NCT00144924终止不适用
Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Time to full feeds
研究概览
简要总结
Comparison of open and laparoscopic pyloromyotomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 0 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of infantile hypertrophic pyloric stenosis
排除标准
- •Presence of co-existing congenital or chromosomal abnormality
- •The need to perform any additional procedure at the time of pylotomyotomy
- •Failure to receive informed consent
结局指标
主要结局
Time to full feeds
时间窗: 6 weeks
Episodes of post-operative vomiting
时间窗: 24h
Post operative length of stay
时间窗: 6 weeks
次要结局
- Operating time(24h)
- Post-operative complications(6 weeks)
- Peri-operative complications(24h)
- Post-operative pain and analgesia requirements(6 weeks)
- Anaesthetic time(24h)
- Total in-hospital costs(6 months)
- Cosmetic outcome(6 weeks)
研究者
研究点 (1)
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