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Active, Not Recruiting

NCT Number: NCT02456389

Perioperative Risk Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > or = 18 years at diagnosis.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3.
  • Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).
  • 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
  • Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days after First Registration.
  • Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
  • Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments.

Exclusion criteria

  • Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature.
  • 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
  • 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.

Treatment and study plan

Preoperative risk stratification

Other

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

Postoperative risk stratification

Other

Postoperative risk-prediction tool based on intraoperative variables

Risk-based, escalating levels of care

Other

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

Risk-based, escalating levels of monitoring

Other

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

Risk-based, escalating levels of co-management

Other

Varying use of Hospitalist co-management

Standard Postoperative Care

Other

Routine postoperative care, as medically indicated

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of death

    Time frame: 30-day postoperative period

  2. Rate of serious complication (as defined by ACS NSQIP)

    Time frame: 30-day postoperative period

  3. Rate of serious/grade 3-4 adverse event (as defined by CTCAE)

    Time frame: 30-day postoperative period

  4. Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)

    Time frame: 30-day postoperative period

  5. Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)

    Time frame: 30-day postoperative period

  6. Rate of cardiac complications

    Time frame: 30-day postoperative period

  7. Rate of pulmonary complications

    Time frame: 30-day postoperative period

  8. Rate of renal complications

    Time frame: 30-day postoperative period

  9. Rate of wound complications

    Time frame: 30-day postoperative period

  10. Rate of infectious complications

    Time frame: 30-day postoperative period

  11. Rate of return to the operating room

    Time frame: 30-day postoperative period

  12. Rate of primary intensive care unit admission

    Time frame: From date of index surgery to date of hospital discharge, up to 3 months

  13. Rate of secondary intensive care unit admission

    Time frame: From date of index surgery to date of hospital discharge, up to 3 months

  14. Length of stay

    Time frame: From date of index surgery to date of hospital discharge, up to 3 months

  15. Total hospital charges

    Time frame: From date of index surgery to date of hospital discharge, up to 3 months

  16. Rate of discharge to home

    Time frame: From date of index surgery to date of hospital discharge, up to 3 months

  17. Rate of hospital readmission

    Time frame: 30-day postoperative period

  18. Health-related quality of life

    Time frame: Postoperative (at 30 days)

  19. Receipt of anti-neoplastic therapy

    Time frame: 30-day postoperative period

  20. 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

Other outcomes

  1. Rate of unplanned return to the operating room

    Time frame: 30-day postoperative period

  2. Rate of unplanned hospital readmission

    Time frame: 30-day postoperative period

  3. Rate of hospital readmission

    Time frame: 60-day postoperative period

  4. Rate of hospital readmission

    Time frame: 90-day postoperative period

  5. Health-related quality of life

    Time frame: Postoperative (at 60 days)

  6. Health-related quality of life

    Time frame: Postoperative (at 90 days)

  7. Receipt of anti-neoplastic therapy

    Time frame: 60-day postoperative period

  8. Receipt of anti-neoplastic therapy

    Time frame: 90-day postoperative period

  9. 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

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Official study title

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

Acronym: PRS

Important dates

Study start
2014
Primary completion
2020
Study completion
2025
First posted
May 28, 2015
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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