Enhanced Recovery After Surgery in Extremity Sarcoma

Not Applicable

Recruiting

• Conditions: Sarcoma
• Interventions: Procedure: Enhanced Recovery After Surgery

• Registration Number: NCT04461171
• Lead Sponsor: Joshua Lawrenz

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.

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 Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-08
• Study Start: 2020-12-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ERAS	Enhanced Recovery After Surgery	Administration of a perioperative non-narcotic, multimodal pain management pathway.

Primary Outcome Measures

Name	Time	Method
Pain scores	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)
Clinical outcomes - opioid requirements	3 months	Measured by the amount of opioids consumed
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)	3 months	Measured by the number of perioperative complications reported
Limb function	3 months	Measured by Musculoskeletal Tumor Society scoring system (MSTS) scored from 0-5 (5 being best and 0 being worst)
Clinical outcomes - length of hospital stay	3 months	Measured by the number of days in the hospital

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States