跳至主要内容
临床试验/NCT07840911
NCT07840911尚未招募不适用

• Fistula Formation in Patients With Cleft Palate Following Primary Furlow Palatoplasty With Buccal Myomucosal Flap Versus Two Flap Palatoplasty

Fayoum University0 个研究点目标入组 20 人开始时间: 2026年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
fistula formation

研究概览

简要总结

Furlow with buccal myomucosal flap (group 1) Local anesthesia with a vasoconstrictor will be injected at the beginning of the surgery after Z- flap outline marking. On the left side, myomucosal posteriorly based flap will be incised containing the levator palateni muscle with a 60◦ angle and elevated. Another small anteriorly-based nasal mucosa flap will be created. On the opposite side, oral mucosal anteriorly based flap with a 90◦ angle will be incised and elevated. Palatal muscle will be stripped and posteriorly based myomucosal flap was created containing palatal muscle and nasal mucosa. Nasal mucosa will be sutured followed by oral mucosa with minimal palatal muscle overlapping. The oral mucosa defect will be filled with BMMF Two flap palatoplasty surgical steps (group 2) A bilateral tongue like palatal flaps will be incised and elevated from the incisive foramen anteriorly to the hamulus posteriorly medial to the teeth and extended around the cleft area. Palatal muscles will be detached from the palatal shelves and separating it from the nsal mucosa. Nasal layer will be the firstly closed, followed by the muscle and oral mucosal layers. In case of the presence of a bare area of bone, it will be left to heal by secondary intention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, 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
否

入选标准

  • •9-12 months old childreen with complete cleft lip and palate, nonsyndromic.
  • •lip and palate repair performed by one craniofacial surgeon

排除标准

  • •Patients with syndromic cleft lip.
  • •Redu cases
  • •Bilateral cleft lip
  • •Associated Cardiac anomalies.
  • •Any systemic condition

研究组 & 干预措施

furlow with buccinator

Experimental

干预措施: furlow with buccinator (Procedure)

two flap palatoplasty

Active Comparator

干预措施: two flap palatoplasty (Procedure)

结局指标

主要结局

fistula formation

时间窗: 6 months postoperative

assessment the fistula formation after cleft palate repair by determination the site of fistula and time at which appear

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Mohsen

associate professor

Fayoum University

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