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Risk-based Monitoring and Care for Surgery (PRS Trial)

N/A
Waitlist Available
Led By Nestor F Esnaola, MD, MPH, MBA
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of index surgery to date of death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months
Awards & highlights

PRS Trial Summary

This trial is testing if a different way of managing patients during and after surgery for cancer reduces the rate of death or serious complications.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on monitoring strategies rather than medications, side effects are not the main concern. However, there may be risks associated with increased interventions based on risk stratification.

PRS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of index surgery to date of death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of index surgery to date of death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])
Secondary outcome measures
Length of stay
Overall survival
Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)
+14 more
Other outcome measures
Disease-free survival
Health-related quality of life
Rate of hospital readmission
+3 more

PRS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Risk-based, perioperative managementExperimental Treatment5 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 managementActive Control1 Intervention
Standard postoperative care

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
36,053 Total Patients Enrolled
1 Trials studying Surgery
880 Patients Enrolled for Surgery
Nestor F Esnaola, MD, MPH, MBAPrincipal InvestigatorFox Chase Cancer Center

Media Library

Preoperative risk stratification Clinical Trial Eligibility Overview. Trial Name: NCT02456389 — N/A
Surgery Research Study Groups: Standard perioperative management, Risk-based, perioperative management
Surgery Clinical Trial 2023: Preoperative risk stratification Highlights & Side Effects. Trial Name: NCT02456389 — N/A
Preoperative risk stratification 2023 Treatment Timeline for Medical Study. Trial Name: NCT02456389 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Perioperative Risk Study
2014. "Perioperative Risk Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02456389.
~136 spots leftby Apr 2025
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