Superiorly Based Pharyngeal Flap Versus Myomucosal Resect... | NCT06343623

Studies
Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure

NCT06343623

Sponsor

Minia University

Status

Completed

Last Update Posted

Apr 2, 2024Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Velopharyngeal Insufficiency

Interventions

myomucosal resection and direct closure
superiorly based flap

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2018Actual

Primary Completion Date

Oct 16, 2022Actual

Completion Date

Oct 16, 2022Actual

First Submitted Date

Mar 15, 2024

First Submission Date that Met QC Criteria

Mar 26, 2024

First Posted Date

Apr 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2024

Last Update Posted Date

Apr 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
myomucosal resection and direct closure	Procedure	myomucosal resection and direct closure	myomucosal resection and direct closure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in the speech outcome	Improvement in the speech outcome using auditory perception assessment and videonasoendoscopy	4 years

Secondary Outcomes

Measure	Description	Time Frame
obstructive sleep apnea	obstructive sleep apnea using respiratory function test	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Syndromic patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine		Minya		61511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D014681	Velopharyngeal Insufficiency

Ancestor Terms

ID	Term
D009056	Mouth Abnormalities
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided