Fistiulation Rate Following Primary Cleft Repair≤

Not Applicable

Completed

• Conditions: Cleft Palate
• Interventions: Procedure: Bardach two flap palatoplasty; Procedure: Buccinator myomucosal flap

• Registration Number: NCT05166408
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2019-09-24
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-05
• Status Verified: 2021-12
• Study First Submitted: 2021-12-05
• Study First Submitted QC: 2021-12-19
• Last Update Submitted: 2021-12-19
• Study First Posted: 2021-12-22
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bardach two flap palatoplasty for primary cleft repair	Bardach two flap palatoplasty	Control group
Buccinator myomucosal flap for primary cleft repair	Buccinator myomucosal flap	Study group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt