Pediatric Oncology Recovery Trial After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Number of 90-day complications by Clavien-Dindo classification
研究概览
简要总结
Pediatric Oncologic Recovery Trial After Surgery (PORTS) trial is an investigator-initiated, multicenter, multidisciplinary prospective case-control study of the implementation of an Enhanced Recovery After Surgery (ERAS) protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer. A pilot phase will determine characteristics of a successful protocol implementation and an exploratory phase plans to examine adherence, objective patient outcomes, and patient-reported outcomes. After completing primary enrollment, this collaborative will continue to enroll patients in the shared data registry and continue to refine the underlying ERAS protocol developed for this project.
详细描述
Two arms:
Historical patients ERAS patients
Number of patients: 288
Primary outcome
· Number of 90-day complications by Clavien-Dindo classification
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing operations at a pediatric hospital setting aged 1 month or older
- •Parents of patients undergoing operations at pediatric hospital settings aged 1 month or older
- •Undergoing urologic reconstruction, ureteral operations, pyeloplasty, intraabdominal on-cologic resections, urachal remnant excision, bariatric operations, pectus surgery, ap-pendicitis, orthopedic or neurosurgical operations and inflammatory bowel disease proce-dures
- •Providers of patients undergoing surgery in pediatric settings
排除标准
- •Less than 1 month in age
研究组 & 干预措施
Historical
Retrospective Review
干预措施: Observational (Other)
ERAS Patients
Prospective Review
干预措施: Observational (Other)
结局指标
主要结局
Number of 90-day complications by Clavien-Dindo classification
时间窗: 90 Days
次要结局
- Recurrence free survival (months)(90 Days)
- Number of Adherence issues to ERAS protocol items with # of items achieved (out of 20)(90 Days)
- Number of Re-admissions within 90 days(90 Days)
- Length of stay(90 Days)
- Mean daily IV morphine equivalents (mg/kg) usage during first 7 days after surgery(90 Days)
- Number of Re-operations within 90 days(90 Days)
- VAS daily pain score during first 7 days after surgery(90 Days)
- Number of visits to the emergency room within 90 day period(90 Days)
- Overall survival (months)(90 Days)