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Clinical Trials/NCT05196555
NCT05196555
Completed
Not Applicable

Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty

Hams Hamed Abdelrahman1 site in 1 country30 target enrollmentAugust 6, 2019
ConditionsCleft Palate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Palate
Sponsor
Hams Hamed Abdelrahman
Enrollment
30
Locations
1
Primary Endpoint
change in nasal airflow
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling

Registry
clinicaltrials.gov
Start Date
August 6, 2019
End Date
December 17, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hams Hamed Abdelrahman
Responsible Party
Sponsor Investigator
Principal Investigator

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Patients with isolated cleft palate age from 9 months to 18 years.
  • Patients with submucous cleft.
  • Velopharyngeal incompetence (VPI) for palatal re-repair.

Exclusion Criteria

  • Medically unfit patients.
  • Syndromic patients with cleft lip and palate.
  • Patients with cleft palate associated with multiple congenital anomalies.
  • Patients with neurological disorders.

Outcomes

Primary Outcomes

change in nasal airflow

Time Frame: Baseline, immediately after procedure

Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.

change in soft palate elevation

Time Frame: Baseline, immediately after procedure

Observing the range of motion of soft palate using videofluoroscopy

change in tongue motion assessment

Time Frame: Baseline, immediately after procedure

Observing the range of tongue motion using videofluoroscopy

change in lips motion assessment

Time Frame: Baseline, immediately after procedure

Observing the range of lips motion using videofluoroscopy

Study Sites (1)

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