Perioperative Risk Study

Surgery Clinical Trial

— PRS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02456389
• Other study ID #: SURG-073
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1456
• Est. completion date: December 2024
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Primary Neoplasm
• Secondary Neoplasm
• Surgery
• Tumors

Intervention

Other:
• Preoperative risk stratification
Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure
• Postoperative risk stratification
Postoperative risk-prediction tool based on intraoperative variables
• Risk-based, escalating levels of care
Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU
• Risk-based, escalating levels of monitoring
Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system
• Risk-based, escalating levels of co-management
Varying use of Hospitalist co-management
• Standard postoperative care
Routine postoperative care, as medically indicated

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of unplanned return to the operating room		30-day postoperative period
Other	Rate of unplanned hospital readmission		30-day postoperative period
Other	Rate of hospital readmission		60-day postoperative period
Other	Rate of hospital readmission		90-day postoperative period
Other	Health-related quality of life		Postoperative (at 60 days)
Other	Health-related quality of life		Postoperative (at 90 days)
Other	Receipt of anti-neoplastic therapy		60-day postoperative period
Other	Receipt of anti-neoplastic therapy		90-day postoperative period
Other	Disease-free survival	In patients who are deemed to have no clinical evidence of disease after the index surgery	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
Primary	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	Rate of death		30-day postoperative period
Secondary	Rate of serious complication (as defined by ACS NSQIP)		30-day postoperative period
Secondary	Rate of serious/grade 3-4 adverse event (as defined by CTCAE)		30-day postoperative period
Secondary	Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)		30-day postoperative period
Secondary	Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)		30-day postoperative period
Secondary	Rate of cardiac complications		30-day postoperative period
Secondary	Rate of pulmonary complications		30-day postoperative period
Secondary	Rate of renal complications		30-day postoperative period
Secondary	Rate of wound complications		30-day postoperative period
Secondary	Rate of infectious complications		30-day postoperative period
Secondary	Rate of return to the operating room		30-day postoperative period
Secondary	Rate of primary intensive care unit admission		From date of index surgery to date of hospital discharge, up to 3 months
Secondary	Rate of secondary intensive care unit admission		From date of index surgery to date of hospital discharge, up to 3 months
Secondary	Length of stay		From date of index surgery to date of hospital discharge, up to 3 months
Secondary	Total hospital charges		From date of index surgery to date of hospital discharge, up to 3 months
Secondary	Rate of discharge to home		From date of index surgery to date of hospital discharge, up to 3 months
Secondary	Rate of hospital readmission		30-day postoperative period
Secondary	Health-related quality of life		Postoperative (at 30 days)
Secondary	Receipt of anti-neoplastic therapy		30-day postoperative period
Secondary	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