<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/NCT01707095</url>
  </required_header>
  <id_info>
    <org_study_id>12-0906</org_study_id>
    <nct_id>NCT01707095</nct_id>
  </id_info>
  <brief_title>Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord</brief_title>
  <official_title>Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive&#xD;
      coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent&#xD;
      to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to&#xD;
      the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653]&#xD;
      In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar&#xD;
      site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic&#xD;
      cholecystectomy. Our benchtop research compared bundling of the camera cord with the active&#xD;
      electrode cord versus unbundling of the camera cord with the active electrode cord and found&#xD;
      a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL, Robinson,&#xD;
      TN, et al. Surg Endosc (2012) Epub.]&#xD;
&#xD;
      This study plans to compare thermal injury which occurs during two commonly used operating&#xD;
      room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords.&#xD;
      And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The&#xD;
      primary outcome is the incidence of thermal injury at the skin adjacent to the camera port&#xD;
      site (the umbilical port) that will be diagnosed by histology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We hypothesize that the unbundling of camera and active electrode cords will reduce the&#xD;
      incidence of capacitive coupling thermal injuries to the skin adjacent to the camera port&#xD;
      site in comparison to bundled active electrodes/camera cords during laparoscopic&#xD;
      cholecystectomy operations.&#xD;
&#xD;
      SPECIFIC AIMS:&#xD;
&#xD;
        1. Compare incidence of skin burns by histology at the camera port site (umbilical port&#xD;
           site) with bundled active electrode/camera cords to unbundled active electrode/camera&#xD;
           cords.&#xD;
&#xD;
        2. Compare incidence of skin burns by histology at the active electrode port site&#xD;
           (epigastric port site) with bundled active electrode/camera cords to unbundled active&#xD;
           electrode/camera cords.&#xD;
&#xD;
        3. Compare incidence of skin burns by histology at the assistant port site with bundled&#xD;
           active electrode/camera cords to unbundled active electrode/camera cords.&#xD;
&#xD;
      OUTCOME MEASURE:&#xD;
&#xD;
      Histologic evidence of thermal injury at the skin biopsy sites of the active electrode port,&#xD;
      the camera port and the medial assistant port.&#xD;
&#xD;
      POPULATION TO BE ENROLLED:&#xD;
&#xD;
      Subjects undergoing elective cholecystectomy will be recruited in pre-operative clinic. All&#xD;
      subjects will be 18 years and older.&#xD;
&#xD;
      STUDY DESIGN AND METHODS:&#xD;
&#xD;
      Written informed consent will be obtained in all subjects prior to enrollment. Subjects will&#xD;
      be randomized on the day of surgery to undergo the laparoscopic cholecystectomy operation&#xD;
      with either the bundled or unbundled camera and active electrode cords. The randomization&#xD;
      process will occur by a random number generator. A total of 84 subjects will be recruited; 42&#xD;
      subjects per group. Shave skin biopsies will be performed at the lower edge of the incisions&#xD;
      of the active electrode port, the camera port and the medial assistant port. The incisions&#xD;
      and skin will be otherwise opened and closed in the routine clinical manner. The biopsy&#xD;
      specimens will be analyzed for thermal injury by a blinded pathologist.&#xD;
&#xD;
      The incidence of skin burns created bundled or unbundled camera and active electrode cords&#xD;
      will be compared individually at all three port sites by a blinded pathologist for histologic&#xD;
      evidence of thermal injury.&#xD;
&#xD;
      Statistical analysis using a chi-squared test will be comparing the incidence of thermal&#xD;
      injury at the each biopsy site for subjects with and without bundled cords. The primary&#xD;
      outcome variable is thermal injury of skin at the umbilical trocar site, which is the camera&#xD;
      trocar.&#xD;
&#xD;
      Baseline demographic information will be recorded on all patients: age, gender, BMI,&#xD;
      operating room time, pre-op diagnosis, gallbladder histology, blood loss, and need to convert&#xD;
      to open surgery.&#xD;
&#xD;
      SAMPLE SIZE CALCULATION:&#xD;
&#xD;
      The incidence of skin burns at the umbilical trocar site with bundled cords was 55% (11/20)&#xD;
      in our previous study. Our prior benchtop research found that bundled cords resulted in an&#xD;
      increase of temperature of 38.2°C at the tip of the telescope in comparison to a 15.7°C&#xD;
      increase in temperature with separated cords. This finding suggests that 41% (15.7/38.2) of&#xD;
      the heat is produced when the camera cord is unbundled from the active electrode cord in&#xD;
      comparison to when the cords are bundled. This data is used to estimate that the unbundled&#xD;
      cord group will have an incidence of thermal injury of 23% (0.41 x 55%).&#xD;
&#xD;
      Power 80% A sample size calculation comparing proportions was performed which compared 0.55&#xD;
      (bundled cords) incidence of thermal injury versus 0.23 (unbundled cords) incidence of&#xD;
      thermal injury. A sample size of 36 per group has the power (1-β) 0.80 to detect a difference&#xD;
      assuming α=0.05. We estimate a 15% dropout rate (this would be individuals who between their&#xD;
      consent in pre-operative clinic and their operation decide to withdraw from the study). A 15%&#xD;
      dropout rate is conservative in light of our prior experience recruiting similar patients&#xD;
      when 0% (0/40) of individuals dropped out. Total sample size is estimated to be 72 (36 for&#xD;
      each of two groups) plus 11 (15% dropout) for a total of 84 subjects.&#xD;
&#xD;
      STATISTICAL ANALYSIS:&#xD;
&#xD;
      The incidence of thermal injury to the skin (dichotomous variable) in the groups that had&#xD;
      unbundled or bundled camera/active electrode cords will be compared using the Fischer's exact&#xD;
      chi squared test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Histologic Thermal Injury to Umbilical Port Site Skin</measure>
    <time_frame>1 day</time_frame>
    <description>Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histologic Evidence of Burn at the Epigastric Port Site Skin.</measure>
    <time_frame>1 day</time_frame>
    <description>Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Bundling of cords</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unbundling of cords</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unbundling of cords</intervention_name>
    <description>The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another</description>
    <arm_group_label>Unbundling of cords</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bundling of cords</intervention_name>
    <description>The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.</description>
    <arm_group_label>Bundling of cords</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older planned to undergo an elective laparoscopic cholecystectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing urgent or emergent laparoscopic cholecystectomy operations&#xD;
&#xD;
          -  Patients younger than 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas N Robinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Willson PD, van der Walt JD, Moxon D, Rogers J. Port site electrosurgical (diathermy) burns during surgical laparoscopy. Surg Endosc. 1997 Jun;11(6):653-4. doi: 10.1007/s004649900414.</citation>
    <PMID>9171127</PMID>
  </reference>
  <reference>
    <citation>Wu MP, Ou CS, Chen SL, Yen EY, Rowbotham R. Complications and recommended practices for electrosurgery in laparoscopy. Am J Surg. 2000 Jan;179(1):67-73. doi: 10.1016/s0002-9610(99)00267-6.</citation>
    <PMID>10737583</PMID>
  </reference>
  <reference>
    <citation>Jones EL, Robinson TN, McHenry JR, Dunn CL, Montero PN, Govekar HR, Stiegmann GV. Radiofrequency energy antenna coupling to common laparoscopic instruments: practical implications. Surg Endosc. 2012 Nov;26(11):3053-7. doi: 10.1007/s00464-012-2312-6. Epub 2012 May 12.</citation>
    <PMID>22580879</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>May 27, 2014</results_first_submitted>
  <results_first_submitted_qc>May 27, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 27, 2014</results_first_posted>
  <last_update_submitted>July 3, 2014</last_update_submitted>
  <last_update_submitted_qc>July 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electrosurgery</keyword>
  <keyword>Radiofrequency energy</keyword>
  <keyword>Monopolar instruments</keyword>
  <keyword>Capacitive coupling</keyword>
  <keyword>Thermal injury</keyword>
  <keyword>Surgical complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bundled</title>
          <description>Active electrode cord and camera cord parallel</description>
        </group>
        <group group_id="P2">
          <title>Unbundled / Separated</title>
          <description>Active electrode cord and camera cord separated</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="42"/>
              </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>Bundling of Cords</title>
          <description>The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.&#xD;
Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.</description>
        </group>
        <group group_id="B2">
          <title>Unbundling of Cords</title>
          <description>The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another&#xD;
Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another</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="42"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="84"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44" spread="15"/>
                    <measurement group_id="B2" value="44" spread="18"/>
                    <measurement group_id="B3" value="44" spread="17"/>
                  </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="37"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Histologic Thermal Injury to Umbilical Port Site Skin</title>
        <description>Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bundled</title>
            <description>Active electrode cord and camera cord parallel</description>
          </group>
          <group group_id="O2">
            <title>Unbundled / Separated</title>
            <description>Active electrode cord and camera cord separated</description>
          </group>
        </group_list>
        <measure>
          <title>Histologic Thermal Injury to Umbilical Port Site Skin</title>
          <description>Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Histologic Evidence of Burn at the Epigastric Port Site Skin.</title>
        <description>Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bundled</title>
            <description>Active electrode cord and camera cord parallel</description>
          </group>
          <group group_id="O2">
            <title>Unbundled / Separated</title>
            <description>Active electrode cord and camera cord separated</description>
          </group>
        </group_list>
        <measure>
          <title>Histologic Evidence of Burn at the Epigastric Port Site Skin.</title>
          <description>Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bundled</title>
          <description>Active electrode cord and camera cord parallel</description>
        </group>
        <group group_id="E2">
          <title>Unbundled / Separated</title>
          <description>Active electrode cord and camera cord separated</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Thomas Robinson</name_or_title>
      <organization>University of Colorado</organization>
      <phone>303-724-2728</phone>
      <email>thomas.robinson@ucdenver.edu</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/NCT01707095
org study id: 12-0906
nct id: NCT01707095
lead sponsor: 
has dmc: No
Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive
      coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent
      to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to
      the skin occurs during a laparoscopic operation. [Willson et al. Surg Endosc (1997) 11:653]
      In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar
      site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic
      cholecystectomy. Our benchtop research compared bundling of the camera cord with the active
      electrode cord versus unbundling of the camera cord with the active electrode cord and found
      a 59% decrease in heat generated in the unbundling experimental set-up. [Jones, EL, Robinson,
      TN, et al. Surg Endosc (2012) Epub.]

      This study plans to compare thermal injury which occurs during two commonly used operating
      room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords.
      And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The
      primary outcome is the incidence of thermal injury at the skin adjacent to the camera port
      site (the umbilical port) that will be diagnosed by histology.
We hypothesize that the unbundling of camera and active electrode cords will reduce the
      incidence of capacitive coupling thermal injuries to the skin adjacent to the camera port
      site in comparison to bundled active electrodes/camera cords during laparoscopic
      cholecystectomy operations.

      SPECIFIC AIMS:

        1. Compare incidence of skin burns by histology at the camera port site (umbilical port
           site) with bundled active electrode/camera cords to unbundled active electrode/camera
           cords.

        2. Compare incidence of skin burns by histology at the active electrode port site
           (epigastric port site) with bundled active electrode/camera cords to unbundled active
           electrode/camera cords.

        3. Compare incidence of skin burns by histology at the assistant port site with bundled
           active electrode/camera cords to unbundled active electrode/camera cords.

      OUTCOME MEASURE:

      Histologic evidence of thermal injury at the skin biopsy sites of the active electrode port,
      the camera port and the medial assistant port.

      POPULATION TO BE ENROLLED:

      Subjects undergoing elective cholecystectomy will be recruited in pre-operative clinic. All
      subjects will be 18 years and older.

      STUDY DESIGN AND METHODS:

      Written informed consent will be obtained in all subjects prior to enrollment. Subjects will
      be randomized on the day of surgery to undergo the laparoscopic cholecystectomy operation
      with either the bundled or unbundled camera and active electrode cords. The randomization
      process will occur by a random number generator. A total of 84 subjects will be recruited; 42
      subjects per group. Shave skin biopsies will be performed at the lower edge of the incisions
      of the active electrode port, the camera port and the medial assistant port. The incisions
      and skin will be otherwise opened and closed in the routine clinical manner. The biopsy
      specimens will be analyzed for thermal injury by a blinded pathologist.

      The incidence of skin burns created bundled or unbundled camera and active electrode cords
      will be compared individually at all three port sites by a blinded pathologist for histologic
      evidence of thermal injury.

      Statistical analysis using a chi-squared test will be comparing the incidence of thermal
      injury at the each biopsy site for subjects with and without bundled cords. The primary
      outcome variable is thermal injury of skin at the umbilical trocar site, which is the camera
      trocar.

      Baseline demographic information will be recorded on all patients: age, gender, BMI,
      operating room time, pre-op diagnosis, gallbladder histology, blood loss, and need to convert
      to open surgery.

      SAMPLE SIZE CALCULATION:

      The incidence of skin burns at the umbilical trocar site with bundled cords was 55% (11/20)
      in our previous study. Our prior benchtop research found that bundled cords resulted in an
      increase of temperature of 38.2°C at the tip of the telescope in comparison to a 15.7°C
      increase in temperature with separated cords. This finding suggests that 41% (15.7/38.2) of
      the heat is produced when the camera cord is unbundled from the active electrode cord in
      comparison to when the cords are bundled. This data is used to estimate that the unbundled
      cord group will have an incidence of thermal injury of 23% (0.41 x 55%).

      Power 80% A sample size calculation comparing proportions was performed which compared 0.55
      (bundled cords) incidence of thermal injury versus 0.23 (unbundled cords) incidence of
      thermal injury. A sample size of 36 per group has the power (1-β) 0.80 to detect a difference
      assuming α=0.05. We estimate a 15% dropout rate (this would be individuals who between their
      consent in pre-operative clinic and their operation decide to withdraw from the study). A 15%
      dropout rate is conservative in light of our prior experience recruiting similar patients
      when 0% (0/40) of individuals dropped out. Total sample size is estimated to be 72 (36 for
      each of two groups) plus 11 (15% dropout) for a total of 84 subjects.

      STATISTICAL ANALYSIS:

      The incidence of thermal injury to the skin (dichotomous variable) in the groups that had
      unbundled or bundled camera/active electrode cords will be compared using the Fischer's exact
      chi squared test.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Histologic Thermal Injury to Umbilical Port Site Skin
time frame: 1 day
description: Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.
measure: Histologic Evidence of Burn at the Epigastric Port Site Skin.
time frame: 1 day
description: Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.
arm group label: Bundling of cords
arm group type: Experimental
description: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
arm group label: Unbundling of cords
arm group type: Experimental
description: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another
intervention type: Other
intervention name: Unbundling of cords
description: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another
arm group label: Unbundling of cords
intervention type: Other
intervention name: Bundling of cords
description: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
arm group label: Bundling of cords
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas N Robinson, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
citation: Willson PD, van der Walt JD, Moxon D, Rogers J. Port site electrosurgical (diathermy) burns during surgical laparoscopy. Surg Endosc. 1997 Jun;11(6):653-4. doi: 10.1007/s004649900414.
PMID: 9171127
citation: Wu MP, Ou CS, Chen SL, Yen EY, Rowbotham R. Complications and recommended practices for electrosurgery in laparoscopy. Am J Surg. 2000 Jan;179(1):67-73. doi: 10.1016/s0002-9610(99)00267-6.
PMID: 10737583
citation: Jones EL, Robinson TN, McHenry JR, Dunn CL, Montero PN, Govekar HR, Stiegmann GV. Radiofrequency energy antenna coupling to common laparoscopic instruments: practical implications. Surg Endosc. 2012 Nov;26(11):3053-7. doi: 10.1007/s00464-012-2312-6. Epub 2012 May 12.
PMID: 22580879
responsible party type: Sponsor
mesh term: Fatigue
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 