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Enhanced Recovery After Surgery in Extremity Sarcoma

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ClinicalTrials.gov Identifier: NCT04461171
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
Joshua Lawrenz, Vanderbilt-Ingram Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sarcoma Procedure: Enhanced Recovery After Surgery Not Applicable

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Surgery in Extremity Sarcoma
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ERAS
Administration of a perioperative non-narcotic, multimodal pain management pathway.
 Procedure: Enhanced Recovery After Surgery
Undergo an enhanced recovery after surgery program
No Intervention: Non-ERAS (Conventional)
Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.


Outcome Measures
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Primary Outcome Measures :
  1. Pain scores [ Time Frame: 3 months ]
    Measured by Quality of Recovery questionnaire (QoR-15) scale = 0-10 (0=none of the time and 10 = all of the time)

  2. Pain scores [ Time Frame: 3 months ]
    Measured by Patient-Reported Outcomes Measurement Information System (PROMIS-29 Profile v2.0) Score 1-5 (1 being worst and 5 being best)

  3. Limb function [ Time Frame: 3 months ]
    Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)

  4. Clinical outcomes - length of hospital stay [ Time Frame: 3 months ]
    Measured by the number of days in the hospital

  5. Clinical outcomes - opioid requirements [ Time Frame: 3 months ]
    Measured by the amount of opioids consumed

  6. Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission) [ Time Frame: 3 months ]
    Measured by the number of perioperative complications reported


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma
  • Adult patients >17 years of age
  • Patients of all preoperative opioid status (naïve or dependent)

Exclusion Criteria:

  • Patients treated non-operatively
  • Non-English speaking patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461171


Contacts
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Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Service for Timely Access    800-811-8480    cip@vumc.org   
Principal Investigator: Joshua M Lawrenz, MD         
Sponsors and Collaborators
Joshua Lawrenz
Investigators
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Principal Investigator: Joshua Lawrenz, MD Vanderbilt Medical Center
More Information
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Responsible Party: Joshua Lawrenz, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04461171    
Other Study ID Numbers: VICC SAR 2020
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua Lawrenz, Vanderbilt-Ingram Cancer Center:
Enhanced Recovery After Surgery
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms