MRI Assessment of Velopharyngeal Anatomy in Late Primary Cleft Palate Repair Using Modified Furlow With Buccinator Myomucosal Flap: A Case Series Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Velopharyngeal assessment
研究概览
简要总结
The goal of this case series study is to learn if magnetic resonance imaging (MRI) can show how well the palate and throat muscles work at rest and during speech after late cleft palate repair. The surgery uses a technique in which the muscle from the cheek is used to close the gap and repair the cleft and therefore improve speech. The study will answer the question of whether this technique will provide better closure and improved speech in the participants who have not received early treatment. The participants will have the surgery and then have MRI scans 6 months after surgery while resting and speaking specific sounds. Complete speech assessments will also be done 6 months after surgery.
详细描述
This study will include about 10 children, age 5 years and older, with cleft palate who have not had previous palate surgery. All participants will have surgery using the modified Furlow palatoplasty with a buccinator myomucosal flap. This method is designed to improve muscle function and speech outcomes in children who have late cleft palate repair.
Six months after surgery, participants will have MRI scans. The scans will take pictures of the palate and throat muscles while resting and while saying sounds such as "EEE" and "SSS." These images will help researchers see how well the muscles close the gap between the nose and mouth during speech.
Participants will also have a speech evaluation six months after surgery. This will include articulation tests and scoring of speech clarity and nasal resonance.
The study will take place at Cairo University and New Giza University Hospital. By combining MRI results with speech assessments, researchers aim to show whether MRI is a useful tool for evaluating muscle function after this type of cleft palate repair. The findings may help guide future treatment for children who cannot have early surgery.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-syndromic cleft palate (La Veau I-IV)
- •No prior palatal surgery
- •Consent for MRI and follow-up
排除标准
- •Syndromic clefts or associated craniofacial anomalies.
- •Systemic co-morbidities
- •Previous palatal surgery.
- •Contraindications to MRI.
研究组 & 干预措施
Cleft palate group
Patients undergoing late primary cleft palate repair with Modified Furlow Palatoplasty combined with buccinator myomucosal flap
干预措施: Modified Furlow Palatoplasty combined with buccinator myomucosal flap (Procedure)
结局指标
主要结局
Velopharyngeal assessment
时间窗: 6 Months
The points measured to assess velopharyngeal anatomy are: Velar Length Pharyngeal Depth, Effective Velar length, Velar thickness, VP Gap. All measurements will be in mm. 3D T2-weighted sequence is used to capture high-resolution anatomical details at rest. Rapid 2D sequences assess velopharyngeal closure during sustained phonation. Sagittal and oblique coronal views will be captured. The sagittal plane provides an overall view of velopharyngeal structures, while the oblique coronal plane is specifically designed to visualize the LVP and assess closure pattern. Measurements on the MRI will be taken by primary and secondary raters to examine the intra- and inter-observer reliability. All patients will have their MRI taken with the same machine with uniform MRI acquisition parameters
VP ratio
时间窗: 6 months
this is a ratio calculated by dividing Velar length/Pharyngeal depth.
EVP ratio
时间窗: 6 months
This is a ratio calculated by dividing Effective Velar length/Pharyngeal depth
次要结局
- Speech intelligibility(6 months after surgery)
- Hypernasality(6 months after surgery)
- Nasal emission(6 months after surgery)
研究者
Dina Adel
Assistant lecturer of oral and maxillofacial surgery
Cairo University