Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 893
- 试验地点
- 1
- 主要终点
- length of stay
研究概览
简要总结
This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.
详细描述
The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. The major outcome is whether it can reduce the length of stay in hospital (LOS), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.
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
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages<14; no gender limitation;
- •Alvarado scores ≥7;
- •preoperative radiography examination indicated complicated appendicitis;
- •Patients or their legal representatives have signed "informed consent"
排除标准
- •complicated life-threatening disease;
- •perioperative exploration not appendicitis;
- •Recently participated in other clinical trials within 3 months;
- •Researchers found not fit to participate in this trial for any condition
结局指标
主要结局
length of stay
时间窗: through study completion, an average of 7 days
less hospital length of stay
次要结局
- first time for postoperative feeding(up to 72 hours)
- rate of re-operation(1 months)
- first time for postoperative exercising(1-2 days)
- rate of postoperative complication(1 months)
- rate of re-admission(1 months)
研究者
Feng Jiexiong
professor
Tongji Hospital