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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05166408

Enrollment

Registered

2021-12-22

Start date

2019-09-24

Completion date

2021-02-05

Last updated

2021-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate

Keywords

Cleft palate, Primary repair, Buccinator flap, Palatal fistula

Brief 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.

Interventions

PROCEDUREBuccinator myomucosal flap

Buccinator myomucosal flap for primary cleft palate palatoplasty

PROCEDUREBardach two flap palatoplasty

Bardach two flap palatoplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

9 Months to 18 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026