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NCT Number: NCT04461171

Enhanced Recovery After Surgery in Extremity Sarcoma

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.

Recruiting

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Joshua M Lawrenz, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced recovery after surgery

Procedure

Undergo an enhanced recovery after surgery program

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Vanderbilt-Ingram Service for Timely Access

CONTACT

[email protected]

800-811-8480

Sponsors and collaborators

Lead sponsor

Joshua Lawrenz

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2020
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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