Perioperative Risk Study (PRS)

April 3, 2025 updated by: Fox Chase Cancer Center

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard perioperative management
Standard postoperative care
Other: Standard postoperative care
Routine postoperative care, as medically indicated
Experimental: 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
Other: Preoperative risk stratification
Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure
Other: Postoperative risk stratification
Postoperative risk-prediction tool based on intraoperative variables
Other: Risk-based, escalating levels of care
Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU
Other: Risk-based, escalating levels of monitoring
Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system
Other: Risk-based, escalating levels of co-management
Varying use of Hospitalist co-management

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
30-day postoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of death
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of serious complication (as defined by ACS NSQIP)
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of serious/grade 3-4 adverse event (as defined by CTCAE)
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of cardiac complications
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of pulmonary complications
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of renal complications
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of wound complications
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of infectious complications
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of return to the operating room
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of primary intensive care unit admission
Time Frame: From date of index surgery to date of hospital discharge, up to 3 months
From date of index surgery to date of hospital discharge, up to 3 months
Rate of secondary intensive care unit admission
Time Frame: From date of index surgery to date of hospital discharge, up to 3 months
From date of index surgery to date of hospital discharge, up to 3 months
Length of stay
Time Frame: From date of index surgery to date of hospital discharge, up to 3 months
From date of index surgery to date of hospital discharge, up to 3 months
Total hospital charges
Time Frame: From date of index surgery to date of hospital discharge, up to 3 months
From date of index surgery to date of hospital discharge, up to 3 months
Rate of discharge to home
Time Frame: From date of index surgery to date of hospital discharge, up to 3 months
From date of index surgery to date of hospital discharge, up to 3 months
Rate of hospital readmission
Time Frame: 30-day postoperative period
30-day postoperative period
Health-related quality of life
Time Frame: Postoperative (at 30 days)
Postoperative (at 30 days)
Receipt of anti-neoplastic therapy
Time Frame: 30-day postoperative period
30-day postoperative period
Overall survival
Time Frame: 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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of unplanned return to the operating room
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of unplanned hospital readmission
Time Frame: 30-day postoperative period
30-day postoperative period
Rate of hospital readmission
Time Frame: 60-day postoperative period
60-day postoperative period
Rate of hospital readmission
Time Frame: 90-day postoperative period
90-day postoperative period
Health-related quality of life
Time Frame: Postoperative (at 60 days)
Postoperative (at 60 days)
Health-related quality of life
Time Frame: Postoperative (at 90 days)
Postoperative (at 90 days)
Receipt of anti-neoplastic therapy
Time Frame: 60-day postoperative period
60-day postoperative period
Receipt of anti-neoplastic therapy
Time Frame: 90-day postoperative period
90-day postoperative period
Disease-free survival
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fox Chase Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nestor F Esnaola, MD, MPH, MBA, Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SURG-073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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