Clinical trial NCT06477679: Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty
Official title: Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cleft Palate
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility criteria: Inclusion Criteria:

* •children more than 3 years old

  * Type of cleft: isolated cleft palate

Exclusion Criteri

* Complicated cases by fistula or redo,
* Missed follow up; less than 6 months.

Primary outcomes:
measure: Velopharyngeal Insufficiency Evaluation
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Wong FK, Hagg U. An update on the aetiology of orofacial clefts. Hong Kong Med J. 2004 Oct;10(5):331-6.
citation: Donkor P, Bankas DO, Agbenorku P, Plange-Rhule G, Ansah SK. Cleft lip and palate surgery in Kumasi, Ghana: 2001-2005. J Craniofac Surg. 2007 Nov;18(6):1376-9. doi: 10.1097/01.scs.0000246504.09593.e4.
citation: Abdaly H, Omranyfard M, Ardekany MR, Babaei K. Buccinator flap as a method for palatal fistula and VPI management. Adv Biomed Res. 2015 Jul 27;4:135. doi: 10.4103/2277-9175.161529. eCollection 2015.
citation: Bishop A, Hong P, Bezuhly M. Autologous fat grafting for the treatment of velopharyngeal insufficiency: state of the art. J Plast Reconstr Aesthet Surg. 2014 Jan;67(1):1-8. doi: 10.1016/j.bjps.2013.09.021. Epub 2013 Sep 20.