Enhanced Recovery After Surgery in Extremity Sarcoma

NCT04461171 | Recruiting

• 1 other identifier: VICC SAR 2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (6)

• Pain scores

  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

  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

  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

  Measured by the number of days in the hospital

  3 months

• Clinical outcomes - opioid requirements

  Measured by the amount of opioids consumed

  3 months

• Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)

  Measured by the number of perioperative complications reported

  3 months

Study Arms (2)

ERAS

EXPERIMENTAL

Administration of a perioperative non-narcotic, multimodal pain management pathway.

Procedure: Enhanced Recovery After Surgery

Non-ERAS (Conventional)

NO INTERVENTION

Administration of a conventional perioperative pain management pathway that consists of both narcotic and non-narcotic pain medications.

Interventions

Enhanced Recovery After Surgery PROCEDURE

Undergo an enhanced recovery after surgery program

ERAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients treated non-operatively
• Non-English speaking patients

Sponsors & Collaborators

• Joshua Lawrenz: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Joshua Lawrenz, MD

  Vanderbilt Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanderbilt-Ingram Service for Timely Access

CONTACT

800-811-8480; cip@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 8, 2020
• Study Start: December 14, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)