Risk-based Monitoring and Care for Surgery

(PRS Trial)

Overseen By John W Lee, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Must not be taking: Systemic chemotherapy

Disqualifiers: Benign tumors, Recent radiation, others

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

Compensation: Varies

Number of Visits: Unknown

1456 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this trial is to determine if perioperative risk stratification and risk-based, protocol-driven management leads to a reduction in the rate of death or serious complications compared to standard perioperative management in patients undergoing elective major cancer surgery.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using systemic chemotherapy or radiation therapy, you must stop at least 14 days before joining the trial.

What data supports the effectiveness of the treatment Risk-based Monitoring and Care for Surgery?

Research shows that risk stratification (sorting patients based on their risk levels) can help improve surgical outcomes by tailoring care to individual needs. This approach has been shown to reduce complications and improve survival rates by ensuring that patients receive the right level of care based on their specific risk factors. ^{1 2 3 4 5}

Is risk-based monitoring and care for surgery generally safe for humans?

Risk-based monitoring and care for surgery, which involves assessing and managing potential risks before and after surgery, is generally considered safe. It helps in identifying patients who might need more attention, thus reducing complications and improving overall care quality. ^{3 5 6 7 8}

How does the treatment 'Risk-based Monitoring and Care for Surgery' differ from other treatments for surgical risk management?

This treatment is unique because it uses a risk-based approach to tailor the level of care, co-management, and monitoring for each patient based on their preoperative risk assessment. This personalized strategy aims to improve surgical outcomes by adjusting the care plan according to the patient's specific risk factors, unlike standard treatments that may not be as individualized. ^{6 9 10 11 12}

Research Team

Nestor F Esnaola, MD, MPH, MBA

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

This trial is for adults with confirmed or suspected malignant tumors, including various types of cancer surgeries (like lung resection, hysterectomy), who can visit Fox Chase Cancer Center for all study assessments. They should be fit enough for surgery (ECOG status 0-3) and not have had recent chemotherapy or radiation therapy.

Inclusion Criteria

Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments

Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage)

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3

Exclusion Criteria

Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results

Use of systemic chemotherapy and/or radiation therapy less than 14 days prior to First Registration. Palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics

You have been diagnosed with a non-cancerous tumor or a tumor that is not clearly defined as cancerous or non-cancerous.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Risk Stratification

Participants undergo preoperative risk stratification to identify those at increased risk of postoperative complications

1-2 weeks

Surgery and Immediate Postoperative Care

Participants undergo elective major cancer surgery followed by immediate postoperative care

1 week

Postoperative Risk-based Management

Participants receive risk-based, protocol-driven management including escalating levels of care, monitoring, and co-management

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Treatment Details

Interventions

• Postoperative risk stratification
• Preoperative risk stratification
• Risk-based, escalating levels of care
• Risk-based, escalating levels of co-management
• Risk-based, escalating levels of monitoring
• Standard postoperative care

Trial Overview The study tests if a personalized risk assessment before and after surgery, followed by tailored levels of care and monitoring, can reduce death or serious complications compared to standard care in patients having major cancer surgery.

Participant Groups

Group I: Risk-based, perioperative management Experimental Treatment 5 Interventions

Preoperative risk stratification Postoperative risk stratification Risk-based, escalating levels of care Risk-based, escalating levels of monitoring Risk-based, escalating levels of co-management

Group II: Standard perioperative management Active Control 1 Intervention

Standard postoperative care

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Findings from Research

In a study of 3,807 surgical patients over 22 months, 30.9% experienced adverse events, with 6.9% of admissions linked to errors, highlighting a significant incidence of complications in surgical care.

Implementing continuous data collection on adverse events led to a reduction in error rates from 11.1% to 4.5%, demonstrating that systematic monitoring can enhance patient safety and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. Rebasa, P., Mora, L., Luna, A., et al.[2022]

References

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

Quantifying risk and assessing outcome in cardiac surgery. [2019]

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

Perioperative cardiac biomarkers: the utility and timing. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

IPOscore: An interactive web-based platform for postoperative surgical complications analysis and prediction in the oncology domain. [2022]

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

Is the SORT score reliable in predicting postoperative 30-day mortality after a nonemergency surgery in Saudi population? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Perioperative risk. [2019]

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

Modeling perioperative risk: can numbers speak louder than words? [2019]

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

Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Risk assessment and risk stratification for perioperative complications and mitigation: Where should the focus be? How are we doing? [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Risk assessment]. [2019]

10. Australia pubmed.ncbi.nlm.nih.gov

Systematic review of perioperative mortality risk prediction models for adults undergoing inpatient non-cardiac surgery. [2021]

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

Cardiac risk assessment before non-cardiac surgery. [2022]

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

Risk stratification models for cardiac surgery. [2008]