Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)
研究概览
简要总结
Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. The relative benefits between Nissen and other fundoplication techniques in children are still uncertain.
The aim of our study was to compare the long-term outcomes following laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Month 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)
排除标准
- •Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study
结局指标
主要结局
Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)
Early death following surgery directly related to the fundoplication technique
次要结局
- The resumption of symptoms bad enough to necessitate the re-introduction of anti-reflux medication (but not sufficiently bad to require revisional surgery) i.e. "intention to treat"
- Post-operative complications (e.g. post-operative dysphagia)