Perioperative Risk Study

Not Applicable

Active, not recruiting

• Conditions: Primary Neoplasm; Surgery; Tumors; Secondary Neoplasm
• Interventions: Other: Standard postoperative care; Other: Preoperative risk stratification; Other: Postoperative risk stratification; Other: Risk-based, escalating levels of care; Other: Risk-based, escalating levels of monitoring; Other: Risk-based, escalating levels of co-management

• Registration Number: NCT02456389
• Lead Sponsor: Fox Chase Cancer Center

Brief 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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-28
• Primary Completion: 2020-06-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1456

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard perioperative management	Standard postoperative care	Standard postoperative care
Risk-based, perioperative management	Preoperative risk stratification	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
Risk-based, perioperative management	Postoperative risk stratification	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
Risk-based, perioperative management	Risk-based, escalating levels of monitoring	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
Risk-based, perioperative management	Risk-based, escalating levels of care	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
Risk-based, perioperative management	Risk-based, escalating levels of co-management	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

Primary Outcome Measures

Name	Time	Method
Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])	30-day postoperative period

Secondary Outcome Measures

Name	Time	Method
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 renal complications	30-day postoperative period
Rate of infectious 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)

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States