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Perioperative Risk Study
Sponsor: Fox Chase Cancer Center
Summary
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.
Official title: A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1456
Start Date
2014-08
Completion Date
2025-06
Last Updated
2025-04-04
Healthy Volunteers
No
Interventions
Preoperative risk stratification
Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure
Postoperative risk stratification
Postoperative risk-prediction tool based on intraoperative variables
Risk-based, escalating levels of care
Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU
Risk-based, escalating levels of monitoring
Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system
Risk-based, escalating levels of co-management
Varying use of Hospitalist co-management
Standard postoperative care
Routine postoperative care, as medically indicated
Locations (1)
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States