Clinical Trial

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

Study acronym: DD-TIP-BF
Completed
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.
Trial Details
NCT Number NCT07525570
Lead Sponsor Javaid Afridi
Conditions Hypospadias, Distal Penile Hypospadias (Disorder)
Enrollment 120 participants
Start Date 2024-01-10
Primary Completion 2025-07-10 (estimated)
Study Completion 2025-07-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-13