Enhanced Recovery After Surgery for Sarcoma

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Joshua Lawrenz

Disqualifiers: Non-operative treatment, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Research Team

Joshua M Lawrenz, MD

Principal Investigator

Vanderbilt Medical Center

Eligibility Criteria

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 do not speak English.

I am being treated without surgery.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: ERAS Experimental Treatment 1 Intervention

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

Group II: Non-ERAS (Conventional) Active Control 1 Intervention

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

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

Approved in European Union as ERAS for:

• Colorectal surgery
• Gynecologic surgery
• Orthopedic surgery
• Gastrointestinal surgery

Approved in United States as ERAS for:

• Gynecologic surgery
• Orthopedic surgery
• Gastrointestinal surgery
• Surgical oncology

Approved in Canada as ERAS for:

• General surgery
• Orthopedic surgery
• Gastrointestinal surgery

Approved in China as ERAS for:

• Gastrointestinal surgery
• Orthopedic surgery
• Gynecologic surgery

Who Is Running the Clinical Trial?

Joshua Lawrenz

Lead Sponsor

Trials

1

Recruited

120+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Wijk, L., Franzén, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The implementation of an Enhanced Recovery After Surgery (ERAS) protocol in a small rural hospital for colorectal surgery led to a significant reduction in length of stay (LOS) by approximately 2 days compared to matched controls.

Most patients in the ERAS group adhered to the protocol, demonstrating effective self-care practices post-surgery, which contributed to their quicker recovery and earlier mobilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery reduces length of stay after colorectal surgery in a small rural hospital in Ontario. Roldan, HA., Brown, AR., Radey, J., et al.[2023]

This multicenter, observational study aims to evaluate postoperative complications within 30 days after gastric cancer surgery, assessing the effectiveness of Enhanced Recovery After Surgery (ERAS) protocols, with data collected over a 3-month period.

The study will explore the relationship between adherence to the ERAS protocol and postoperative complications, potentially identifying areas for improvement in surgical recovery practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Abad-Motos, A., Ripollés-Melchor, J., Bruna-Esteban, M., et al.[2021]

In a study of 918 patients undergoing lower extremity sarcoma surgery, the overall rate of soft tissue complications within 30 days was found to be 5.7%, indicating a relatively low incidence of immediate postoperative issues.

Significant risk factors for these complications included older age, higher body mass index (BMI), and longer operative times, highlighting the importance of patient assessment before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors associated with 30-day complications following lower extremity sarcoma surgery: A national surgical quality improvement project analysis. Hudson, T., Burke, C., Mullner, D., et al.[2022]

In a study of patients with extremity soft-tissue sarcomas treated at a specialized center, complications were more common in those who underwent secondary flap reconstruction due to inadequate primary wound closure compared to those who had primary flap reconstruction.

The study emphasizes the importance of interdisciplinary collaboration in treating soft-tissue sarcomas and proposes an algorithm for surgical therapy that includes both resection and reconstruction strategies to optimize patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Surgical Therapy of Extremity Soft-Tissue Sarcomas: A Personalized Resection and Reconstruction Algorithm. Osterloh, J., Ludolph, I., Grützmann, R., et al.[2023]

In a study of 32 patients undergoing flap reconstruction after sarcoma resection, those who had immediate reconstruction experienced significantly fewer overall complications (28%) compared to those with delayed reconstruction (100%).

Delayed reconstruction was associated with a higher rate of hematomas (28.6% vs. 0.0%) and other complications, highlighting the importance of timely surgical intervention and close monitoring for patients undergoing delayed procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of delayed versus immediate reconstruction following lower-extremity sarcoma resection. Zhou, S., Azzi, AJ., Safran, T., et al.[2020]

A study involving 15 sarcoma survivors revealed that returning to work (RTW) is often motivated by a desire to distract from their illness and move on from their treatment experiences.

Participants faced challenges in RTW due to lingering effects of their disease and treatment, as well as peer perceptions, highlighting the need for support from health professionals and employers to ease this transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of return to work after treatment for extremital soft tissue or bone sarcoma: Between distraction and leaving the disease behind. Zambrano, SC., Kollár, A., Bernhard, J.[2020]

The study reviewed cases of complex sarcoma resections at a large center, involving 11 patients, and found that early complications occurred in 18% and late complications in 36%, indicating a high morbidity associated with these procedures.

Patients with poor preoperative nutritional status were more likely to experience postoperative complications, highlighting the importance of nutritional assessment in surgical planning for sarcoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GHOST Protocol: Greatest Healing Opportunity for Soft Tissue, a Treatment Paradigm for Complex Sarcoma Reconstruction. Kobraei, EM., Eberlin, KR., Ricci, JA., et al.[2022]

The implementation of an Enhanced Recovery After Surgery (ERAS) program for patients with soft tissue sarcoma significantly reduced wound complications, with only 0.9% experiencing wound dehiscence compared to 13.1% in the non-ERAS group, indicating improved surgical outcomes.

Patients in the ERAS program also had a shorter median hospital stay of 5 days compared to 6 days for those not in the program, along with lower rates of postoperative ileus or obstruction, suggesting enhanced recovery and reduced morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery pathway in patients with soft tissue sarcoma. Lyu, HG., Saadat, LV., Bertagnolli, MM., et al.[2021]

The modified Eilber protocol, a neoadjuvant chemoradiation treatment for extremity soft tissue sarcomas, showed similar local control rates compared to standard adjuvant radiotherapy, with 10% recurrence in the Eilber group versus 15% in the Adjuvant group.

Patients receiving the Eilber protocol experienced significantly lower rates of severe late toxicities (3.4%) compared to those receiving adjuvant radiotherapy (27%), indicating a safer long-term profile for the neoadjuvant approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant chemoradiation (modified Eilber protocol) versus adjuvant radiotherapy in the treatment of extremity soft tissue sarcoma. Lehane, C., Ho, F., Thompson, SR., et al.[2017]

The Soft Tissue and Bone Sarcoma Group has conducted extensive research over 10 years, involving 750 patients in phase III trials and 464 in randomized phase II studies, highlighting their commitment to improving treatment for sarcomas despite their low incidence.

Advancements in surgical techniques for extremity sarcomas have led to better limb preservation while maintaining local control, but challenges remain with systemic metastasis, indicating a need for further research in adjuvant therapies.

NCBI (Pubmed)

pubmed.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. Bramwell, VH., Santoro, A., Rouesse, J., et al.[2019]

A less intensive follow-up protocol (6-monthly visits) for patients with extremity sarcomas did not show a significant decrease in overall survival (OS) compared to more frequent (3-monthly) visits, indicating that less frequent monitoring may be sufficient for patient outcomes.

Imaging with chest radiographs was as effective as CT scans in detecting pulmonary metastasis, suggesting that less expensive imaging methods can be used without negatively impacting patient survival or disease-free survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. Puri, A., Gulia, A., Hawaldar, R., et al.[2022]

Delayed diagnosis significantly contributes to the poor outcomes for patients with sarcomas, highlighting the need for improved patient pathways and clinical guidelines.

Centralizing care in expert centers is crucial for enhancing diagnosis and treatment, as these centers concentrate multidisciplinary expertise that can lead to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of expert centres in the management of sarcomas--a UK perspective. Benson, C., Judson, I.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The introduction of early patient rehabilitation in surgery of soft tissue sarcoma and its impact on post-operative outcome. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. [2018]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. India pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery reduces length of stay after colorectal surgery in a small rural hospital in Ontario. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Risk factors associated with 30-day complications following lower extremity sarcoma surgery: A national surgical quality improvement project analysis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Interdisciplinary Surgical Therapy of Extremity Soft-Tissue Sarcomas: A Personalized Resection and Reconstruction Algorithm. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

A comparison of delayed versus immediate reconstruction following lower-extremity sarcoma resection. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Experiences of return to work after treatment for extremital soft tissue or bone sarcoma: Between distraction and leaving the disease behind. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

GHOST Protocol: Greatest Healing Opportunity for Soft Tissue, a Treatment Paradigm for Complex Sarcoma Reconstruction. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Enhanced recovery after surgery pathway in patients with soft tissue sarcoma. [2021]

12. Australia pubmed.ncbi.nlm.nih.gov

Neoadjuvant chemoradiation (modified Eilber protocol) versus adjuvant radiotherapy in the treatment of extremity soft tissue sarcoma. [2017]

13. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Role of expert centres in the management of sarcomas--a UK perspective. [2022]