Fistiulation Rate Following Primary Cleft Repair≤

Cleft Palate Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166408
• Other study ID #: Primary palatoplasty fistula
• Status: Completed
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: February 5, 2021

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 5, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Procedure:
• Buccinator myomucosal flap
Buccinator myomucosal flap for primary cleft palate palatoplasty
• Bardach two flap palatoplasty
Bardach two flap palatoplasty

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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