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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Rate of renal complications(30-day postoperative period)
• Rate of infectious complications(30-day postoperative period)
• Rate of return to the operating room(30-day postoperative period)
• Rate of primary intensive care unit admission(From date of index surgery to date of hospital discharge, up to 3 months)
• Overall survival(From date of index surgery to date of death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months)
• Rate of death(30-day postoperative period)
• Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)(30-day postoperative period)
• Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)(30-day postoperative period)
• Rate of pulmonary complications(30-day postoperative period)
• Rate of secondary intensive care unit admission(From date of index surgery to date of hospital discharge, up to 3 months)
• Length of stay(From date of index surgery to date of hospital discharge, up to 3 months)
• Rate of serious/grade 3-4 adverse event (as defined by CTCAE)(30-day postoperative period)
• Rate of serious complication (as defined by ACS NSQIP)(30-day postoperative period)
• Rate of cardiac complications(30-day postoperative period)
• Rate of wound complications(30-day postoperative period)
• Total hospital charges(From date of index surgery to date of hospital discharge, up to 3 months)
• Rate of discharge to home(From date of index surgery to date of hospital discharge, up to 3 months)
• Rate of hospital readmission(30-day postoperative period)
• Receipt of anti-neoplastic therapy(30-day postoperative period)
• Health-related quality of life(Postoperative (at 30 days))