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Not yet recruitingNCT06477679Updated Jun 27, 2024

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

An interventional study of • Furlow with buccinators myomucosal flap and • Two flap palatoplasty as von langenbeck technique in Cleft Palate, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Years and older
Sex
All
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Study 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 .

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Conditions studied

  • Cleft Palate

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03

In context

Cleft Palate

123 studies on the registry are indexed under Cleft Palate; 35 are open to participants now.

This study's planned enrollment of 50 is above the median of 44 across 77 interventional studies indexed under Cleft Palate.

Browse Cleft Palate studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • •children more than 3 years old

    • Type of cleft: isolated cleft palate

Exclusion criteria

Exclusion Criteri

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

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

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What researchers measure

Primary outcomes

  1. Velopharyngeal Insufficiency Evaluation

    Velopharyngeal gap size in centimeters using nasopharyngoscopy.

    Time frame: 20 months

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Study locations

1 site
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References and documents

Publications

  • Wong FK, Hagg U. An update on the aetiology of orofacial clefts. Hong Kong Med J. 2004 Oct;10(5):331-6. PubMed 15479962 ↗
  • 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. PubMed 17993884 ↗
  • 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. PubMed 26322283 ↗
  • 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. PubMed 24090720 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2024; primary completion for Feb 2026, 20 months later.

Of 34 non-industry interventional studies with no phase under Cleft Palate, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 20 months is above that.

Counting every sponsor, half of 34 studies reached it within 18 months; a quarter within 12 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2024
First posted
Jun 27, 2024
StartEst.
Jun 2024
Primary completionEst.
Feb 2026
CompletionEst.
Feb 2026
Last update
Jun 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06477679
Lead sponsor
Sohag University
Responsible party
Ragab Ahmed Ali (ASSISTANT LECTURE-pediatricSURGERY department-sohag university, Sohag University) — Principal investigator
First posted
Jun 27, 2024
Start date
Jun 2024 (estimated)
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Jun 27, 2024

Study contacts

Ragab A Ali, assistant lecutrer
Contact
Ragab.ahmed@med.sohag.edu.eg
01097412354
Nabil Y Salah Eidin
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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