120 Participants Needed

Enhanced Recovery After Surgery for Sarcoma

VS
Overseen ByVanderbilt-Ingram Service for Timely Access
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Joshua Lawrenz
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Enhanced Recovery After Surgery (ERAS) generally safe for humans?

The research articles provided do not contain specific safety data for Enhanced Recovery After Surgery (ERAS) or similar protocols like Enhanced Recovery Protocol or Fast-Track Protocol. They focus on surgical complications and reconstruction strategies for sarcoma, but do not address the safety of ERAS protocols.12345

How is the Enhanced Recovery After Surgery (ERAS) treatment different for sarcoma patients?

The Enhanced Recovery After Surgery (ERAS) treatment is unique because it is a comprehensive program designed to improve recovery after surgery by using a combination of strategies, such as optimizing nutrition, pain management, and mobilization, tailored specifically for patients with soft tissue sarcoma. This approach differs from traditional methods by focusing on enhancing overall recovery rather than just treating the sarcoma itself.678910

What data supports the effectiveness of the treatment Enhanced Recovery After Surgery (ERAS) for sarcoma?

Research shows that ERAS programs, which help patients recover faster after surgery, have been effective in reducing hospital stay and improving recovery in surgeries for conditions like colorectal and gastric cancer. This suggests that similar benefits might be seen when ERAS is used for sarcoma surgery.1112131415

Who Is on the Research Team?

JL

Joshua M Lawrenz, MD

Principal Investigator

Vanderbilt Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My opioid use before surgery varies.
I had surgery at Vanderbilt for a suspected sarcoma in my arm or leg.
I am older than 17 years.

Exclusion Criteria

I am being treated without surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

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

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores, limb function, and clinical outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Recovery After Surgery
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ERASExperimental Treatment1 Intervention
Group II: Non-ERAS (Conventional)Active Control1 Intervention

Enhanced Recovery After Surgery is already approved in European Union, United States, Canada, China for the following indications:

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Approved in European Union as ERAS for:
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Approved in United States as ERAS for:
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Approved in Canada as ERAS for:
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Approved in China as ERAS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joshua Lawrenz

Lead Sponsor

Trials
1
Recruited
120+

Published Research Related to This Trial

The introduction of Enhanced Recovery After Surgery (ERAS) protocols in soft-tissue sarcoma (STS) surgery significantly reduced hospital stays from an average of 9 days to 3 days without increasing major complications or readmissions, indicating improved postoperative recovery.
ERAS implementation led to a notable decrease in wound drainage and an increase in wound bandaging, suggesting effective perioperative management, while maintaining similar rates of tumor control and local recurrence compared to standard recovery methods.
The introduction of early patient rehabilitation in surgery of soft tissue sarcoma and its impact on post-operative outcome.Michot, A., Stoeckle, E., Bannel, JD., et al.[2015]
The ERAS protocol implemented in gynecological surgery showed no significant difference in length of stay (LOS) between patients undergoing hysterectomy for malignant (2 days) versus benign (2 days) conditions, indicating its effectiveness for both groups.
Patients with malignant and benign conditions had similar rates of complications, reoperations, and readmissions, suggesting that the ERAS protocol is safe and beneficial for enhancing recovery regardless of the nature of the disease.
Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease.Wijk, L., FranzΓ©n, K., Ljungqvist, O., et al.[2018]
The ERAS protocol aims to enhance recovery after colorectal cancer surgery and is being tested in a large multicenter trial involving 2200 patients across 28 surgical centers in Piemonte, Italy, to assess its impact on hospital stay length and postoperative outcomes.
The study will compare standard care with the ERAS protocol, monitoring adherence and outcomes like recovery time and patient satisfaction, with a high statistical power of 98% to detect meaningful changes.
Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project.Pagano, E., Pellegrino, L., Rinaldi, F., et al.[2021]

Citations

The introduction of early patient rehabilitation in surgery of soft tissue sarcoma and its impact on post-operative outcome. [2015]
Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. [2018]
Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project. [2021]
Enhanced recovery after surgery reduces length of stay after colorectal surgery in a small rural hospital in Ontario. [2023]
Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. [2021]
Risk factors associated with 30-day complications following lower extremity sarcoma surgery: A national surgical quality improvement project analysis. [2022]
Interdisciplinary Surgical Therapy of Extremity Soft-Tissue Sarcomas: A Personalized Resection and Reconstruction Algorithm. [2023]
A comparison of delayed versus immediate reconstruction following lower-extremity sarcoma resection. [2020]
Experiences of return to work after treatment for extremital soft tissue or bone sarcoma: Between distraction and leaving the disease behind. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
GHOST Protocol: Greatest Healing Opportunity for Soft Tissue, a Treatment Paradigm for Complex Sarcoma Reconstruction. [2022]
Enhanced recovery after surgery pathway in patients with soft tissue sarcoma. [2021]
Neoadjuvant chemoradiation (modified Eilber protocol) versus adjuvant radiotherapy in the treatment of extremity soft tissue sarcoma. [2017]
13.United Statespubmed.ncbi.nlm.nih.gov
Review of the clinical trials activity of the Soft Tissue and Bone Sarcoma Group of the European Organization for Research and Treatment of Cancer. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. [2022]
Role of expert centres in the management of sarcomas--a UK perspective. [2022]
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