Cleft Palate With Intravelar Veloplasty Repair

Study Overview
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Brief Summary
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Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling

Official Title
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Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty

Conditions
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Cleft Palate

Intervention / Treatment
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* Procedure: Repair of cleft palate with intravelar veloplasty (IVVP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with isolated cleft palate age from 9 months to 18 years. Patients with submucous cleft. Velopharyngeal incompetence (VPI) for palatal re-repair. Exclusion Criteria: Medically unfit patients. Syndromic patients with cleft lip and palate. Patients with cleft palate associated with multiple congenital anomalies. Patients with neurological disorders.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP)<br> | Procedure: Repair of cleft palate with intravelar veloplasty (IVVP)<br>* A triangular flap is designed comprising new epithelial tissue which will be turned over to help close the nasal mucosa. Using a single hook, the oral mucosa and gland layer is separated from the muscle layer. Dissection of the greater palatine nerve-vessel bundle. The anterior palatal flap is raised by a curved elevator. The closure of the nasal mucosa and muscle is completed. Dissection of Velo Palatine Levator begins from the posterior rim of muscle and 5 mm from the midline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in soft palate elevation | Observing the range of motion of soft palate using videofluoroscopy | Baseline, immediately after procedure | 
| change in tongue motion assessment | Observing the range of tongue motion using videofluoroscopy | Baseline, immediately after procedure | 
| change in lips motion assessment | Observing the range of lips motion using videofluoroscopy | Baseline, immediately after procedure | 
| change in nasal airflow | Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow. | Baseline, immediately after procedure |