<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/NCT01705288</url>
  </required_header>
  <id_info>
    <org_study_id>2012LS096</org_study_id>
    <nct_id>NCT01705288</nct_id>
  </id_info>
  <brief_title>Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study</brief_title>
  <official_title>Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masonic Cancer Center, University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over 600,000 hysterectomies are performed annually in the United States. Despite increasing&#xD;
      use of less invasive approaches, the majority of hysterectomies are still performed via&#xD;
      traditional laparotomy, which can be associated with generally slower recovery and longer&#xD;
      lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize&#xD;
      post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as&#xD;
      possible following surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional&#xD;
      anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs&#xD;
      (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or&#xD;
      standard of care (traditional laparatomy and supportive care).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">August 24, 2016</completion_date>
  <primary_completion_date type="Actual">August 24, 2016</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Stay</measure>
    <time_frame>1 Month</time_frame>
    <description>Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Medications Used</measure>
    <time_frame>Post operative - day 2</time_frame>
    <description>Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Assessment</measure>
    <time_frame>Day 0</time_frame>
    <description>Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Uterine Endometrial Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Control Group (Standard Laparotomy)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rapid Recovery Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Protocol for &quot;rapid recovery laparotomy&quot; procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparotomy</intervention_name>
    <description>Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital</description>
    <arm_group_label>Control Group (Standard Laparotomy)</arm_group_label>
    <arm_group_label>Rapid Recovery Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intravenous narcotics</intervention_name>
    <description>given for pain management after surgery per physician orders</description>
    <arm_group_label>Control Group (Standard Laparotomy)</arm_group_label>
    <other_name>morphine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>standard anesthesia</intervention_name>
    <description>inhalant or intravenous during surgery</description>
    <arm_group_label>Control Group (Standard Laparotomy)</arm_group_label>
    <other_name>general anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>regional anesthesia</intervention_name>
    <description>given by spinal or epidural infusion</description>
    <arm_group_label>Rapid Recovery Group</arm_group_label>
    <other_name>local anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Non-steroidal anti-inflammatory drugs</intervention_name>
    <description>given for pain management after surgery</description>
    <arm_group_label>Rapid Recovery Group</arm_group_label>
    <other_name>NSAIDs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are being seen at the Women's Health Center by the Gynecologic Oncology&#xD;
             group at the University of Minnesota if planned surgery includes an exploratory&#xD;
             laparotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 19 years old&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Undergoing a procedure other than laparotomy&#xD;
&#xD;
          -  Scheduled to be discharged the same day of surgery&#xD;
&#xD;
          -  Chronic narcotic pain medication user&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score of &gt; or = 3&#xD;
&#xD;
          -  Any condition that would exclude women from undergoing regional anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Argenta, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masonic Cancer Center, University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Masonic Cancer Center, University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>February 4, 2020</results_first_submitted>
  <results_first_submitted_qc>February 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2020</results_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laparotomy</keyword>
  <keyword>hysterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Inflammatory Agents</mesh_term>
    <mesh_term>Anti-Inflammatory Agents, Non-Steroidal</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Narcotics</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Group (Standard Laparotomy)</title>
          <description>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
intravenous narcotics: given for pain management after surgery per physician orders&#xD;
standard anesthesia: inhalant or intravenous during surgery</description>
        </group>
        <group group_id="P2">
          <title>Rapid Recovery Group</title>
          <description>Protocol for &quot;rapid recovery laparotomy&quot; procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
regional anesthesia: given by spinal or epidural infusion&#xD;
Non-steroidal anti-inflammatory drugs: given for pain management after surgery</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="51"/>
              </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>Control Group (Standard Laparotomy)</title>
          <description>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
intravenous narcotics: given for pain management after surgery per physician orders&#xD;
standard anesthesia: inhalant or intravenous during surgery</description>
        </group>
        <group group_id="B2">
          <title>Rapid Recovery Group</title>
          <description>Protocol for &quot;rapid recovery laparotomy&quot; procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
regional anesthesia: given by spinal or epidural infusion&#xD;
Non-steroidal anti-inflammatory drugs: given for pain management after surgery</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="52"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="103"/>
          </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="52"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.0" lower_limit="52.8" upper_limit="59.2"/>
                    <measurement group_id="B2" value="55.4" lower_limit="52.3" upper_limit="58.5"/>
                    <measurement group_id="B3" value="55.65" lower_limit="52.8" upper_limit="58.5"/>
                  </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="52"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>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="52"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hospital Stay</title>
        <description>Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge</description>
        <time_frame>1 Month</time_frame>
        <population>Individuals randomized who underwent eligible surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group (Standard Laparotomy)</title>
            <description>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
intravenous narcotics: given for pain management after surgery per physician orders&#xD;
standard anesthesia: inhalant or intravenous during surgery</description>
          </group>
          <group group_id="O2">
            <title>Rapid Recovery Group</title>
            <description>Protocol for &quot;rapid recovery laparotomy&quot; procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
regional anesthesia: given by spinal or epidural infusion&#xD;
Non-steroidal anti-inflammatory drugs: given for pain management after surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Stay</title>
          <description>Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge</description>
          <population>Individuals randomized who underwent eligible surgery</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intention to Treat Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.36</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Medications Used</title>
        <description>Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.</description>
        <time_frame>Post operative - day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group (Standard Laparotomy)</title>
            <description>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
intravenous narcotics: given for pain management after surgery per physician orders&#xD;
standard anesthesia: inhalant or intravenous during surgery</description>
          </group>
          <group group_id="O2">
            <title>Rapid Recovery Group</title>
            <description>Protocol for &quot;rapid recovery laparotomy&quot; procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
regional anesthesia: given by spinal or epidural infusion&#xD;
Non-steroidal anti-inflammatory drugs: given for pain management after surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Medications Used</title>
          <description>Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.</description>
          <units>Morphine equivalents</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="8.3" upper_limit="12.3"/>
                    <measurement group_id="O2" value="7.5" lower_limit="3.3" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intention to Treat Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Assessment</title>
        <description>Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.</description>
        <time_frame>Day 0</time_frame>
        <population>Measured in early patients only</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group (Standard Laparotomy)</title>
            <description>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
intravenous narcotics: given for pain management after surgery per physician orders&#xD;
standard anesthesia: inhalant or intravenous during surgery</description>
          </group>
          <group group_id="O2">
            <title>Rapid Recovery Group</title>
            <description>Protocol for &quot;rapid recovery laparotomy&quot; procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
regional anesthesia: given by spinal or epidural infusion&#xD;
Non-steroidal anti-inflammatory drugs: given for pain management after surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Assessment</title>
          <description>Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.</description>
          <population>Measured in early patients only</population>
          <units>Score on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" lower_limit="3.0" upper_limit="6.25"/>
                    <measurement group_id="O2" value="3.13" lower_limit="2.30" upper_limit="4.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control Group (Standard Laparotomy)</title>
          <description>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
intravenous narcotics: given for pain management after surgery per physician orders&#xD;
standard anesthesia: inhalant or intravenous during surgery</description>
        </group>
        <group group_id="E2">
          <title>Rapid Recovery Group</title>
          <description>Protocol for &quot;rapid recovery laparotomy&quot; procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.&#xD;
Laparotomy: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital&#xD;
regional anesthesia: given by spinal or epidural infusion&#xD;
Non-steroidal anti-inflammatory drugs: given for pain management after surgery</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="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ICU admission</sub_title>
                <description>The reason behind ICU admission is not recorded/details not available</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
              </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="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Individual adverse events breakup not known</sub_title>
                <description>Only the counts of adverse events were available. The details of each adverse events data not available</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Peter Argenta</name_or_title>
      <organization>Masonic Cancer Center at University of Minnesota</organization>
      <phone>612-626-6283</phone>
      <email>argenta@umn.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/NCT01705288
org study id: 2012LS096
nct id: NCT01705288
lead sponsor: 
has dmc: Yes
Over 600,000 hysterectomies are performed annually in the United States. Despite increasing
      use of less invasive approaches, the majority of hysterectomies are still performed via
      traditional laparotomy, which can be associated with generally slower recovery and longer
      lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize
      post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as
      possible following surgery.
Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional
      anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs
      (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or
      standard of care (traditional laparatomy and supportive care).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Hospital Stay
time frame: 1 Month
description: Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
measure: Pain Medications Used
time frame: Post operative - day 2
description: Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.
measure: Pain Assessment
time frame: Day 0
description: Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.
arm group label: Control Group (Standard Laparotomy)
arm group type: Active Comparator
description: Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
arm group label: Rapid Recovery Group
arm group type: Experimental
description: Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
intervention type: Procedure
intervention name: Laparotomy
description: Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital
arm group label: Control Group (Standard Laparotomy)
arm group label: Rapid Recovery Group
intervention type: Drug
intervention name: intravenous narcotics
description: given for pain management after surgery per physician orders
arm group label: Control Group (Standard Laparotomy)
other name: morphine
intervention type: Drug
intervention name: standard anesthesia
description: inhalant or intravenous during surgery
arm group label: Control Group (Standard Laparotomy)
other name: general anesthesia
intervention type: Drug
intervention name: regional anesthesia
description: given by spinal or epidural infusion
arm group label: Rapid Recovery Group
other name: local anesthesia
intervention type: Drug
intervention name: Non-steroidal anti-inflammatory drugs
description: given for pain management after surgery
arm group label: Rapid Recovery Group
other name: NSAIDs
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Argenta, M.D.
role: Principal Investigator
affiliation: Masonic Cancer Center, University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Anti-Inflammatory Agents
mesh term: Anti-Inflammatory Agents, Non-Steroidal
mesh term: Morphine
mesh term: Narcotics
mesh term: Anesthetics
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 