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NCT05960123 Clinical Trial

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

Hypospadias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05960123
Other study ID # IRB 0000395-24-01-019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date May 30, 2023

Study information
Verified date July 2023
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date May 30, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 6 Months to 14 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Tubularized Incised Plate (TIP) urethroplasty
tubularization of urethral plate with or without spongioplasty

Locations
Country Name City State
Egypt Mohammad Daboos Cairo Select

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other Cosmetic results Hypospadias Objective Scoring Evaluation (maximum the best is 16 points ) and minimum the worst is 4 12 months
Primary Urethrocutaneous fistula Rate of fistula 12 months
Primary meatal stenosis Rate of metal stenosis 12 months
Primary glans dehiscence Rate of glans dehiscence 12 months
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Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
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Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A
Suspended NCT05708989 - Caudal vs. Pudendal Block in Peds GU Phase 4
Completed NCT02593903 - Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair N/A