Fistiulation Rate Following Primary Cleft Repair≤

Cairo University46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cleft Palate

Interventions

Buccinator myomucosal flapPROCEDURE

Buccinator myomucosal flap for primary cleft palate palatoplasty

Bardach two flap palatoplastyPROCEDURE

Bardach two flap palatoplasty

Eligibility

Sex: ALLMin age: 9 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Secondary Outcomes

Palatal length & risk of VPI

The length of soft palate after surgical repair in correlation with the risk of future velopharyngeal insufficiency ( linear scale)

Time frame: 6 months

Data from ClinicalTrials.gov

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