Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations, PRS II Study

Inclusion Criteria

• FIRST REGISTRATION-INCLUSION
• Age >= 18 years at diagnosis ( =< 30 days prior to the index surgical procedure)
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 ( =< 30 days prior to the index surgical procedure)
• Patients must have probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage) ( =< 30 days prior to the index surgical procedure)
• Patients undergoing major operations to resect or treat known or suspected malignancies of the head and neck, chest, abdomen, genitourinary tract, or extremities are eligible. Patients undergoing biopsies, outpatient procedures, superficial resections of cutaneous malignancies, or purely palliative operations are not eligible (=< 30 days prior to the index surgical procedure) * These procedures are commonly performed in patients with malignant neoplasms, malignant neuroendocrine tumors, or carcinomas in situ, and are commonly “tracked” by hospitals and cancer centers participating in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) procedure targeted option because they are often associated with higher rates of postoperative morbidity and mortality (compared to other, less complex cancer procedures)
• Patient must be scheduled for elective major cancer surgery at Fox Chase Cancer Center (FCCC) =< 30 days after first registration ( =< 30 days prior to the index surgical procedure) * Elective surgery is defined as: ** Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND ** Surgery is not scheduled as urgent or emergent
• Elective surgery is defined as: * Patient is scheduled to be brought from their home (or normal living environment) to FCCC on the day of the index surgery (or day prior as scheduled admission) AND * Surgery is not scheduled as urgent or emergent ( =< 30 days prior to the index surgical procedure)
• Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document ( =< 30 days prior to the index surgical procedure)
• Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments ( =< 30 days prior to the index surgical procedure)
• SECOND REGISTRATION-INCLUSION
• Elective (curative or palliative) major cancer surgery occurred at the time of the index surgery (patient may have undergone more than one of these procedures) * For the purposes of this study, the procedure that was performed with the highest estimated risk of death or serious complication (DSC) will be denoted at the time of second registration as the “index procedure” performed during the “index surgery”
• Elective surgery =< 30 days after first registration

Exclusion Criteria

• FIRST REGISTRATION-EXCLUSION:
• 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
• SECOND REGISTRATION-EXCLUSION:
• This includes patients whose scheduled procedure was suspended due to unexpected findings, such as carcinomatosis