Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- episodes of postoperative vomiting
研究概览
简要总结
Infantile hypertrophic pyloric stenosis (IHPS) is the most common condition for surgical treatment in infant. Traditionally, laparoscopic or open pyloromyotomy are the standard treatments. However, because of severe dehydration, electrolyte disturbance, and malnutrition, these patients have lower tolerance about surgery and recover more slowly than usual. We are going to study the per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), which showed promising results for adult gastroparesis, for a novel application of treating IHPS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of pyloric stenosis with or without sonographic confirmation.
排除标准
- •Comorbid conditions that could affect postoperative recovery.
- •Needed an additional procedure during the same anaesthetic.
结局指标
主要结局
episodes of postoperative vomiting
时间窗: 6 months after surgery
Primary outcomes included episodes of postoperative vomiting in times.
major complication
时间窗: 6 months after surgery
Primary outcomes included major complication in times (based on lexicon and Clavien-Dindo classification, eg, vital-sign instability, ICU stay, hospital readmission, conversion to laparoscopic or open pyloromyotomy, invasive postoperative procedure, haemorrhage, blood transfusion, or prolonged hospitalization due to functional impairment).
次要结局
- postoperative pain assessment by "Pain assessment for children under four years"(6 months after surgery)
- time to full enteral feed(6 months after surgery)
- need for re-operation(6 months after surgery)
- operating and anaesthetic time(6 months after surgery)
- analgesia requirements(6 months after surgery)
- myotomy length(6 months after surgery)
- other complications(6 months after surgery)
- postoperative length of stay(6 months after surgery)