Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI

NCT ID: NCT05626933

Last Updated: 2022-11-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2023-01-02

Brief Summary

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Nasopharyngoscopic examination of the 20 patients with secondary VPI following 2 flap palatoplasty will be done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap and after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty

Detailed Description

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Conditions

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Velopharyngeal Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buccinator myomucosal flap with Furlow palatoplasty

Group Type EXPERIMENTAL

Buccinator myomucosal flap with Furlow palatoplasty

Intervention Type PROCEDURE

Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes

Interventions

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Buccinator myomucosal flap with Furlow palatoplasty

Anatomical restoration concept using Buccinator myomucosal flap with Furlow palatoplasty is an effective technique for lengthening the palate and improving speech outcomes

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.
* lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria

* Patients with syndromic cleft lip.
* Bilateral cleft lip
* Patient older younger 5 years.
* Associated Cardiac anomalies.
* Any systemic condition
Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohsen

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fayoum University

Al Fayyum, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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shaimaa refahee, phd

Role: CONTACT

01227407987

mamdouh aboelhassan, phd

Role: CONTACT

Facility Contacts

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shaimaa refahee, phd

Role: primary

01227407987

References

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Aboulhassan MA, Elrouby IM, Refahee SM, Abd-El-Ghafour M. Effectiveness of secondary furlow palatoplasty with buccal myomucosal flap in correction of velopharyngeal insufficiency in patients with cleft palate. Clin Oral Investig. 2024 Apr 17;28(5):257. doi: 10.1007/s00784-024-05607-4.

Reference Type DERIVED
PMID: 38630186 (View on PubMed)

Other Identifiers

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EC 2222

Identifier Type: -

Identifier Source: org_study_id

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