<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/NCT01667848</url>
  </required_header>
  <id_info>
    <org_study_id>LCHE0909</org_study_id>
    <nct_id>NCT01667848</nct_id>
  </id_info>
  <brief_title>Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy</brief_title>
  <official_title>Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig Boltzmann Institute for Operative Laparoscopy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig Boltzmann Institute for Operative Laparoscopy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of warmed, humidified carbon dioxide&#xD;
      Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing warmed, humidified carbon dioxide (CO2) insufflation for laparoscopic&#xD;
      cholecystectomy will have less postoperative pain than patients undergoing laparoscopic&#xD;
      cholecystectomy with standard CO2 insufflation. The study design is a double-blind,&#xD;
      prospective, randomized study comparing patients undergoing laparoscopic cholecystectomy with&#xD;
      standard CO2 insufflation vs those receiving warmed, humidified CO2. Main variables included&#xD;
      postoperative pain (rated with a visual analog scales) and analgesic requirements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain (Rated With a Visual Analog Scale for Pain)</measure>
    <time_frame>operation day</time_frame>
    <description>postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.&#xD;
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain (Rated With a Visual Analog Scale for Pain)</measure>
    <time_frame>first postoperative day</time_frame>
    <description>postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.&#xD;
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Core Temperature</measure>
    <time_frame>one day postoperativly</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Temperature</measure>
    <time_frame>during operation</time_frame>
    <description>core temperature during laparoscopic cholecystectomy using a rectal probe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Cholecystolithiasis</condition>
  <arm_group>
    <arm_group_label>group B: Insufflation with warm gas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insufflation with warmed, humidified carbon dioxide insufflation during laparoscopic cholecystectomy using the optitherm® device attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group A: Insufflation with cold gas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group A: Insufflation with cold gas during laparoscopic cholecystectomy, the use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optitherm® device activated</intervention_name>
    <description>The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.</description>
    <arm_group_label>group B: Insufflation with warm gas</arm_group_label>
    <other_name>Optitherm® device (Storz, Tuttlingen, Germany)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optitherm® device inactivated</intervention_name>
    <description>The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.</description>
    <arm_group_label>group A: Insufflation with cold gas</arm_group_label>
    <other_name>Optitherm® device (Storz, Tuttlingen, Germany)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of cholecystolithiasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of cholecystolithiasis with cholecystitis&#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>Andreas Shamiyeh, Univ-Doz Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>2nd Surgical Department, Academic Teaching Hospital, AKH Linz</name>
      <address>
        <city>Linz</city>
        <state>Upper Austria</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Farley DR, Greenlee SM, Larson DR, Harrington JR. Double-blind, prospective, randomized study of warmed, humidified carbon dioxide insufflation vs standard carbon dioxide for patients undergoing laparoscopic cholecystectomy. Arch Surg. 2004 Jul;139(7):739-43; discussion 743-4. doi: 10.1001/archsurg.139.7.739.</citation>
    <PMID>15249406</PMID>
  </reference>
  <reference>
    <citation>Sammour T, Kahokehr A, Hill AG. Meta-analysis of the effect of warm humidified insufflation on pain after laparoscopy. Br J Surg. 2008 Aug;95(8):950-6. doi: 10.1002/bjs.6304.</citation>
    <PMID>18618870</PMID>
  </reference>
  <reference>
    <citation>Yu TC, Hamill JK, Liley A, Hill AG. Warm, humidified carbon dioxide gas insufflation for laparoscopic appendicectomy in children: a double-blinded randomized controlled trial. Ann Surg. 2013 Jan;257(1):44-53. doi: 10.1097/SLA.0b013e31825f0721.</citation>
    <PMID>22824858</PMID>
  </reference>
  <reference>
    <citation>Nguyen NT, Furdui G, Fleming NW, Lee SJ, Goldman CD, Singh A, Wolfe BM. Effect of heated and humidified carbon dioxide gas on core temperature and postoperative pain: a randomized trial. Surg Endosc. 2002 Jul;16(7):1050-4. doi: 10.1007/s00464-001-8237-0. Epub 2002 Mar 26.</citation>
    <PMID>12165821</PMID>
  </reference>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>July 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>September 30, 2013</results_first_submitted>
  <results_first_submitted_qc>March 30, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 30, 2014</results_first_posted>
  <last_update_submitted>May 4, 2014</last_update_submitted>
  <last_update_submitted_qc>May 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig Boltzmann Institute for Operative Laparoscopy</investigator_affiliation>
    <investigator_full_name>Klugsberger Bettina</investigator_full_name>
    <investigator_title>Dr.med</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Approval from the local institutional ethics committee was obtained on June 2011. Between July 1st, 2011 and December 28nd, 2013, a total of 148 patients were scheduled for laparoscopic cholecystectomy at the General Hospital in Linz, Austria</recruitment_details>
      <pre_assignment_details>Patients converted intraoperative to open cholecystectomy or those undergoing a concomitant procedure were excluded from the study. Irregularities of the study protocol (absence of rectal probe, missing consent form, conversion to open cholecystectomy) entailed in exclusion of the study. Patients with acute cholecystitis were excluded of the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A: Insufflation With Cold Gas</title>
          <description>Insufflation with cold gas during laparoskopic cholecystectomy</description>
        </group>
        <group group_id="P2">
          <title>Group B: Insufflation With Warm Gas</title>
          <description>Insufflation with warm gas during 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="67"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="81"/>
              </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>Group A: Insufflation With Cold Gas</title>
          <description>Insufflation with cold gas during laparoskopic cholecystectomy</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>Insufflation with warm gas during laparoskopic 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="67"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="148"/>
          </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="55.87" spread="14.44"/>
                    <measurement group_id="B2" value="55.68" spread="16.93"/>
                    <measurement group_id="B3" value="55.7" spread="15.14"/>
                  </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="46"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </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>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain (Rated With a Visual Analog Scale for Pain)</title>
        <description>postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.&#xD;
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)</description>
        <time_frame>operation day</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Temperature</title>
        <time_frame>one day postoperativly</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain (Rated With a Visual Analog Scale for Pain)</title>
        <description>postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.&#xD;
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)</description>
        <time_frame>first postoperative day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A: Insufflation With Cold Gas</title>
            <description>Insufflation with cold gas during laparoskopic cholecystectomy</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Insufflation with warm gas during laparoskopic cholecystectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Pain (Rated With a Visual Analog Scale for Pain)</title>
          <description>postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.&#xD;
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)</description>
          <units>units on a scale 0-10</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="0.97"/>
                    <measurement group_id="O2" value="1.92" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Temperature</title>
        <description>core temperature during laparoscopic cholecystectomy using a rectal probe</description>
        <time_frame>during operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A: Insufflation With Cold Gas</title>
            <description>Insufflation with cold gas during laparoskopic cholecystectomy</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Insufflation with warm gas during laparoskopic cholecystectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Core Temperature</title>
          <description>core temperature during laparoscopic cholecystectomy using a rectal probe</description>
          <units>degree celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.85" spread="0.46"/>
                    <measurement group_id="O2" value="37.07" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Group A</title>
          <description>Insufflation with cold gas during laparoscopic cholecystectomy</description>
        </group>
        <group group_id="E2">
          <title>Group B</title>
          <description>Insufflation with warm gas during 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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </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>Dr. Bettina Klugsberger</name_or_title>
      <organization>LudwigBoltzmannIOL</organization>
      <phone>+43 732 7806 2133</phone>
      <email>Bettina.Klugsberger@akh.linz.at</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/NCT01667848
org study id: LCHE0909
nct id: NCT01667848
lead sponsor: 
has dmc: No
The purpose of this study is to determine the effect of warmed, humidified carbon dioxide
      Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.
Patients undergoing warmed, humidified carbon dioxide (CO2) insufflation for laparoscopic
      cholecystectomy will have less postoperative pain than patients undergoing laparoscopic
      cholecystectomy with standard CO2 insufflation. The study design is a double-blind,
      prospective, randomized study comparing patients undergoing laparoscopic cholecystectomy with
      standard CO2 insufflation vs those receiving warmed, humidified CO2. Main variables included
      postoperative pain (rated with a visual analog scales) and analgesic requirements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pain (Rated With a Visual Analog Scale for Pain)
time frame: operation day
description: postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)
measure: Pain (Rated With a Visual Analog Scale for Pain)
time frame: first postoperative day
description: postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.
The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)
measure: Core Temperature
time frame: one day postoperativly
measure: Core Temperature
time frame: during operation
description: core temperature during laparoscopic cholecystectomy using a rectal probe
arm group label: group B: Insufflation with warm gas
arm group type: Experimental
description: Insufflation with warmed, humidified carbon dioxide insufflation during laparoscopic cholecystectomy using the optitherm® device attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.
arm group label: group A: Insufflation with cold gas
arm group type: Experimental
description: group A: Insufflation with cold gas during laparoscopic cholecystectomy, the use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A
intervention type: Device
intervention name: Optitherm® device activated
description: The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.
arm group label: group B: Insufflation with warm gas
other name: Optitherm® device (Storz, Tuttlingen, Germany)
intervention type: Device
intervention name: Optitherm® device inactivated
description: The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.
arm group label: group A: Insufflation with cold gas
other name: Optitherm® device (Storz, Tuttlingen, Germany)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Shamiyeh, Univ-Doz Dr
role: Study Chair
affiliation: Ludwig Boltzmann Institute for Operative Laparoscopy, 2nd Surgical Department, Academic Teaching Hospital, AKH Linz
facility: 
country: Austria
citation: Farley DR, Greenlee SM, Larson DR, Harrington JR. Double-blind, prospective, randomized study of warmed, humidified carbon dioxide insufflation vs standard carbon dioxide for patients undergoing laparoscopic cholecystectomy. Arch Surg. 2004 Jul;139(7):739-43; discussion 743-4. doi: 10.1001/archsurg.139.7.739.
PMID: 15249406
citation: Sammour T, Kahokehr A, Hill AG. Meta-analysis of the effect of warm humidified insufflation on pain after laparoscopy. Br J Surg. 2008 Aug;95(8):950-6. doi: 10.1002/bjs.6304.
PMID: 18618870
citation: Yu TC, Hamill JK, Liley A, Hill AG. Warm, humidified carbon dioxide gas insufflation for laparoscopic appendicectomy in children: a double-blinded randomized controlled trial. Ann Surg. 2013 Jan;257(1):44-53. doi: 10.1097/SLA.0b013e31825f0721.
PMID: 22824858
citation: Nguyen NT, Furdui G, Fleming NW, Lee SJ, Goldman CD, Singh A, Wolfe BM. Effect of heated and humidified carbon dioxide gas on core temperature and postoperative pain: a randomized trial. Surg Endosc. 2002 Jul;16(7):1050-4. doi: 10.1007/s00464-001-8237-0. Epub 2002 Mar 26.
PMID: 12165821
responsible party type: Principal Investigator
investigator affiliation: Ludwig Boltzmann Institute for Operative Laparoscopy
investigator full name: Klugsberger Bettina
investigator title: Dr.med
mesh term: Cholecystolithiasis
mesh term: Cholelithiasis
mesh term: Gallstones
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 