Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure

NCT ID: NCT06343623

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2022-10-16

Brief Summary

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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

Detailed Description

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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

Conditions

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Velopharyngeal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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superiorly based flap

superiorly bases pharyngeal flap

Group Type ACTIVE_COMPARATOR

superiorly based flap

Intervention Type PROCEDURE

superiorly based pharyngeal flap

myomucosal resection and direct closure

myomucosal resection and direct closure

Group Type EXPERIMENTAL

myomucosal resection and direct closure

Intervention Type PROCEDURE

myomucosal resection and direct closure

Interventions

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myomucosal resection and direct closure

myomucosal resection and direct closure

Intervention Type PROCEDURE

superiorly based flap

superiorly based pharyngeal flap

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \- Syndromic patients.
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mstafa Hassan Sewefy

professor of plastic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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fac.med.2018.15

Identifier Type: -

Identifier Source: org_study_id

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