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ACTIVE NOT RECRUITING
NCT02456389
NA

Perioperative Risk Study

Sponsor: Fox Chase Cancer Center

View on ClinicalTrials.gov

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

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

OTHER

Standard postoperative care

Routine postoperative care, as medically indicated

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States