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

Not Applicable

Completed

• Conditions: Hypospadias; Complication,Postoperative
• Interventions: Procedure: Tubularized Incised Plate (TIP) urethroplasty

• Registration Number: NCT05960123
• Lead Sponsor: Al-Azhar University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-05-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group without Spongioplasty	Tubularized Incised Plate (TIP) urethroplasty	patients underwent TIPU with dorsal dartos flap interposition without spongioplasty
Group with Spongioplasty	Tubularized Incised Plate (TIP) urethroplasty	patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement

Primary Outcome Measures

Name	Time	Method
Urethrocutaneous fistula	12 months	Rate of fistula
glans dehiscence	12 months	Rate of glans dehiscence
meatal stenosis	12 months	Rate of metal stenosis

Trial Locations

Locations (1)

Mohammad Daboos; 🇪🇬 Cairo, Select, Egypt