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Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty

Velopharyngeal Insufficiency Evaluation Post Cleft Palate Repair. Furlow With Buccinator Myomucosal Flap Versus Two Flap Palatoplasty

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06477679
Enrollment
50
Registered
2024-06-27
Start date
2024-06-30
Completion date
2026-02-28
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate

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 .

Interventions

PROCEDURE• Furlow with buccinators myomucosal flap

• Furlow with buccinators myomucosal flap. Two opposing Z-plasties were designed on the oral and nasal mucosal surface. The posterior based flap on each surface was composed of muscle and mucosa, and the anterior surface was composed of mucosa only. BMFs were raised from the donor site, and immediately transferred to the recipient site to repair the defect. The flaps were sutured to the recipient site. The donor site was also closed primarily

PROCEDURE• Two flap palatoplasty as von langenbeck technique

• Two flap palatoplasty as von langenbeck technique, Upper left: Medial incisions design. Upper right: Lateral relaxing incisions and nasal mucosa closure using the anterior triangular flap and lateral nasal mucosa flaps. Release of the abnormal muscular insertion is performed. But two flap palatoplasty can lengthen the soft palate by push-back

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Velopharyngeal Insufficiency Evaluation20 monthsVelopharyngeal gap size in centimeters using nasopharyngoscopy.

Countries

Egypt

Contacts

Primary ContactRagab A Ali, assistant lecutrer
Ragab.ahmed@med.sohag.edu.eg01097412354
Backup ContactNabil Y Salah Eidin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026