Philadelphia, Pennsylvania 19111


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

SURG-073


NCT ID:

NCT02456389


Secondary ID:


Study Acronym:

PRS


Brief Title:

Perioperative Risk Study


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fox Chase Cancer Center


Oversight Authority:

  • United States: Data and Safety Monitoring Board
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1456


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Nestor F Esnaola, MD, MPH, MBA
Principal Investigator
Fox Chase Cancer Center
Primary Contact:John W Lee, CCRP
215-728-2586
John.W.Lee@fccc.edu

Study Dates

Start Date:August 2014
Completion Date:October 2019
Completion Type:Anticipated
Primary Completion Date:October 2019
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 26, 2019
First Received Date:May 1, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of death
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of serious complication (as defined by ACS NSQIP)
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of serious/grade 3-4 adverse event (as defined by CTCAE)
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of cardiac complications
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of pulmonary complications
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of renal complications
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of wound complications
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of infectious complications
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of return to the operating room
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of primary intensive care unit admission
Time Frame:From date of index surgery to date of hospital discharge, up to 3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of secondary intensive care unit admission
Time Frame:From date of index surgery to date of hospital discharge, up to 3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Length of stay
Time Frame:From date of index surgery to date of hospital discharge, up to 3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Total hospital charges
Time Frame:From date of index surgery to date of hospital discharge, up to 3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of discharge to home
Time Frame:From date of index surgery to date of hospital discharge, up to 3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Rate of hospital readmission
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Health-related quality of life
Time Frame:Postoperative (at 30 days)
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Receipt of anti-neoplastic therapy
Time Frame:30-day postoperative period
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Overall survival
Time Frame:From date of index surgery to date of death, loss to follow-up, or end of study, whichever comes fir
Safety Issues:False

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:Risk-based, perioperative management
Description: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
Study Arm Type:Active Comparator
Arm Name:Standard perioperative management
Description:Standard postoperative care

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fox Chase Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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