Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias

NCT ID: NCT05960123

Last Updated: 2023-07-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-05-30

Brief Summary

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The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).

Detailed Description

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Conditions

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Hypospadias Complication,Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group with Spongioplasty

patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement

Group Type ACTIVE_COMPARATOR

Tubularized Incised Plate (TIP) urethroplasty

Intervention Type PROCEDURE

tubularization of urethral plate with or without spongioplasty

Group without Spongioplasty

patients underwent TIPU with dorsal dartos flap interposition without spongioplasty

Group Type ACTIVE_COMPARATOR

Tubularized Incised Plate (TIP) urethroplasty

Intervention Type PROCEDURE

tubularization of urethral plate with or without spongioplasty

Interventions

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Tubularized Incised Plate (TIP) urethroplasty

tubularization of urethral plate with or without spongioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm

Exclusion Criteria

* recurrent cases Proximal; hypospadias
Minimum Eligible Age

6 Months

Maximum Eligible Age

14 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Daboos

Professor of pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohammad Daboos

Cairo, Select, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB 0000395-24-01-019

Identifier Type: -

Identifier Source: org_study_id

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