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.

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate
• Intervention / Treatment: Procedure: Buccinator myomucosal flap; Procedure: Bardach two flap palatoplasty

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Buccinator myomucosal flap for primary cleft repair; Study group	Procedure: Buccinator myomucosal flap; Buccinator myomucosal flap for primary cleft palate palatoplasty
Other: Bardach two flap palatoplasty for primary cleft repair; Control group	Procedure: Bardach two flap palatoplasty; Bardach two flap palatoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Wael Abdelsamee, Research organizer

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: December 19, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Cleft palate; Primary repair; Buccinator flap; Palatal fistula
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: Primary palatoplasty fistula

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No