• Fistula Formation in Patients With Cleft Palate Following Primary Furlow Palatoplasty With Buccal Myomucosal Flap Versus Two Flap Palatoplasty
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
干预措施: furlow with buccinator (Procedure)
two flap palatoplasty
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
Shaimaa Mohsen
associate professor
Fayoum University
