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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02456389
Other study ID # SURG-073
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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