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

NCT06477679 | Not Yet Recruiting

• 1 other identifier: soh-Med-24-05-02MD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

• Velopharyngeal Insufficiency Evaluation

  Velopharyngeal gap size in centimeters using nasopharyngoscopy.

  20 months

Study Arms (2)

group A

ACTIVE COMPARATOR

. 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: • Furlow with buccinators myomucosal flap

group B

ACTIVE COMPARATOR

• 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.

Procedure: • Two flap palatoplasty as von langenbeck technique

Interventions

• Furlow with buccinators myomucosal flap PROCEDURE

• 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

group A

• Two flap palatoplasty as von langenbeck technique PROCEDURE

• 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

group B

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• children more than 3 years old
• Type of cleft: isolated cleft palate
• Complicated cases by fistula or redo,
• Missed follow up; less than 6 months.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

• Wong FK, Hagg U. An update on the aetiology of orofacial clefts. Hong Kong Med J. 2004 Oct;10(5):331-6.

  PMID: 15479962 BACKGROUND

• 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.

  PMID: 17993884 BACKGROUND

• 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.

  PMID: 26322283 BACKGROUND

• 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.

  PMID: 24090720 BACKGROUND

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ragab A Ali, assistant lecutrer

CONTACT

01097412354; Ragab.ahmed@med.sohag.edu.eg

Nabil Y Salah Eidin

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT LECTURE-pediatricSURGERY department-sohag university

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 27, 2024
• Study Start: June 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

EG (1)