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

Sohag University

Status: Not yet enrolling

Conditions: Cleft Palate

Treatments: Procedure: • Two flap palatoplasty as von langenbeck technique; Procedure: • Furlow with buccinators myomucosal flap

Study type: Interventional

Funder types: Other

Identifiers

NCT06477679

soh-Med-24-05-02MD

Details and patient eligibility

About

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 .

Enrollment: 50 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

group A

Active Comparator group

Description:

. 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

Treatment:

Procedure: • Furlow with buccinators myomucosal flap

group B

Active Comparator group

Description:

• 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.

Treatment:

Procedure: • Two flap palatoplasty as von langenbeck technique