<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/NCT01664806</url>
  </required_header>
  <id_info>
    <org_study_id>09-0049</org_study_id>
    <nct_id>NCT01664806</nct_id>
  </id_info>
  <brief_title>Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin</brief_title>
  <official_title>Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode and Thermal Injury to Tissue Adjacent to Port Sites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy&#xD;
      operation. The appearance of burns are common following laparoscopic cholecystectomy;&#xD;
      particularly at the port site of the active electrode. Willson et al found that 9 out of 19&#xD;
      skin biopsies from the skin adjacent to the port site of the monopolar instrument's active&#xD;
      electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997)&#xD;
      11:653] Authors have speculated that using different generator modes may lead to less&#xD;
      capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support&#xD;
      these speculations.&#xD;
&#xD;
      The investigators hypothesize that capacitive coupling electrosurgical injuries from&#xD;
      monopolar instruments are occurring during laparoscopic cholecystectomy operations. The&#xD;
      investigators hypothesize that use of blend modes will reduce the incidence of capacitive&#xD;
      coupling thermal injuries during laparoscopic operations in comparison to coag modes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SPECIFIC AIM:&#xD;
&#xD;
      Compare incidence of skin burns caused by using coag versus blend monopolar instrument modes&#xD;
      at the active electrode port site (epigastric port), and at the non-active electrode port&#xD;
      sites (umbilical and right abdominal wall).&#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. Histology will be performed by a blinded&#xD;
      pathologist.&#xD;
&#xD;
      POPULATION TO BE ENROLLED:&#xD;
&#xD;
      Subjects undergoing elective laparoscopic cholecystectomy will be recruited in the principle&#xD;
      investigators pre-operative clinic. All 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 coag or blend modes of using standard monopolar electrosurgery instruments.&#xD;
      The randomization process will occur by using a random number generator. A total of 40&#xD;
      subjects will be recruited; 20 subjects per group. Shave skin biopsies will be performed at&#xD;
      the edge of the incisions of the active electrode port, the camera port and the medial&#xD;
      assistant port on the right abdominal wall. The incisions and skin will be otherwise opened&#xD;
      and closed in the routine clinical manor.&#xD;
&#xD;
      STATISTICAL ANALYSIS The incidence of skin burns created using coag or blend modes will be&#xD;
      compared individually at all three port sites using chi-squared or Fisher's exact test where&#xD;
      appropriate. Baseline demographic data (e.g., gender, age, body mass index, operation time,&#xD;
      blood loss, indication for operation and histology) will be compared in the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</primary_completion_date>
  <phase>Phase 3</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Histologic Thermal Injury to 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 primary outcome is histologic evidence of burn at this port sites.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histologic Evidence of Burn at the 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 secondary outcome is histologic evidence of burn at this port site.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Intraoperative Complications</condition>
  <condition>Thermal Injury</condition>
  <condition>Electrocoagulation</condition>
  <arm_group>
    <arm_group_label>Coag mode 30 Watts Power</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Covidien Triad monopolar generator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform Elective laparoscopic cholecystectomy. which is the experimental arm of the study's mode.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Covidien Triad monopolar generator</intervention_name>
    <description>Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.</description>
    <arm_group_label>Covidien Triad monopolar generator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older planned to undergo elective laparoscopic cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing urgent or emergent laparoscopic cholecystectomy operations&#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 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>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>January 25, 2013</results_first_submitted>
  <results_first_submitted_qc>January 25, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 1, 2013</results_first_posted>
  <last_update_submitted>March 18, 2013</last_update_submitted>
  <last_update_submitted_qc>March 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2013</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>Intraoperative Complications</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Burns</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>40 patients were recruited at the University of Colorado Hospital.</recruitment_details>
      <pre_assignment_details>Two screened patients were excluded because they refused entry into the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts</title>
          <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.&#xD;
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.</description>
        </group>
        <group group_id="P2">
          <title>Coag Mode 30 Watts Power</title>
          <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.&#xD;
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </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>Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts</title>
          <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.&#xD;
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.</description>
        </group>
        <group group_id="B2">
          <title>Coag Mode 30 Watts Power</title>
          <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.&#xD;
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy</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="20"/>
            <count group_id="B2" value="20"/>
            <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="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="47" spread="18"/>
                    <measurement group_id="B2" value="41" spread="12"/>
                    <measurement group_id="B3" value="44" spread="15"/>
                  </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="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </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="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Histologic Thermal Injury to Epigastric Port Site Skin</title>
        <description>Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.</description>
        <time_frame>1 day</time_frame>
        <population>A sample size of convenience for feasibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts</title>
            <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.&#xD;
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.</description>
          </group>
          <group group_id="O2">
            <title>Coag Mode 30 Watts Power</title>
            <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.&#xD;
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Histologic Thermal Injury to Epigastric Port Site Skin</title>
          <description>Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.</description>
          <population>A sample size of convenience for feasibility.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Histologic Evidence of Burn at the Umbilical Port Site Skin</title>
        <description>Shave biopsy of skin at the umbilical 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>
        <population>A sample size of convenience for feasibility.</population>
        <group_list>
          <group group_id="O1">
            <title>Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts</title>
            <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.&#xD;
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.</description>
          </group>
          <group group_id="O2">
            <title>Coag Mode 30 Watts Power</title>
            <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.&#xD;
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Histologic Evidence of Burn at the Umbilical Port Site Skin</title>
          <description>Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.</description>
          <population>A sample size of convenience for feasibility.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>No adverse events were discovered.</desc>
      <group_list>
        <group group_id="E1">
          <title>Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts</title>
          <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.&#xD;
Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.</description>
        </group>
        <group group_id="E2">
          <title>Coag Mode 30 Watts Power</title>
          <description>Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.&#xD;
Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy</description>
        </group>
      </group_list>
      <serious_events>
        <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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>
    <limitations_and_caveats>This is a pilot study with no funding so data is limited.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Thomas Robinson</name_or_title>
      <organization>University of Colorado School of Medicine</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/NCT01664806
org study id: 09-0049
nct id: NCT01664806
lead sponsor: 
collaborator: 
has dmc: No
Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy
      operation. The appearance of burns are common following laparoscopic cholecystectomy;
      particularly at the port site of the active electrode. Willson et al found that 9 out of 19
      skin biopsies from the skin adjacent to the port site of the monopolar instrument's active
      electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997)
      11:653] Authors have speculated that using different generator modes may lead to less
      capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support
      these speculations.

      The investigators hypothesize that capacitive coupling electrosurgical injuries from
      monopolar instruments are occurring during laparoscopic cholecystectomy operations. The
      investigators hypothesize that use of blend modes will reduce the incidence of capacitive
      coupling thermal injuries during laparoscopic operations in comparison to coag modes.
SPECIFIC AIM:

      Compare incidence of skin burns caused by using coag versus blend monopolar instrument modes
      at the active electrode port site (epigastric port), and at the non-active electrode port
      sites (umbilical and right abdominal wall).

      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. Histology will be performed by a blinded
      pathologist.

      POPULATION TO BE ENROLLED:

      Subjects undergoing elective laparoscopic cholecystectomy will be recruited in the principle
      investigators 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 coag or blend modes of using standard monopolar electrosurgery instruments.
      The randomization process will occur by using a random number generator. A total of 40
      subjects will be recruited; 20 subjects per group. Shave skin biopsies will be performed at
      the edge of the incisions of the active electrode port, the camera port and the medial
      assistant port on the right abdominal wall. The incisions and skin will be otherwise opened
      and closed in the routine clinical manor.

      STATISTICAL ANALYSIS The incidence of skin burns created using coag or blend modes will be
      compared individually at all three port sites using chi-squared or Fisher's exact test where
      appropriate. Baseline demographic data (e.g., gender, age, body mass index, operation time,
      blood loss, indication for operation and histology) will be compared in the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Histologic Thermal Injury to 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 primary outcome is histologic evidence of burn at this port sites.
measure: Histologic Evidence of Burn at the 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 secondary outcome is histologic evidence of burn at this port site.
arm group label: Coag mode 30 Watts Power
arm group type: No Intervention
description: Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
arm group label: Covidien Triad monopolar generator
arm group type: Experimental
description: Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform Elective laparoscopic cholecystectomy. which is the experimental arm of the study's mode.
intervention type: Device
intervention name: Covidien Triad monopolar generator
description: Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.
arm group label: Covidien Triad monopolar generator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Robinson, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Intraoperative Complications
mesh term: Wounds and Injuries
mesh term: Burns
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This is a pilot study with no funding so data is limited.
point of contact: 