A Prospective Multi-center Randomized Controlled Clinical Trials of Enhanced Recovery After Surgery in Hirschsprung Disease.
试验速览
- 阶段
- 不适用
- 发起方
- Weibing Tang
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- median length of postoperative hospital day
研究概览
简要总结
The study is designed to determine if enhanced recovery after surgery (ERAS) principles could provide benefit for pediatric patients undergoing radical surgery for Hirschsprung's Disease (HD). Half of patients will receive the ERAS program, while the other half will receive the traditional program.
详细描述
Optimized peri-operative care within an enhanced recovery after surgery (ERAS) protocol is designed to reduce morbidity after surgery, resulting in a shorter hospital stay. The present study evaluated this approach in the context of radical surgery for pediatric patients with Hirschsprung's Disease(HD). Patients undergoing radical surgery for HD will be enrolled in a randomized clinical trial comparing ERAS protocol vs a control group that received standard care. The primary outcome is median length of postoperative hospital stay. The second outcomes include postoperative complications rates，gastrointestinal function recovery time，mean cost per patient，readmission rates within postoperative 30 days，and the levels of stress and inflammation marker.
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
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Hirschsprung Disease
排除标准
- •with other disease
- •receive emergency surgery
- •need to do the ostomy
- •full colonic Hirschsprung Disease
结局指标
主要结局
median length of postoperative hospital day
时间窗: 30days
次要结局
- postoperative complications rates(within 30 days)
- gastrointestinal functional recovery time(within 30 days)
- mean cost per patient(within 30 days)
- the readmission rates(within 30 days)
- the level of stress and inflammation marker(within 30 days)
研究者
Weibing Tang
Dr. Weibing Tang
Nanjing Children's Hospital