NCT06343623

Brief Summary

Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

March 15, 2024

Last Update Submit

March 26, 2024

Conditions

Velopharyngeal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Improvement in the speech outcome

    Improvement in the speech outcome using auditory perception assessment and videonasoendoscopy

    4 years

Secondary Outcomes (1)

  • obstructive sleep apnea

    3 years

Study Arms (2)

superiorly based flap

ACTIVE COMPARATOR

superiorly bases pharyngeal flap

Procedure: superiorly based flap

myomucosal resection and direct closure

EXPERIMENTAL

myomucosal resection and direct closure

Procedure: myomucosal resection and direct closure

Interventions

myomucosal resection and direct closurePROCEDURE

myomucosal resection and direct closure

myomucosal resection and direct closure
superiorly based flapPROCEDURE

superiorly based pharyngeal flap

superiorly based flap

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Patients have velopharyngeal insufficiency.
  • Age range 4-10 years

You may not qualify if:

  • \- Syndromic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Velopharyngeal Insufficiency

Condition Hierarchy (Ancestors)

Mouth AbnormalitiesMouth DiseasesStomatognathic DiseasesPharyngeal DiseasesStomatognathic System AbnormalitiesOtorhinolaryngologic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of plastic surgery

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 2, 2024

Study Start

October 12, 2018

Primary Completion

October 16, 2022

Study Completion

October 16, 2022

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations

EG(1)