Perioperative Risk Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tumors, Primary Neoplasm, Secondary Neoplasm, Surgery

Intervention / Treatment
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* 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
* Other: Standard postoperative care


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Age > or = 18 years at diagnosis. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3. Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage). Scheduled for curative or palliative major cancer surgery, including: Glossectomy Pharyngectomy Laryngectomy Neck dissection Esophagectomy Lung resection Gastrectomy Pancreatectomy Hepatectomy Colectomy Proctectomy Hysterectomy/Myomectomy Gynecologic reconstruction Prostatectomy Nephrectomy Cystectomy Breast reconstruction Flap reconstruction Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days after First Registration. Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments. EXCLUSION CRITERIA: Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature. Use of systemic chemotherapy and/or radiation therapy < 14 days prior to First Registration. Palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard perioperative management<br>Standard postoperative care | Other: Standard postoperative care<br>* Routine postoperative care, as medically indicated<br>|
| Experimental: Risk-based, perioperative management<br>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 | Other: Preoperative risk stratification<br>* Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure<br>Other: Postoperative risk stratification<br>* Postoperative risk-prediction tool based on intraoperative variables<br>Other: Risk-based, escalating levels of care<br>* Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU<br>Other: Risk-based, escalating levels of monitoring<br>* Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system<br>Other: Risk-based, escalating levels of co-management<br>* Varying use of Hospitalist co-management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of death |  | 30-day postoperative period | 
| Rate of serious complication (as defined by ACS NSQIP) |  | 30-day postoperative period | 
| Rate of serious/grade 3-4 adverse event (as defined by CTCAE) |  | 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 cardiac complications |  | 30-day postoperative period | 
| Rate of pulmonary complications |  | 30-day postoperative period | 
| Rate of renal complications |  | 30-day postoperative period | 
| Rate of wound 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 | 
| 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 | 
| 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 | 
| Health-related quality of life |  | Postoperative (at 30 days) | 
| Receipt of anti-neoplastic therapy |  | 30-day postoperative period | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Probable cancer, Proven cancer, Elective cancer surgery, Postoperative death, Postoperative complications, Healthcare utilization, Adjuvant therapy, Disease-free survival, Overall survival