the Effect of the Laparoscopic Management of Gastro Esophageal Reflux on Gastric Emptying in Pediatric Age Group
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- treatment of GERD
研究概览
简要总结
gastric functions especially gastric emptying is still debatable after anti reflux surgery in children. this study aims to predict the best procedure associated with good gastric emptying time and gastric functions following anti reflux procedure when compared two procedures, Nissen fundoplication vs Hil snow fundoplication in multicenter pediatric surgery tertiary hospitals.
详细描述
prospective clinical randomized trial. two groups of patients. group A operatated by Nissen Fundoplication. the other group B operated by Hil Snow procedure. gastric empyting time and post fundoplication symptoms are collected and correlated to both groups patients.
these results will be evaluated by gastric emptying studies and upper GI endoscopy together with symptoms as dysphagia, satiety and discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 24 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all children with GERD above the age of 24 months until 18 years
排除标准
- •previous antireflux surgery
- •previous exploration
- •Esophageal atresia congenital diaphragmatic hernia omphalocele major
结局指标
主要结局
treatment of GERD
时间窗: 6 months post operative till two years post operative
gastric emptying time
时间窗: 6 months post operative till two years post operative
post fundoplication symptoms as dysphagia or air bloating syndrome
时间窗: 6 months post operative till two years post operative
次要结局
未报告次要终点
研究者
Mohammad Gharieb Mohammad Khirallah
professor of pediatric surgery
Tanta University