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.
Non-syndromic cleft palate (La Veau I-IV)
No prior palatal surgery
Consent for MRI and follow-up
Syndromic clefts or associated craniofacial anomalies.
Systemic co-morbidities
Previous palatal surgery.
Contraindications to MRI.
Single group
Modified Furlow Palatoplasty combined with buccinator myomucosal flap
Procedure/SurgeryThe procedure is performed under general anesthesia. After marking a palatal Z-plasty and infiltrating local anesthetic, the parotid duct and buccinator flap donor site are identified. On the left side, a posteriorly based oral myomucosal flap and an anteriorly based nasal flap are created by incising from the uvula to the hard-soft palate junction and laterally toward the hamulus. The levator muscle is fully detached. A small anteriorly based nasal flap is added. On the right side, an anteriorly based oral flap and a posteriorly based nasal myomucosal flap are raised with complete muscle disinsertion. The nasal Z-plasty is interdigitated and sutured, and the oral Z-plasty is closed with minimal muscle overlap. The remaining defect is filled with a right buccal myomucosal flap, which is elevated, tunneled to the palate, inset, and the donor site closed.
Velopharyngeal assessment
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
this is a ratio calculated by dividing Velar length/Pharyngeal depth.
EVP ratio
This is a ratio calculated by dividing Effective Velar length/Pharyngeal depth
Speech intelligibility
By Standardized articulation tests, speech intelligibility will be scored according to speech intelligibility scale, ranged from 0 to 3 (0 = within normal limits, 1 = mild speech intelligibility, 2 = moderate speech intelligibility, 3 = severe speech
Hypernasality
By Perceptual speech evaluation which will be done by the same speech pathologist for all patients. Perceptual speech assessment will be performed by recording the repeated different syllables, sentences and counting from 1 to 10 by the patients in a soundproof room. All the used sentences will be in Arabic language. The records will be assessed by the phoniatrician to detect the speech disorders as the severity of nasal resonance. the severity of nasal resonance will be scored according to the hypernasality scale ranged from 0 to 3 (0 = no hyper nasality, 1 = mild hypernasality, 2 = moderate hypernasality, 3 = severe hypernasality)
Nasal emission
By Perceptual speech evaluation and will be evaluated qualitatively as absent or present.
Click on the lead sponsor to view all of their trials.
Cairo University
Lead sponsor
NewGiza University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
