Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 主要终点
- Incidence of fistula
研究概览
简要总结
Evaluation of the incidence of palatal fistula in Furlow double-opposing z-plasty versus two-flap palatoplasty for cleft palate repair.
详细描述
Up to 6 hours before the scheduled arrival time, formula-fed babies may be given formula. Up to 4 hours before the scheduled arrival time, breastfed babies may nurse. Up to 2 hours before the scheduled arrival time, give only clear liquids. Clear liquids include water, Pedialyte®, Kool-Aid® and juices you can see through, such as apple or white grape juice. In the 2 hours before the scheduled arrival time, give nothing to eat or drink. Induction of general anaesthesia will be administered followed by local anaethesia. Then, Surgical prodecure will be done either following the conventional two flap palatoplasty technique or the Furlow double-opposing z-plasty technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 12 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of Repair from 9 to 12 months.
- •Isolated Cleft Palate
- •Operation time should nearly be the same for all patients
- •Surgical skills done by same surgeon
排除标准
- •Patients with hypoplasia of palatal tissue.
- •Patients with associated anomalies.
- •Patients with associated syndromes.
- •Other types of cleft palate.
结局指标
主要结局
Incidence of fistula
时间窗: 6 months
次要结局
未报告次要终点
研究者
Sarah Moustafa Mahmoud Fahmy El-Youtti
Sarah moustafa mahmoud fahmy Al-Ayoutti
Cairo University
