Tumors, Primary Neoplasm, Secondary Neoplasm, Surgery
Conditions
Keywords
Probable cancer, Proven cancer, Elective cancer surgery, Postoperative death, Postoperative complications, Healthcare utilization, Quality of life, Adjuvant therapy, Disease-free survival, Overall survival
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.
Interventions
Routine postoperative care, as medically indicated
OTHERPreoperative risk stratification
Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure
OTHERPostoperative risk stratification
Postoperative risk-prediction tool based on intraoperative variables
OTHERRisk-based, escalating levels of care
Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU
OTHERRisk-based, escalating levels of monitoring
Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system
OTHERRisk-based, escalating levels of co-management
Varying use of Hospitalist co-management
Sponsors
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> or = 18 years at diagnosis. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3. 3. Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage). 4. 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 5. Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days after First Registration. 6. Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document 7. Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments.
Exclusion criteria
1. Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature. 2. 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 3. 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Receipt of anti-neoplastic therapy | 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 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 |
| 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 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 |
| Health-related quality of life | Postoperative (at 30 days) |
| 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 |
| Rate of death | 30-day postoperative period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of unplanned hospital readmission | 30-day postoperative period | — |
| Rate of hospital readmission | 60-day postoperative period | — |
| Health-related quality of life | Postoperative (at 60 days) | — |
| Receipt of anti-neoplastic therapy | 60-day postoperative period | — |
| Disease-free survival | 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 |
| Rate of unplanned return to the operating room | 30-day postoperative period | — |
Countries
United States
Outcome results
None listed