NCT02456389

Perioperative Risk Study

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,456 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tumors
• Primary Neoplasm
• Secondary Neoplasm
• Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2020-06-19
• Completion: 2025-06-01
• First posted: 2015-05-28
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States