Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
NCT Number: NCT02456389
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19111, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure
Postoperative risk-prediction tool based on intraoperative variables
Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU
Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system
Varying use of Hospitalist co-management
Routine postoperative care, as medically indicated
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Time frame: From date of index surgery to date of hospital discharge, up to 3 months
Time frame: 30-day postoperative period
Time frame: Postoperative (at 30 days)
Time frame: 30-day postoperative period
Time frame: 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
Time frame: 30-day postoperative period
Time frame: 30-day postoperative period
Time frame: 60-day postoperative period
Time frame: 90-day postoperative period
Time frame: Postoperative (at 60 days)
Time frame: Postoperative (at 90 days)
Time frame: 60-day postoperative period
Time frame: 90-day postoperative period
Time frame: From date of index surgery to date of recurrence, death, loss to follow-up, or end of study, whichever comes first, assessed up to 60 months
In patients who are deemed to have no clinical evidence of disease after the index surgery
Fox Chase Cancer Center
Other
A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery
Acronym: PRS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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