Viewing Study NCT06477679



Ignite Creation Date: 2024-07-17 @ 10:52 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06477679
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-27
First Post: 2024-06-10

Brief Title: Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty
Sponsor: Sohag University
Organization: Sohag University

Study Overview

Official Title: Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Cleft palate is one of the most common congenital abnormalities of the orofacial region throughout the world This condition can cause facial deformity feeding problems frequent middle ear infections dental defects speech abnormalities and emotional problems Early surgical repair of this congenital anomaly prevents the psychological and functional problems associated with the deformity Patients may develop various complications after primary palatoplasty including palatal fistula and velopharyngeal insufficiency VPI which are relatively common

The main goal of cleft palate repair is to achieve normal speech and adequate velopharyngeal function with minimal effect on facial growth The primary objective in the surgical repair of a cleft palate is the development of normal speech Speech quality remains the most important standard for assessing clinical outcomes and the success of surgical procedures Many surgical techniques for palate correction have been described determining the most effective technique for the surgical repair of palatal clefts continues to cause controversy

The incidence of VPI post cleft palate repair is 20-30 of patients If there is significant velopharyngeal dysfunction during normal speech development many children learn to compensate for the lack of intraoral pressure They produce a hoarse voice because of vocal fold adduction and sudden release Compared with the adductor vocal fold palsy
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None