Enhanced Recovery After Surgery in Extremity Sarcoma

July 13, 2023 updated by: Joshua Lawrenz
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vanderbilt-Ingram Service for Timely Access
  • Phone Number: 800-811-8480
  • Email: cip@vumc.org

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Joshua M Lawrenz, MD
        • Contact:
          • Vanderbilt-Ingram Service for Timely Access
          • Phone Number: 800-811-8480
          • Email: cip@vumc.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months
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 months
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)
3 months
Clinical outcomes - length of hospital stay
Time Frame: 3 months
Measured by the number of days in the hospital
3 months
Clinical outcomes - opioid requirements
Time Frame: 3 months
Measured by the amount of opioids consumed
3 months
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
Time Frame: 3 months
Measured by the number of perioperative complications reported
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua Lawrenz

Investigators

  • Principal Investigator: Joshua Lawrenz, MD, Vanderbilt Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC SAR 2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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