NCT05166408

Fistiulation Rate Following Primary Cleft Repair≤

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 9 Months – 18 Months
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Cleft Palate

Interventions

Type	Name	Description
PROCEDURE	Buccinator myomucosal flap	Buccinator myomucosal flap for primary cleft palate palatoplasty
PROCEDURE	Bardach two flap palatoplasty	Bardach two flap palatoplasty

Timeline

• Start date: 2019-09-24
• Primary completion: 2021-01-01
• Completion: 2021-02-05
• First posted: 2021-12-22
• Last updated: 2021-12-22

Locations

1 site across 1 country: Egypt