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

June 26, 2024 updated by: Ragab Ahmed Ali, Sohag University

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nabil Y Salah Eidin

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
. 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
• 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
Active Comparator: group B
• 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
• 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Velopharyngeal Insufficiency Evaluation
Time Frame: 20 months
Velopharyngeal gap size in centimeters using nasopharyngoscopy.
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-24-05-02MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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