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Enhanced Recovery After Surgery for Sarcoma

N/A

Recruiting

Led By Joshua Lawrenz, MD

Research Sponsored by Joshua Lawrenz

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma

Be older than 18 years old

Must not have

Non-English speaking patients

Patients treated non-operatively

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will show whether using the ERAS pathway can help patients undergoing surgery for extremity sarcoma recover better.

Who is the study for?

This trial is for adult patients over 17 years old at Vanderbilt University Medical Center who are about to have surgery for suspected sarcoma in an arm or leg. It's open to those who've never taken opioids and those who currently use them. Non-English speakers and patients not having surgery are excluded.

What is being tested?

The study is testing a program called Enhanced Recovery After Surgery (ERAS) specifically designed for people getting surgical treatment for extremity sarcoma, which affects the limbs. The goal is to see if ERAS improves recovery outcomes after their operations.

What are the potential side effects?

Since this trial focuses on a recovery pathway rather than a drug, traditional side effects aren't applicable. However, there may be risks associated with changes in postoperative care protocols that could affect patient comfort or recovery speed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery at Vanderbilt for a suspected sarcoma in my arm or leg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I am being treated without surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical outcomes - length of hospital stay

Clinical outcomes - opioid requirements

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ERASExperimental Treatment1 Intervention

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

Group II: Non-ERAS (Conventional)Active Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enhanced Recovery After Surgery

2021

N/A

~210

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joshua LawrenzLead Sponsor

Joshua Lawrenz, MD5.01 ReviewsPrincipal Investigator - Vanderbilt Medical Center

Vanderbilt-Ingram Cancer Center

5Patient Review

Dr. Smith was very kind and patient with me. They explained everything that was going to happen before they did it, which made me feel more comfortable.