Fistiulation Rate Following Primary Cleft Repair≤

Study Overview
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Brief Summary
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Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.

Detailed Description
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Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. The goal was to predict the risk of velopharyngeal insufficiency and to decrease the fistiulation rate. Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length from anterior reference point(incisive foramen) to posterior reference point(uvula) and calculation of change in palatal length.

Official Title
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A Novel Technique Predicting Velopharyngeal Insufficiency Risk in Newborns Following Primary Cleft Repair. A Randomised Clinical Trial Comparing Buccinator Flap and Bardach; Two-flap Palatoplasty.

Conditions
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Cleft Palate

Intervention / Treatment
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* Procedure: Buccinator myomucosal flap
* Procedure: Bardach two flap palatoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from complete wide cleft palate more than 10 mm Patients age from 9 to 18 months Patients free from any systemic disease that might affect normal healing or the predictable outcome Patients who will agree to the consent and stick to the follow up period Exclusion Criteria: Patients with systemic disease Patients who might not stick to the follow up period Patients with Pierre Robin syndrome Patients with previous palatal repair

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Buccinator myomucosal flap for primary cleft repair<br>Study group | Procedure: Buccinator myomucosal flap<br>* Buccinator myomucosal flap for primary cleft palate palatoplasty<br>|
| Other: Bardach two flap palatoplasty for primary cleft repair<br>Control group | Procedure: Bardach two flap palatoplasty<br>* Bardach two flap palatoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistiulation rate | The rate of palatal fistula formation following primary cleft palate repair ( number of patients complicated with palatal fistula compared to the full patients number) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatal length & risk of VPI | The length of soft palate after surgical repair in correlation with the risk of future velopharyngeal insufficiency ( linear scale) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cleft palate, Primary repair, Buccinator flap, Palatal fistula