Enhanced Recovery After Surgery for Sarcoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Joshua Lawrenz
Disqualifiers: Non-operative treatment, Non-English speaking
No Placebo Group
Approved in 4 Jurisdictions
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
Joshua LawrenzLead Sponsor
References
The introduction of early patient rehabilitation in surgery of soft tissue sarcoma and its impact on post-operative outcome. [2015]Enhanced recovery after surgery (ERAS) programs are implemented in multiple fields of surgery, but not yet in soft-tissue sarcoma (STS) surgery. We wondered whether its introduction into STS surgery might have impacted postoperative outcome.
Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. [2018]The enhanced recovery after surgery (ERAS) protocol combines unimodal evidence-based interventions aiming to enhance recovery after surgery and reduce length of stay (LOS). We introduced an ERAS protocol in gynecological surgery and compared outcomes after hysterectomies performed for malignant vs. benign indications.
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]The ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population.
Enhanced recovery after surgery reduces length of stay after colorectal surgery in a small rural hospital in Ontario. [2023]Enhanced recovery after surgery (ERAS) programmes include pre-operative, intraoperative and post-operative clinical pathways to improve quality of patient care while reducing length of stay (LOS) and readmission. This study assessed the feasibility and outcomes of an ERAS protocol for colorectal surgery implemented over 2 years in a small, resource-challenged rural hospital.
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]Enhanced recovery pathways or ERAS have been applied in gastric cancer surgery extrapolated from colorectal surgery. The objective of the study is to assess postoperative complications 30 days after gastric surgery for cancer, with any level of compliance with the ERAS protocol. The secondary objectives are to assess 30-day mortality, the relationship between adherence to the ERAS protocol and complications, the impact of each of the items of the protocol on postoperative complications and hospital stay, and to describe the impact of complications on length of hospital stay.
Risk factors associated with 30-day complications following lower extremity sarcoma surgery: A national surgical quality improvement project analysis. [2022]Our study aims to identify risk factors associated with complications in lower extremity (LE) sarcoma surgery, as well as the prevalence and complications associated with concurrent plastic surgery procedures (CPSP).
Interdisciplinary Surgical Therapy of Extremity Soft-Tissue Sarcomas: A Personalized Resection and Reconstruction Algorithm. [2023]Soft-tissue sarcomas (STS) are rare, but potentially life-threatening malignancies. STS can occur anywhere in the human body with the limbs being the most common site. Referral to a specialized sarcoma center is crucial to guarantee prompt and appropriate treatment. STS treatment strategies should be discussed in an interdisciplinary tumor board to involve expertise from all available resources, including an experienced reconstructive surgeon for an optimal outcome. In many cases, extensive resection is needed to achieve R0 resection, resulting in large defects after surgery. Hence, an evaluation of whether plastic reconstruction might be required is mandatory to avoid complications due to insufficient primary wound closure. In this retrospective observational study, we present data of patients with extremity STS treated at the Sarcoma Center, University Hospital Erlangen, in 2021. We found that complications were more frequent in patients who received secondary flap reconstruction after insufficient primary wound closure compared to patients who received primary flap reconstruction. Additionally, we propose an algorithm for an interdisciplinary surgical therapy of soft-tissue sarcomas regarding resection and reconstruction and present two problematic cases to emphasize the complexity of surgical sarcoma therapy.
A comparison of delayed versus immediate reconstruction following lower-extremity sarcoma resection. [2020]Identifying patients who may be at high risk for wound complications postsarcoma resection and reconstruction is essential for improving functional outcomes and quality of life. Currently, the effect of timing on sarcoma reconstruction has been poorly investigated. The purpose of this study was to compare outcomes of delayed and immediate reconstruction in the setting of sarcoma resection requiring flap reconstruction in the lower extremity.
Experiences of return to work after treatment for extremital soft tissue or bone sarcoma: Between distraction and leaving the disease behind. [2020]We aimed to explore the return to work (RTW) experience of individuals in remission from extremital sarcoma.
GHOST Protocol: Greatest Healing Opportunity for Soft Tissue, a Treatment Paradigm for Complex Sarcoma Reconstruction. [2022]Modern sarcoma treatment has created new challenges for plastic surgeons. This study was designed to review the recent experience and practice patterns following complex sarcoma resection at a large sarcoma center. All cases from October 2013 to October 2014 involving rare nonepithelial tumors, a multidisciplinary surgical team, radiation and/or chemotherapy treatments, and plastic surgical reconstruction were included in the analysis. In addition to evaluating clinical outcomes, cases were reviewed to identify factors associated with excellent or poor patient care. Review of these cases formed the basis of the greatest healing opportunity for soft tissue (GHOST) protocol. Our patient population included seven males (64%) and four females (36%). All except one patient was exposed to radiotherapy, chemotherapy, or some combination. Diverse procedures were used for reconstruction. Early complications occurred in two patients (18%), and late complications in four patients (36%). Sarcoma resection was found to be highly morbid in our series. Patients with poor preoperative nutritional status were more likely to experience complications postoperatively. The decision to stage a reconstruction was complex and influenced by several factors. Multimodal sarcoma treatments may involve highly morbid procedures and create complex wounds. The GHOST protocol is a useful reference for plastic surgeons.
Enhanced recovery after surgery pathway in patients with soft tissue sarcoma. [2021]Patients undergoing surgery for soft tissue sarcoma have high morbidity rates, particularly after preoperative radiation therapy (RT). An enhanced recovery after surgery (ERAS) programme may improve perioperative outcomes in abdominal surgery. This study reported outcomes of an ERAS programme tailored to patients with soft tissue sarcoma.
Neoadjuvant chemoradiation (modified Eilber protocol) versus adjuvant radiotherapy in the treatment of extremity soft tissue sarcoma. [2017]Local control for extremity soft tissue sarcomas (STS) requires surgery combined with radiotherapy, usually given pre-operatively or post-operatively. The modified Eilber protocol, a neoadjuvant chemoradiation regimen, has been reported with excellent local control rates. This retrospective single-centre study compared outcomes for patients treated with the modified Eilber protocol with those treated with standard adjuvant radiotherapy.
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]Despite the low incidence of sarcomas, the Soft Tissue and Bone Sarcoma Group has established itself as one of the more active cooperative groups of the European Organization for Research and Treatment of Cancer. Performing over a 10 yr period three phase III protocols (total entry 750 patients), three randomized phase II studies (464 patients), a pilot combination study (185 patients), and 12 phase II studies (406 patients). The new randomized phase III protocol for advanced soft-tissue sarcoma will provide an interesting test of the validity of the current membership policy, which has not discouraged the participation of enthusiastic new members. For extremity sarcomas, improved surgical techniques have increased the number of patients retaining functional limbs but have maintained excellent rates of local control. However, systemic metastasis remains a significant problem and presents a challenge for future adjuvant studies.
Does intensity of surveillance affect survival after surgery for sarcomas? Results of a randomized noninferiority trial. [2022]Whether current postoperative surveillance regimes result in improved overall survival (OS) of patients with extremity sarcomas is unknown.
Role of expert centres in the management of sarcomas--a UK perspective. [2022]Sarcomas are a rare group of tumours with many differing behaviours and histologies. The generally poor outcomes for patients with sarcoma have not significantly improved over recent years in the United Kingdom. The reasons for this are multi-factorial but delayed diagnosis plays an important role. Developing patient pathways and clinical guidelines is critical to improving patient outcomes as well as raising awareness of sarcoma in primary and secondary care. Expert centres play a key role in diagnosis and the complex multimodality treatment of sarcoma; furthermore centralising of care is critical to improving outcomes as this where multidisciplinary expertise is concentrated. In this review we explore the current role of the expert centre from a United Kingdom (UK) perspective and compare and contrast this with practice elsewhere.