<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/NCT03276871</url>
  </required_header>
  <id_info>
    <org_study_id>17-1045</org_study_id>
    <nct_id>NCT03276871</nct_id>
  </id_info>
  <brief_title>Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair</brief_title>
  <official_title>Randomized Controlled Trial Comparing Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the surgical technique for creation of&#xD;
      extraperitoneal space during laparoscopic TEP inguinal hernia repair (telescopic dissection&#xD;
      or balloon dissection) has an impact on operative times, early postoperative pain scores,&#xD;
      surgical complications and rate of hernia recurrence following laparoscopic TEP inguinal&#xD;
      hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Minimally invasive approaches have been successfully incorporated into the surgical&#xD;
      armamentarium of inguinal hernia repair, with proven benefits for decreased postoperative&#xD;
      pain and earlier return to work. Laparoscopic inguinal hernia repair is more commonly&#xD;
      performed through the transabdominal preperitoneal (TAPP) approach or the totally&#xD;
      extraperitoneal (TEP) approach. The TEP approach has been proven to have equivalent&#xD;
      recurrence rates, decreased postoperative pain, earlier ambulation and return to work when&#xD;
      compared to the open, tension-free repairs. Additionally, when compared to TAPP, the TEP&#xD;
      approach has also been associated with decreased postoperative pain, shorter operative times&#xD;
      and equivalent rates of postoperative complications and hernia recurrence.&#xD;
&#xD;
      A key step in the TEP procedure is the creation of the extraperitoneal space, which can be&#xD;
      performed by two different techniques: telescopic dissection or balloon dissection.Telescopic&#xD;
      dissection is the creation of the extraperitoneal space with blunt dissection performed with&#xD;
      the laparoscopic probe. Telescopic dissection was initially described in the original paper&#xD;
      describing the TEP procedure, in 1992 by Ferzli et al. To date, telescopic dissection is&#xD;
      still used in many centers around the globe. In order to facilitate the creation of the&#xD;
      initial working space, disposable dissection balloons have been developed and are&#xD;
      commercially available. Balloon dissection is now the most commonly used method for creation&#xD;
      of the extraperitoneal space for TEP procedure in the United States. A randomized,&#xD;
      prospective multicenter study conducted between 1994 and 1997 and published in 2001 by&#xD;
      Bringmam and colleagues has compared operative times, conversion rates, postoperative&#xD;
      morbidity and time to return to work between patients in which the TEP procedure was&#xD;
      performed with or without the balloon dissector. In this study, the use of the balloon was&#xD;
      associated with lower conversion rates and statistically, but perhaps not clinically,&#xD;
      significantly shorter operative times (9 minutes difference). No difference was seen in&#xD;
      postoperative morbidity, recurrence rates or time to return to work between the groups. Of&#xD;
      note, the surgeons performing these procedures were still at an early point of their learning&#xD;
      curve for the TEP procedure, which might have influenced the results, especially for the&#xD;
      group without the balloon.&#xD;
&#xD;
      Low-cost alternatives have been proposed to substitute the commercially available balloon&#xD;
      dissector, especially in developing countries where the access to the balloon dissector is&#xD;
      restricted. Despite the fact that the TEP procedure has become more popular in the last 15&#xD;
      years, with surgeons being each time more proficient in this operation, there is a paucity of&#xD;
      data comparing cost and surgical outcomes among telescopic and balloon dissection.&#xD;
&#xD;
      Furthermore, according to current consensus, the use of a balloon dissector is especially&#xD;
      recommended during the learning period when surgeons are still unfamiliar with the&#xD;
      preperitoneal anatomy. Especially for expert surgeons, delineation of the inguinal area and&#xD;
      dissection in the creation of extraperitoneal space can be performed as safe and efficient&#xD;
      with telescopic dissection.&#xD;
&#xD;
      The investigator's institution has in its staff, three expert surgeons, with a robust&#xD;
      experience in the TEP procedure, performed either telescopic or balloon dissection. To help&#xD;
      determine if the use of the balloon dissector is associated with a significant decrease in&#xD;
      operative times when compared to telescopic dissection, the investigators aim to conduct a&#xD;
      randomized controlled trial using the Americas Hernia Society Quality Collaborative (AHSQC)&#xD;
      registry. The AHSQC is a nationwide registry designed to improve the value of hernia care&#xD;
      using real-time continuous quality improvement principles. Data pertaining to baseline and&#xD;
      intraoperative variables, short and long term outcomes are collected prospectively for&#xD;
      quality improvement purposes. The information collected in the AHSQC offers a natural&#xD;
      repository of information that can be used for research, in addition to its quality&#xD;
      improvement purpose.&#xD;
&#xD;
      The investigators hypothesize that at their institution, during TEP repairs, telescopic&#xD;
      dissection will be associated with a 15-minute increase in total operative times for a&#xD;
      unilateral inguinal hernia, when compared to the balloon dissection.&#xD;
&#xD;
      Specific Aim #1: To determine if the use of a balloon dissector by an experienced surgeon is&#xD;
      associated with a significant decrease in total operative time compared to telescopic&#xD;
      dissection for the creation of the extraperitoneal space during laparoscopic TEP inguinal&#xD;
      hernia repair Specific Aim #2: To determine if there is a difference in postoperative pain&#xD;
      scores at 1 day, 7 days and 30 days postoperatively between patients who have undergone&#xD;
      laparoscopic TEP inguinal hernia repair performed either with telescopic dissection or&#xD;
      balloon dissection.&#xD;
&#xD;
      Specific Aim #3: To determine if there is a difference in the rate of intraoperative&#xD;
      complications and 30-day wound events between patients who have undergone laparoscopic TEP&#xD;
      inguinal hernia repair performed either with telescopic dissection or balloon dissection.&#xD;
&#xD;
      Specific Aim #4: To determine if 1-year hernia recurrence rates differ between patients who&#xD;
      have undergone laparoscopic TEP inguinal hernia repair performed either with telescopic&#xD;
      dissection or balloon dissection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">July 6, 2019</completion_date>
  <primary_completion_date type="Actual">July 6, 2019</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>Operative Time</measure>
    <time_frame>Measured from start to end of procedure</time_frame>
    <description>Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NRS-11 Pain Scores</measure>
    <time_frame>Postoperative day 1, Postoperative day 7 and Postoperative day 30</time_frame>
    <description>Early postoperative pain scores; Pain scores measured with the Numeric Pain Rating Scale (NRS-11) pain score at postoperative days 1, 7 and 30. Pain ratings will be reported as median and inter-quartile range. Scores can range from 0 to 10, higher numbers represent more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Intra-operative Complications</measure>
    <time_frame>Intraoperative complications recorded during the procedure, up to closure of the incisions</time_frame>
    <description>Rate of any Intra-operative complications; rate will be reported in number and percent as appropriate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day SSO (Surgical Site Occurrences) Rate</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>30-day rate of Surgical Site Occurrences which includes any surgical site infection as well as wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous drainage, seroma, hematoma, or development of an enterocutaneous fistula. The rate will be reported in number and percent as appropriate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Balloon Dissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telescopic Dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Telescopic Dissection</intervention_name>
    <description>Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</description>
    <arm_group_label>Telescopic Dissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Balloon Dissection</intervention_name>
    <description>Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
    <arm_group_label>Balloon Dissection</arm_group_label>
    <other_name>SpaceMaker Balloon Dissector</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Unilateral inguinal hernia&#xD;
&#xD;
          -  Scheduled for elective inguinal hernia repair&#xD;
&#xD;
          -  Eligible to tolerate general anesthesia&#xD;
&#xD;
          -  Eligible to undergo minimally invasive inguinal hernia repair&#xD;
&#xD;
          -  Willing to undergo mesh-based repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years old&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Bilateral Inguinal hernias&#xD;
&#xD;
          -  Emergent inguinal hernia repairs ( acute incarceration or strangulation)&#xD;
&#xD;
          -  Recurrent inguinal hernia with prior preperitoneal mesh&#xD;
&#xD;
          -  Unable to tolerate general anesthesia&#xD;
&#xD;
          -  Not eligible for minimally invasive inguinal hernia repair&#xD;
&#xD;
          -  Not willing to undergo mesh-based repair&#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>Michael J Rosen, 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>Berney CR. Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia. Surg Endosc. 2012 Nov;26(11):3350-1. doi: 10.1007/s00464-012-2293-5. Epub 2012 Apr 27. No abstract available.</citation>
    <PMID>22538696</PMID>
  </reference>
  <reference>
    <citation>Ferzli GS, Massad A, Albert P. Extraperitoneal endoscopic inguinal hernia repair. J Laparoendosc Surg. 1992 Dec;2(6):281-6. doi: 10.1089/lps.1992.2.281.</citation>
    <PMID>1489992</PMID>
  </reference>
  <reference>
    <citation>Bringman S, Ek A, Haglind E, Heikkinen T, Kald A, Kylberg F, Ramel S, Wallon C, Anderberg B. Is a dissection balloon beneficial in totally extraperitoneal endoscopic hernioplasty (TEP)? A randomized prospective multicenter study. Surg Endosc. 2001 Mar;15(3):266-70. doi: 10.1007/s004640000367. Epub 2001 Feb 27.</citation>
    <PMID>11344426</PMID>
  </reference>
  <reference>
    <citation>Poulose BK, Roll S, Murphy JW, Matthews BD, Todd Heniford B, Voeller G, Hope WW, Goldblatt MI, Adrales GL, Rosen MJ. Design and implementation of the Americas Hernia Society Quality Collaborative (AHSQC): improving value in hernia care. Hernia. 2016 Apr;20(2):177-89. doi: 10.1007/s10029-016-1477-7. Epub 2016 Mar 2.</citation>
    <PMID>26936373</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <results_first_submitted>June 23, 2020</results_first_submitted>
  <results_first_submitted_qc>July 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 22, 2020</results_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Michael Rosen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Balloon dissection</keyword>
  <keyword>Telescopic dissection</keyword>
  <keyword>Inguinal hernia</keyword>
  <keyword>TEP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared, rather the results of the aggregate groups of patients 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>August 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03276871/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Balloon Dissection</title>
          <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.&#xD;
Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
        </group>
        <group group_id="P2">
          <title>Telescopic Dissection</title>
          <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.&#xD;
Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </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>Balloon Dissection</title>
          <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.&#xD;
Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
        </group>
        <group group_id="B2">
          <title>Telescopic Dissection</title>
          <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.&#xD;
Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</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="21"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </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="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index</description>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" lower_limit="24.3" upper_limit="27.5"/>
                    <measurement group_id="B2" value="25.7" lower_limit="24.4" upper_limit="28.9"/>
                    <measurement group_id="B3" value="25.9" lower_limit="24.2" upper_limit="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>COPD</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Operative Time</title>
        <description>Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.</description>
        <time_frame>Measured from start to end of procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.&#xD;
Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
          </group>
          <group group_id="O2">
            <title>Telescopic Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.&#xD;
Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Time</title>
          <description>Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.</description>
          <units>minutes</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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" lower_limit="33" upper_limit="63"/>
                    <measurement group_id="O2" value="43" lower_limit="35" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NRS-11 Pain Scores</title>
        <description>Early postoperative pain scores; Pain scores measured with the Numeric Pain Rating Scale (NRS-11) pain score at postoperative days 1, 7 and 30. Pain ratings will be reported as median and inter-quartile range. Scores can range from 0 to 10, higher numbers represent more pain.</description>
        <time_frame>Postoperative day 1, Postoperative day 7 and Postoperative day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.&#xD;
Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
          </group>
          <group group_id="O2">
            <title>Telescopic Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.&#xD;
Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</description>
          </group>
        </group_list>
        <measure>
          <title>NRS-11 Pain Scores</title>
          <description>Early postoperative pain scores; Pain scores measured with the Numeric Pain Rating Scale (NRS-11) pain score at postoperative days 1, 7 and 30. Pain ratings will be reported as median and inter-quartile range. Scores can range from 0 to 10, higher numbers represent more pain.</description>
          <units>units 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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NRS-11, Postop day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRS-11, Postop day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0.75" upper_limit="3.25"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.25" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRS-11, 30-day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Intra-operative Complications</title>
        <description>Rate of any Intra-operative complications; rate will be reported in number and percent as appropriate</description>
        <time_frame>Intraoperative complications recorded during the procedure, up to closure of the incisions</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.&#xD;
Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
          </group>
          <group group_id="O2">
            <title>Telescopic Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.&#xD;
Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Intra-operative Complications</title>
          <description>Rate of any Intra-operative complications; rate will be reported in number and percent as appropriate</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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <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>
        <type>Secondary</type>
        <title>30-day SSO (Surgical Site Occurrences) Rate</title>
        <description>30-day rate of Surgical Site Occurrences which includes any surgical site infection as well as wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous drainage, seroma, hematoma, or development of an enterocutaneous fistula. The rate will be reported in number and percent as appropriate</description>
        <time_frame>30 days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Balloon Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.&#xD;
Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
          </group>
          <group group_id="O2">
            <title>Telescopic Dissection</title>
            <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.&#xD;
Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</description>
          </group>
        </group_list>
        <measure>
          <title>30-day SSO (Surgical Site Occurrences) Rate</title>
          <description>30-day rate of Surgical Site Occurrences which includes any surgical site infection as well as wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous drainage, seroma, hematoma, or development of an enterocutaneous fistula. The rate will be reported in number and percent as appropriate</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="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse event data were collected up to 30 days following surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Balloon Dissection</title>
          <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.&#xD;
Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector</description>
        </group>
        <group group_id="E2">
          <title>Telescopic Dissection</title>
          <description>Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.&#xD;
Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe</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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Port site hernia requiring reoperation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </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="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="19"/>
              </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="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </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>Aldo Fafaj</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>2162195943</phone>
      <email>fafaja@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/NCT03276871
org study id: 17-1045
nct id: NCT03276871
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine if the surgical technique for creation of
      extraperitoneal space during laparoscopic TEP inguinal hernia repair (telescopic dissection
      or balloon dissection) has an impact on operative times, early postoperative pain scores,
      surgical complications and rate of hernia recurrence following laparoscopic TEP inguinal
      hernia repair.
Minimally invasive approaches have been successfully incorporated into the surgical
      armamentarium of inguinal hernia repair, with proven benefits for decreased postoperative
      pain and earlier return to work. Laparoscopic inguinal hernia repair is more commonly
      performed through the transabdominal preperitoneal (TAPP) approach or the totally
      extraperitoneal (TEP) approach. The TEP approach has been proven to have equivalent
      recurrence rates, decreased postoperative pain, earlier ambulation and return to work when
      compared to the open, tension-free repairs. Additionally, when compared to TAPP, the TEP
      approach has also been associated with decreased postoperative pain, shorter operative times
      and equivalent rates of postoperative complications and hernia recurrence.

      A key step in the TEP procedure is the creation of the extraperitoneal space, which can be
      performed by two different techniques: telescopic dissection or balloon dissection.Telescopic
      dissection is the creation of the extraperitoneal space with blunt dissection performed with
      the laparoscopic probe. Telescopic dissection was initially described in the original paper
      describing the TEP procedure, in 1992 by Ferzli et al. To date, telescopic dissection is
      still used in many centers around the globe. In order to facilitate the creation of the
      initial working space, disposable dissection balloons have been developed and are
      commercially available. Balloon dissection is now the most commonly used method for creation
      of the extraperitoneal space for TEP procedure in the United States. A randomized,
      prospective multicenter study conducted between 1994 and 1997 and published in 2001 by
      Bringmam and colleagues has compared operative times, conversion rates, postoperative
      morbidity and time to return to work between patients in which the TEP procedure was
      performed with or without the balloon dissector. In this study, the use of the balloon was
      associated with lower conversion rates and statistically, but perhaps not clinically,
      significantly shorter operative times (9 minutes difference). No difference was seen in
      postoperative morbidity, recurrence rates or time to return to work between the groups. Of
      note, the surgeons performing these procedures were still at an early point of their learning
      curve for the TEP procedure, which might have influenced the results, especially for the
      group without the balloon.

      Low-cost alternatives have been proposed to substitute the commercially available balloon
      dissector, especially in developing countries where the access to the balloon dissector is
      restricted. Despite the fact that the TEP procedure has become more popular in the last 15
      years, with surgeons being each time more proficient in this operation, there is a paucity of
      data comparing cost and surgical outcomes among telescopic and balloon dissection.

      Furthermore, according to current consensus, the use of a balloon dissector is especially
      recommended during the learning period when surgeons are still unfamiliar with the
      preperitoneal anatomy. Especially for expert surgeons, delineation of the inguinal area and
      dissection in the creation of extraperitoneal space can be performed as safe and efficient
      with telescopic dissection.

      The investigator's institution has in its staff, three expert surgeons, with a robust
      experience in the TEP procedure, performed either telescopic or balloon dissection. To help
      determine if the use of the balloon dissector is associated with a significant decrease in
      operative times when compared to telescopic dissection, the investigators aim to conduct a
      randomized controlled trial using the Americas Hernia Society Quality Collaborative (AHSQC)
      registry. The AHSQC is a nationwide registry designed to improve the value of hernia care
      using real-time continuous quality improvement principles. Data pertaining to baseline and
      intraoperative variables, short and long term outcomes are collected prospectively 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 hypothesize that at their institution, during TEP repairs, telescopic
      dissection will be associated with a 15-minute increase in total operative times for a
      unilateral inguinal hernia, when compared to the balloon dissection.

      Specific Aim #1: To determine if the use of a balloon dissector by an experienced surgeon is
      associated with a significant decrease in total operative time compared to telescopic
      dissection for the creation of the extraperitoneal space during laparoscopic TEP inguinal
      hernia repair Specific Aim #2: To determine if there is a difference in postoperative pain
      scores at 1 day, 7 days and 30 days postoperatively between patients who have undergone
      laparoscopic TEP inguinal hernia repair performed either with telescopic dissection or
      balloon dissection.

      Specific Aim #3: To determine if there is a difference in the rate of intraoperative
      complications and 30-day wound events between patients who have undergone laparoscopic TEP
      inguinal hernia repair performed either with telescopic dissection or balloon dissection.

      Specific Aim #4: To determine if 1-year hernia recurrence rates differ between patients who
      have undergone laparoscopic TEP inguinal hernia repair performed either with telescopic
      dissection or balloon dissection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Operative Time
time frame: Measured from start to end of procedure
description: Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.
measure: NRS-11 Pain Scores
time frame: Postoperative day 1, Postoperative day 7 and Postoperative day 30
description: Early postoperative pain scores; Pain scores measured with the Numeric Pain Rating Scale (NRS-11) pain score at postoperative days 1, 7 and 30. Pain ratings will be reported as median and inter-quartile range. Scores can range from 0 to 10, higher numbers represent more pain.
measure: Number of Participants With Intra-operative Complications
time frame: Intraoperative complications recorded during the procedure, up to closure of the incisions
description: Rate of any Intra-operative complications; rate will be reported in number and percent as appropriate
measure: 30-day SSO (Surgical Site Occurrences) Rate
time frame: 30 days after surgery
description: 30-day rate of Surgical Site Occurrences which includes any surgical site infection as well as wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous drainage, seroma, hematoma, or development of an enterocutaneous fistula. The rate will be reported in number and percent as appropriate
arm group label: Balloon Dissection
arm group type: Active Comparator
description: Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector.
arm group label: Telescopic Dissection
arm group type: Experimental
description: Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique.
intervention type: Procedure
intervention name: Telescopic Dissection
description: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
arm group label: Telescopic Dissection
intervention type: Device
intervention name: Balloon Dissection
description: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector
arm group label: Balloon Dissection
other name: SpaceMaker Balloon Dissector
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael J Rosen, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Berney CR. Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia. Surg Endosc. 2012 Nov;26(11):3350-1. doi: 10.1007/s00464-012-2293-5. Epub 2012 Apr 27. No abstract available.
PMID: 22538696
citation: Ferzli GS, Massad A, Albert P. Extraperitoneal endoscopic inguinal hernia repair. J Laparoendosc Surg. 1992 Dec;2(6):281-6. doi: 10.1089/lps.1992.2.281.
PMID: 1489992
citation: Bringman S, Ek A, Haglind E, Heikkinen T, Kald A, Kylberg F, Ramel S, Wallon C, Anderberg B. Is a dissection balloon beneficial in totally extraperitoneal endoscopic hernioplasty (TEP)? A randomized prospective multicenter study. Surg Endosc. 2001 Mar;15(3):266-70. doi: 10.1007/s004640000367. Epub 2001 Feb 27.
PMID: 11344426
citation: Poulose BK, Roll S, Murphy JW, Matthews BD, Todd Heniford B, Voeller G, Hope WW, Goldblatt MI, Adrales GL, Rosen MJ. Design and implementation of the Americas Hernia Society Quality Collaborative (AHSQC): improving value in hernia care. Hernia. 2016 Apr;20(2):177-89. doi: 10.1007/s10029-016-1477-7. Epub 2016 Mar 2.
PMID: 26936373
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Michael Rosen
investigator title: MD
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No
ipd description: Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 