跳至主要内容
临床试验/NCT04346173
NCT04346173已完成不适用

Palatal Lengthening Using Buccinator Myomucosal Flaps with Furlow Z-plasty Technique for Primary Cleft Palate Repair (A Clinical Study)

Mahmoud Akram1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
palatal lengthening

研究概览

简要总结

: Cleft palate is a congenital deformity caused by abnormal facial development during intra-uterine life. Worldwide, the prevalence of cleft lip/palate is about 1:1000 live births.

The levator vela palatini muscles are malpositioned sagittally, running postero-anteriorly and inserted onto the posterior edge of the hard palate in cleft palate patients . This configuration prevents the muscle from exerting its upward, backward, and lateral pull.

Various modalities have been described with major refinements over the past 30 years. Gradually, cleft surgeons began to appreciate the importance of dissection and retro-positioning of the levator muscle on improving speech outcomes.

Furlow was the first to describe the palatoplasty technique, in which the levator muscle is dissected and freely released from its abnormal position and retro-positioned in a Z-plasty lengthening technique without dissection on the hard palate. However , among the problems that have been raised concerning the Furlow palatoplasty is the limitation of the procedure in wide clefts. Furthermore, the possibility of higher fistula rate associated with the technique.

These considerations have led to modified palatal lengthening by buccinator myomucosal flaps which is this study working on.

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
9 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients in the age frame between 9 months and 18 months.
  • Cleft palate alone or cleft lip and palate patients.
  • Patients who have not done any previous palatal repair
  • Haemoglobin level above 10 grams.
  • Weight above 10 pounds.

排除标准

  • Syndromic patients.
  • Medically compromised patients contradicting operation.

结局指标

主要结局

palatal lengthening

时间窗: immediately postoperative

measuring the length the palate will gain using this technique

次要结局

未报告次要终点

研究者

发起方
Mahmoud Akram
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmoud Akram

Assistant lecturer of Oral and Maxillofacial surgery

Alexandria University

研究点 (1)

Loading locations...

相似试验