Perioperative Risk Study (PRS)

A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Tumors; Primary Neoplasm; Secondary Neoplasm
• Intervention / Treatment: Other: Standard postoperative care; Other: Preoperative risk stratification; Other: Postoperative risk stratification; Other: Risk-based, escalating levels of care; Other: Risk-based, escalating levels of monitoring; Other: Risk-based, escalating levels of co-management

Detailed Description

Major cancer surgery is associated with significant rates of postoperative mortality and major morbidity. Postoperative morbidity adversely impacts healthcare utilization, healthcare costs, rates of discharge to home, quality of life, rates of receipt of postoperative anti-neoplastic therapy, disease-free survival, and overall survival. The investigators hypothesize that perioperative risk stratification and risk-based, protocol-driven management (compared to standard perioperative management) will lead to a reduction in 30-day post-operative mortality or major morbidity in patients undergoing major cancer surgery. This is based on our theory that preoperative/postoperative use of newly developed, perioperative risk-prediction tools will help identify patients at increased risk of postoperative death or serious complications that might benefit from risk-based, protocol-driven perioperative management, including escalating levels of care, escalating levels of monitoring, and escalating levels of hospitalist co-management. The set of assessments and interventions in the proposed study are conceptually similar to other "bundled" interventions which have recently been recently tested and demonstrated to reduce perioperative mortality and morbidity.

• Study Type: Interventional
• Enrollment (Estimated): 1456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA:

1. Age > or = 18 years at diagnosis.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3.
3. Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).

4. Scheduled for curative or palliative major cancer surgery, including:

   • Glossectomy
   • Pharyngectomy
   • Laryngectomy
   • Neck dissection
   • Esophagectomy
   • Lung resection
   • Gastrectomy
   • Pancreatectomy
   • Hepatectomy
   • Colectomy
   • Proctectomy
   • Hysterectomy/Myomectomy
   • Gynecologic reconstruction
   • Prostatectomy
   • Nephrectomy
   • Cystectomy
   • Breast reconstruction
   • Flap reconstruction
5. Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days after First Registration.
6. Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
7. Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments.

EXCLUSION CRITERIA:

1. Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature.
2. Use of systemic chemotherapy and/or radiation therapy < 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
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard perioperative management; Standard postoperative care	Other: Standard postoperative care; Routine postoperative care, as medically indicated
Experimental: Risk-based, perioperative management; 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	Other: Preoperative risk stratification; Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure; Other: Postoperative risk stratification; Postoperative risk-prediction tool based on intraoperative variables; Other: Risk-based, escalating levels of care; Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU; Other: Risk-based, escalating levels of monitoring; Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system; Other: Risk-based, escalating levels of co-management; Varying use of Hospitalist co-management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])	30-day postoperative period

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of death	30-day postoperative period
Rate of serious complication (as defined by ACS NSQIP)	30-day postoperative period
Rate of serious/grade 3-4 adverse event (as defined by CTCAE)	30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)	30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)	30-day postoperative period
Rate of cardiac complications	30-day postoperative period
Rate of pulmonary complications	30-day postoperative period
Rate of renal complications	30-day postoperative period
Rate of wound complications	30-day postoperative period
Rate of infectious complications	30-day postoperative period
Rate of return to the operating room	30-day postoperative period
Rate of primary intensive care unit admission	From date of index surgery to date of hospital discharge, up to 3 months
Rate of secondary intensive care unit admission	From date of index surgery to date of hospital discharge, up to 3 months
Length of stay	From date of index surgery to date of hospital discharge, up to 3 months
Total hospital charges	From date of index surgery to date of hospital discharge, up to 3 months
Rate of discharge to home	From date of index surgery to date of hospital discharge, up to 3 months
Rate of hospital readmission	30-day postoperative period
Health-related quality of life	Postoperative (at 30 days)
Receipt of anti-neoplastic therapy	30-day postoperative period
Overall survival	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of unplanned return to the operating room		30-day postoperative period
Rate of unplanned hospital readmission		30-day postoperative period
Rate of hospital readmission		60-day postoperative period
Rate of hospital readmission		90-day postoperative period
Health-related quality of life		Postoperative (at 60 days)
Health-related quality of life		Postoperative (at 90 days)
Receipt of anti-neoplastic therapy		60-day postoperative period
Receipt of anti-neoplastic therapy		90-day postoperative period
Disease-free survival	In patients who are deemed to have no clinical evidence of disease after the index surgery	From date of index surgery to date of recurrence, death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Investigators: Principal Investigator: Nestor F Esnaola, MD, MPH, MBA, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): June 19, 2020
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 1, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimated): May 28, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Postoperative complications; Overall survival; Disease-free survival; Adjuvant therapy; Healthcare utilization; Probable cancer; Proven cancer; Elective cancer surgery; Postoperative death
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SURG-073