<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/NCT04461171</url>
  </required_header>
  <id_info>
    <org_study_id>VICC SAR 2020</org_study_id>
    <nct_id>NCT04461171</nct_id>
  </id_info>
  <brief_title>Enhanced Recovery After Surgery in Extremity Sarcoma</brief_title>
  <official_title>Enhanced Recovery After Surgery in Extremity Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joshua Lawrenz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt-Ingram Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the efficacy of implementing the enhanced&#xD;
      recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical&#xD;
      treatment for extremity sarcoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specifically, the focus of this study will be regarding the administration of a perioperative&#xD;
      non-narcotic, multimodal pain management pathway. Primary endpoints collected with be&#xD;
      short-term patient reported outcomes (pain scores [PROMIS] and [QoR-15]), limb function&#xD;
      scores [MSTS], and key clinical outcomes (hospital length of stay, opioid&#xD;
      requirements/prescribing data and perioperative complications).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Two-group, prospective, consecutively enrolled, comparative non-randomized trial (N = 120) is to determine the feasibility and efficacy of implementing an enhanced recovery after surgery (ERAS) pain management pathway to patients undergoing surgical treatment for an extremity sarcoma.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain scores</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Limb function</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical outcomes - length of hospital stay</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by the number of days in the hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical outcomes - opioid requirements</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by the amount of opioids consumed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by the number of perioperative complications reported</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>ERAS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of a perioperative non-narcotic, multimodal pain management pathway.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-ERAS (Conventional)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Enhanced Recovery After Surgery</intervention_name>
    <description>Undergo an enhanced recovery after surgery program</description>
    <arm_group_label>ERAS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient at Vanderbilt University Medical Center treated with surgical excision of&#xD;
             a suspected extremity sarcoma&#xD;
&#xD;
          -  Adult patients &gt;17 years of age&#xD;
&#xD;
          -  Patients of all preoperative opioid status (naïve or dependent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated non-operatively&#xD;
&#xD;
          -  Non-English speaking patients&#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>Joshua Lawrenz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vanderbilt-Ingram Service for Timely Access</last_name>
    <phone>800-811-8480</phone>
    <email>cip@vumc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanderbilt-Ingram Service for Timely Access</last_name>
      <phone>800-811-8480</phone>
      <email>cip@vumc.org</email>
    </contact>
    <investigator>
      <last_name>Joshua M Lawrenz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 13, 2023</last_update_submitted>
  <last_update_submitted_qc>July 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
    <investigator_full_name>Joshua Lawrenz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Enhanced Recovery After Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04461171
org study id: VICC SAR 2020
nct id: NCT04461171
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to demonstrate the efficacy of implementing the enhanced
      recovery after surgery (ERAS) pathway in a prospective manner to patients undergoing surgical
      treatment for extremity sarcoma.
Specifically, the focus of this study will be regarding the administration of a perioperative
      non-narcotic, multimodal pain management pathway. Primary endpoints collected with be
      short-term patient reported outcomes (pain scores [PROMIS] and [QoR-15]), limb function
      scores [MSTS], and key clinical outcomes (hospital length of stay, opioid
      requirements/prescribing data and perioperative complications).
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Two-group, prospective, consecutively enrolled, comparative non-randomized trial (N = 120) is to determine the feasibility and efficacy of implementing an enhanced recovery after surgery (ERAS) pain management pathway to patients undergoing surgical treatment for an extremity sarcoma.
primary purpose: Treatment
masking: None (Open Label)
measure: Pain scores
time frame: 3 months
description: Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)
measure: Pain scores
time frame: 3 months
description: Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best)
measure: Limb function
time frame: 3 months
description: Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)
measure: Clinical outcomes - length of hospital stay
time frame: 3 months
description: Measured by the number of days in the hospital
measure: Clinical outcomes - opioid requirements
time frame: 3 months
description: Measured by the amount of opioids consumed
measure: Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
time frame: 3 months
description: Measured by the number of perioperative complications reported
arm group label: ERAS
arm group type: Experimental
description: Administration of a perioperative non-narcotic, multimodal pain management pathway.
arm group label: Non-ERAS (Conventional)
arm group type: No Intervention
description: Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.
intervention type: Procedure
intervention name: Enhanced Recovery After Surgery
description: Undergo an enhanced recovery after surgery program
arm group label: ERAS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joshua Lawrenz, MD
role: Principal Investigator
affiliation: Vanderbilt Medical Center
last name: Vanderbilt-Ingram Service for Timely Access
phone: 800-811-8480
email: cip@vumc.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Vanderbilt-Ingram Cancer Center
investigator full name: Joshua Lawrenz
investigator title: Principal Investigator
mesh term: Sarcoma
sharing ipd: No