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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
Patients of all preoperative opioid status (naïve or dependent)
Any patient at Vanderbilt University Medical Center treated with surgical excision of a suspected extremity sarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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...
My opioid use before surgery varies.
Select...
I had surgery at Vanderbilt for a suspected sarcoma in my arm or leg.
Select...
I am older than 17 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical outcomes - length of hospital stay
Clinical outcomes - opioid requirements
Clinical outcomes - perioperative complications (e.g. wound complications and 30-day readmission)
+2 moreTrial 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.
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Up to how many participants can this experiment support?
"Yes, the information on clinicaltrials.gov attests that this medical experiment is actively seeking participants. It was initially posted in December 2020 and its most recent update happened July 8th 2022. The investigation requires 120 individuals to be recruited from a single location."
Answered by AI
Are there opportunities to join the trial at this time?
"As indicated on clinicaltrials.gov, the recruitment phase for this trial is ongoing; it was first published on December 14th 2020 and last modified on July 8th 2022."
Answered by AI
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