Clinical trial NCT02456389: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tumors
Primary Neoplasm
Secondary Neoplasm
Surgery
Keywords: Probable cancer
Proven cancer
Elective cancer surgery
Postoperative death
Postoperative complications
Healthcare utilization
Quality of life
Adjuvant therapy
Disease-free survival
Overall survival
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 1456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])
timeFrame: 30-day postoperative period
Secondary outcomes:
measure: Rate of death
timeFrame: 30-day postoperative period
measure: Rate of serious complication (as defined by ACS NSQIP)
timeFrame: 30-day postoperative period
measure: Rate of serious/grade 3-4 adverse event (as defined by CTCAE)
timeFrame: 30-day postoperative period
measure: Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)
timeFrame: 30-day postoperative period
measure: Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)
timeFrame: 30-day postoperative period
measure: Rate of cardiac complications
timeFrame: 30-day postoperative period
measure: Rate of pulmonary complications
timeFrame: 30-day postoperative period
measure: Rate of renal complications
timeFrame: 30-day postoperative period
measure: Rate of wound complications
timeFrame: 30-day postoperative period
measure: Rate of infectious complications
timeFrame: 30-day postoperative period
measure: Rate of return to the operating room
timeFrame: 30-day postoperative period
measure: Rate of primary intensive care unit admission
timeFrame: From date of index surgery to date of hospital discharge, up to 3 months
measure: Rate of secondary intensive care unit admission
timeFrame: From date of index surgery to date of hospital discharge, up to 3 months
measure: Length of stay
timeFrame: From date of index surgery to date of hospital discharge, up to 3 months
measure: Total hospital charges
timeFrame: From date of index surgery to date of hospital discharge, up to 3 months
measure: Rate of discharge to home
timeFrame: From date of index surgery to date of hospital discharge, up to 3 months
measure: Rate of hospital readmission
timeFrame: 30-day postoperative period
measure: Health-related quality of life
timeFrame: Postoperative (at 30 days)
measure: Receipt of anti-neoplastic therapy
timeFrame: 30-day postoperative period
measure: Overall survival
timeFrame: 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:
measure: Rate of unplanned return to the operating room
timeFrame: 30-day postoperative period
measure: Rate of unplanned hospital readmission
timeFrame: 30-day postoperative period
measure: Rate of hospital readmission
timeFrame: 60-day postoperative period
measure: Rate of hospital readmission
timeFrame: 90-day postoperative period
measure: Health-related quality of life
timeFrame: Postoperative (at 60 days)
measure: Health-related quality of life
timeFrame: Postoperative (at 90 days)
measure: Receipt of anti-neoplastic therapy
timeFrame: 60-day postoperative period
measure: Receipt of anti-neoplastic therapy
timeFrame: 90-day postoperative period
measure: Disease-free survival
timeFrame: 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
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Nestor F Esnaola, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References: