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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 belowSelect...
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:Select...
I do not speak English.
Select...
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
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 moreAwards & 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.
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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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My opioid use before surgery varies.I do not speak English.I am being treated without surgery.I had surgery at Vanderbilt for a suspected sarcoma in my arm or leg.I am older than 17 years.
Research Study Groups:
This trial has the following groups:- Group 1: ERAS
- Group 2: Non-ERAS (Conventional)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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