A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,456
- 试验地点
- 1
- 主要终点
- Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years at diagnosis.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Postoperative risk stratification (Other)
Standard perioperative management
Standard postoperative care
干预措施: Standard postoperative care (Other)
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
干预措施: Preoperative risk stratification (Other)
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
干预措施: Risk-based, escalating levels of care (Other)
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
干预措施: Risk-based, escalating levels of monitoring (Other)
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
干预措施: Risk-based, escalating levels of co-management (Other)
结局指标
主要结局
Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])
时间窗: 30-day postoperative period
次要结局
- Rate of cardiac complications(30-day postoperative period)
- Total hospital charges(From date of index surgery to date of hospital discharge, up to 3 months)
- Rate of return to the operating room(30-day postoperative period)
- Rate of primary intensive care unit admission(From date of index surgery to date of hospital discharge, up to 3 months)
- 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)
- Rate of death(30-day postoperative period)
- Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)(30-day postoperative period)
- Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)(30-day postoperative period)
- Rate of pulmonary complications(30-day postoperative period)
- Rate of renal complications(30-day postoperative period)
- Rate of infectious complications(30-day postoperative period)
- Rate of secondary intensive care unit admission(From date of index surgery to date of hospital discharge, up to 3 months)
- Length of stay(From date of index surgery to date of hospital discharge, up to 3 months)
- Rate of serious complication (as defined by ACS NSQIP)(30-day postoperative period)
- Rate of serious/grade 3-4 adverse event (as defined by CTCAE)(30-day postoperative period)
- Rate of wound complications(30-day postoperative period)
- Rate of hospital readmission(30-day postoperative period)
- Receipt of anti-neoplastic therapy(30-day postoperative period)
- Health-related quality of life(Postoperative (at 30 days))
- Rate of discharge to home(From date of index surgery to date of hospital discharge, up to 3 months)