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The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial

NCT ID: NCT05123833

Last Updated: 2021-11-17

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-08-01

Brief Summary

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To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.

Detailed Description

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Conditions

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Pediatric Disorder Hypospadias Congenital Hypospadia Urologic Diseases

Keywords

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Hypospadias repair Tunica Vaginalis Flap Dartos Fascia Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dartos Fascia

Dartos flap is used as a covering layer for urethra during repair of hypospadias

Group Type ACTIVE_COMPARATOR

Hypospadias repair

Intervention Type PROCEDURE

surgical repair of hypospadias

Tunica Vaginalis

Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias

Group Type ACTIVE_COMPARATOR

Hypospadias repair

Intervention Type PROCEDURE

surgical repair of hypospadias

Interventions

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Hypospadias repair

surgical repair of hypospadias

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 6 months.
* Distal, mid-shaft penile hypospadias.

Exclusion Criteria

* Glanular hypospadias.
* Penoscrotal, Scrotal \& Perineal hypospadias.
* Recurrent cases.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Hypospadias-UC

Identifier Type: -

Identifier Source: org_study_id