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临床试验/NCT03055637
NCT03055637Unknown不适用

Evaluation of the Incidence of Palatal Fistula in Furlow Double-opposing Z-plasty vs. Two-flap Palatoplasty for Cleft Palate Repair

Sarah Moustafa Mahmoud Fahmy El-Youtti0 个研究点目标入组 32 人开始时间: 2017年2月19日最近更新:
适应症

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

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

发起方
Sarah Moustafa Mahmoud Fahmy El-Youtti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sarah Moustafa Mahmoud Fahmy El-Youtti

Sarah moustafa mahmoud fahmy Al-Ayoutti

Cairo University

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