Perioperative Risk Study — PRS  

Surgery Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neoplasms
• Primary Neoplasm
• Secondary Neoplasm
• Surgery
• Tumors

• NCT number: NCT02456389
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Completion date: December 2024