrence will be reported as percent
measure: Cost of Robotic IPOM Versus Laparoscopic IPOM
time frame: Start of procedure to end of procedure which is an average of 2 hours
measure: Abdominal Wall Specific Quality of Life
time frame: 30-days(+-15days) postoperatively
description: Abdominal Wall Specific Quality of Life will be assessed using the validated HerQLes (Hernia Related Quality of Life) survey. Scores will be reported as mean and standard deviations as appropriate on a scale from 0-100 with the larger numbers representing higher quality of life.
measure: Number of Participants With Surgical Site Infection
time frame: 30 days +- 15 days
description: Surgical site infection rates will be assessed and reported as percent
measure: Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention
time frame: 30 days +- 15 days
description: Surgical Site Occurrences requiring Procedural Intervention will be assessed and reported as percent
measure: Number of Participants With Surgical Site Occurrences
time frame: 30-days +- 15 days
description: Surgical site occurrences ( defined as wound cellulitis, non-healing wound, fascial disruption, skin or soft tissue ischemia or necrosis, wound drainage, stitch abscess, seroma, hematoma, exposed, contaminated or infected mesh and enterocutaneous fistula) will be assessed and reported as percent
arm group label: Robotic IPOM
arm group type: Active Comparator
description: Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
arm group label: Laparoscopic IPOM
arm group type: Active Comparator
description: Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
intervention type: Device
intervention name: Robotic Ventral Hernia Repair with IPOM
description: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
arm group label: Robotic IPOM
other name: da Vinci® Surgical System robotic platform
intervention type: Device
intervention name: Laparoscopic Ventral Hernia Repair with IPOM
description: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
arm group label: Laparoscopic IPOM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ajita Prabhu, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Prabhu AS, Dickens EO, Copper CM, Mann JW, Yunis JP, Phillips S, Huang LC, Poulose BK, Rosen MJ. Laparoscopic vs Robotic Intraperitoneal Mesh Repair for Incisional Hernia: An Americas Hernia Society Quality Collaborative Analysis. J Am Coll Surg. 2017 Aug;225(2):285-293. doi: 10.1016/j.jamcollsurg.2017.04.011. Epub 2017 Apr 24.
PMID: 28450062
citation: Asencio F, Aguilo J, Peiro S, Carbo J, Ferri R, Caro F, Ahmad M. Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc. 2009 Jul;23(7):1441-8. doi: 10.1007/s00464-008-0230-4. Epub 2008 Dec 31.
PMID: 19116750
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Ajita Prabhu, MD
investigator title: Principal Investigator
mesh term: Hernia
mesh term: Hernia, Ventral
sharing ipd: No
ipd description: No IPD will be shared.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 