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COMPLETED
NCT07525570
NA

Effect of Adding Byar's Flap to Double Dartos Coverage in TIP Urethroplasty for Distal Hypospadias: A Randomized Trial

Sponsor: Javaid Afridi

View on ClinicalTrials.gov

Summary

This randomized controlled trial evaluates the effect of adding Byar's flap in combination with double dartos flap coverage during tubularized incised plate (TIP) urethroplasty in children with distal hypospadias. The study compares surgical outcomes between two techniques: TIP urethroplasty with double dartos coverage alone versus TIP urethroplasty with double dartos plus Byar's flap reinforcement. The primary outcome is the rate of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary outcomes include cosmetic outcome assessment and functional results using validated scoring systems. Patients diagnosed with distal penile hypospadias were randomly assigned to either surgical group. All procedures were performed by an experienced pediatric surgeon under standardized operative conditions. Follow-up assessments were conducted over a 6-month postoperative period to evaluate early and intermediate surgical outcomes. The objective of this study is to determine whether the addition of Byar's flap provides superior surgical outcomes compared to standard double dartos coverage in TIP urethroplasty.

Official title: Double Dartos Versus Double Dartos Plus Byars' Flap in TIP Urethroplasty for Distal Hypospadias: A Randomized Controlled Trial

Key Details

Gender

MALE

Age Range

2 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-01-10

Completion Date

2025-07-10

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

PROCEDURE

Double Dartos Flap Coverage

A vascularized dartos fascia flap is harvested and used as a second-layer coverage over the neourethra following tubularized incised plate (TIP) urethroplasty to reduce postoperative complications such as urethrocutaneous fistula.

PROCEDURE

Byar's Flap + Double Dartos Flap

Byar's flaps are created from preputial skin and combined with double dartos flap coverage to reinforce the neourethral repair after tubularized incised plate (TIP) urethroplasty in distal hypospadias.

Locations (1)

Mardan Medical Complex, Department of Pediatric Surgery

Mardan, KPK, Pakistan