NCT07525570

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Javaid Afridi · Academic / Other
• Sex: Male
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypospadias is a common congenital anomaly of the male urethra requiring surgical correction, with tubularized incised plate (TIP) urethroplasty being one of the most widely used techniques for distal forms. Despite advances in surgical methods, postoperative complications such as urethrocutaneous fistula, glans dehiscence, and meatal stenosis remain clinically significant. Various tissue interposition techniques have been introduced to reduce complication rates, including the use of dartos flaps for neourethral coverage. The double dartos flap technique provides additional vascularized tissue support and has been associated with improved outcomes. However, in some cases, reinforcement with additional vascularized tissue such as Byar's flaps may further enhance healing and reduce complications. This study was designed as a prospective randomized controlled trial conducted at Mardan Medical Complex. Pediatric patients diagnosed with distal penile hypospadias were enrolled and randomly allocated into two groups. Group A underwent TIP urethroplasty with double dartos flap coverage, while Group B underwent TIP urethroplasty with double dartos flap combined with Byar's flap reinforcement. All surgeries were performed under standardized operative protocols by an experienced pediatric surgeon to minimize technical variability. Postoperative care was uniform across both groups. Patients were followed at regular intervals for a period of six months. The primary endpoint was the incidence of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary endpoints included cosmetic outcome and functional assessment of urinary stream. The aim of this study was to evaluate whether the addition of Byar's flap to standard double dartos coverage provides a statistically and clinically significant improvement in surgical outcomes following TIP urethroplasty in distal hypospadias.

Conditions

• Hypospadias
• Distal Penile Hypospadias (Disorder)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-10
• Primary completion: 2025-07-10
• Completion: 2025-07-10
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Pakistan