Perioperative Risk Study

NCT ID: NCT02456389

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2025-06-30

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.

Conditions

Tumors; Primary Neoplasm; Secondary Neoplasm; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard perioperative management

Standard postoperative care

Group Type: ACTIVE_COMPARATOR

Standard postoperative care

Intervention Type: OTHER

Routine postoperative care, as medically indicated

Risk-based, perioperative 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

Group Type: EXPERIMENTAL

Preoperative risk stratification

Intervention Type: OTHER

Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure

Postoperative risk stratification

Intervention Type: OTHER

Postoperative risk-prediction tool based on intraoperative variables

Risk-based, escalating levels of care

Intervention Type: OTHER

Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU

Risk-based, escalating levels of monitoring

Intervention Type: OTHER

Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system

Risk-based, escalating levels of co-management

Intervention Type: OTHER

Varying use of Hospitalist co-management

Interventions

Preoperative risk stratification

Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure

Intervention Type: OTHER

Postoperative risk stratification

Postoperative risk-prediction tool based on intraoperative variables

Intervention Type: OTHER

Risk-based, escalating levels of care

Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU

Intervention Type: OTHER

Risk-based, escalating levels of monitoring

Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system

Intervention Type: OTHER

Risk-based, escalating levels of co-management

Varying use of Hospitalist co-management

Intervention Type: OTHER

Standard postoperative care

Routine postoperative care, as medically indicated

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nestor F Esnaola, MD, MPH, MBA

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

SURG-073

Identifier Type: -

Identifier Source: org_study_id