Fistiulation Rate Following Primary Cleft Repair≤

Cairo University (CU)

Status: Completed

Conditions: Cleft Palate

Treatments: Procedure: Bardach two flap palatoplasty; Procedure: Buccinator myomucosal flap

Study type: Interventional

Funder types: Other

Identifiers

NCT05166408

Primary palatoplasty fistula

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 9 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. patients suffering from complete wide cleft palate more than 10 mm
2. Patients age from 9 to 18 months
3. Patients free from any systemic disease that might affect normal healing or the predictable outcome
4. Patients who will agree to the consent and stick to the follow up period

Exclusion criteria

1. Patients with systemic disease
2. Patients who might not stick to the follow up period
3. Patients with Pierre Robin syndrome
4. Patients with previous palatal repair

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Buccinator myomucosal flap for primary cleft repair

Other group

Description:

Study group

Treatment:

Procedure: Buccinator myomucosal flap

Bardach two flap palatoplasty for primary cleft repair

Other group

Description:

Control group

Treatment:

Procedure: Bardach two flap palatoplasty