Neoplasms

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Neoplasm Metastasis

Postoperative Complications

Death

Quality of Life

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

Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure

Preoperative risk stratification

Postoperative risk-prediction tool based on intraoperative variables

Postoperative risk stratification

Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU

Risk-based, escalating levels of care

Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system

Risk-based, escalating levels of monitoring

Risk-based, escalating levels of co-management

Routine postoperative care, as medically indicated

Standard postoperative care

Nestor F Esnaola, MD, MPH, MBA

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.

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.

Perioperative Risk Study

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

In patients who are deemed to have no clinical evidence of disease after the index surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Perioperative Risk Study	NCT02456389	Tumors Primary Neoplas... Secondary Neopl... Surgery	Preoperative ri... Postoperative r... Risk-based, esc... Risk-based, esc... Risk-based, esc... Standard postop...	18 Years -	Fox Chase Cancer Center
Perioperative Risk Study	NCT02456389	Tumors Primary Neoplas... Secondary Neopl... Surgery	Preoperative ri... Postoperative r... Risk-based, esc... Risk-based, esc... Risk-based, esc... Standard postop...	18 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for probable cancer