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Clinical Trials/NCT04461171
NCT04461171
Recruiting
Not Applicable

Enhanced Recovery After Surgery in Extremity Sarcoma

Joshua Lawrenz1 site in 1 country120 target enrollmentDecember 14, 2020
ConditionsSarcoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcoma
Sponsor
Joshua Lawrenz
Enrollment
120
Locations
1
Primary Endpoint
Pain scores
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 14, 2020
End Date
June 2026
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Joshua Lawrenz
Responsible Party
Sponsor Investigator
Principal Investigator

Joshua Lawrenz

Principal Investigator

Vanderbilt-Ingram Cancer Center

Eligibility 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

Outcomes

Primary Outcomes

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)

Clinical outcomes - opioid requirements

Time Frame: 3 months

Measured by the amount of opioids consumed

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

Time Frame: 3 months

Measured by the number of perioperative complications reported

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)

Clinical outcomes - length of hospital stay

Time Frame: 3 months

Measured by the number of days in the hospital

Study Sites (1)

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