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

NCT07525570 | Completed

• 1 other identifier: MMC-HYPOSPADIAS-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypospadias; Distal Penile Hypospadias (Disorder)

Keywords

TIP urethroplasty; Tubularized incised plate; Pediatric urology; Byar's flap; Dartos flap; Hypospadias repair; Urethrocutaneous fistula; Pediatric surgery; Surgical outcomes; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Urethrocutaneous Fistula Formation

  Incidence of urethrocutaneous fistula following tubularized incised plate (TIP) urethroplasty in distal hypospadias repair. Patients were assessed during scheduled follow-up visits over 6 months. Fistula formation was confirmed by clinical examination during postoperative evaluation.

  6 months postoperatively

Secondary Outcomes (3)

• HOSE Score (Cosmetic and Functional Outcome)

  6 months postoperatively

• Parental Satisfaction Score

  6 months postoperatively

• Operative Time

  Intraoperative (during surgery)

Study Arms (2)

Double Dartos Flap Group

ACTIVE COMPARATOR

Participants in this group undergo tubularized incised plate (TIP) urethroplasty with double dartos flap coverage as a second-layer reinforcement over the neourethra for distal hypospadias repair.

Procedure: Double Dartos Flap Coverage

Double Dartos + Byar's Flap Group

EXPERIMENTAL

Participants in this group undergo tubularized incised plate (TIP) urethroplasty with double dartos flap coverage combined with Byar's flap reinforcement to provide additional vascularized tissue support over the neourethra in distal hypospadias repair.

Procedure: Byar's Flap + Double Dartos Flap

Interventions

Double Dartos Flap Coverage PROCEDURE

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.

Double Dartos Flap Group

Byar's Flap + Double Dartos Flap PROCEDURE

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.

Double Dartos + Byar's Flap Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male children aged 2-12 years Diagnosis of primary distal penile hypospadias (glanular, coronal, or subcoronal) No previous surgical repair for hypospadias Fit for general anesthesia as determined by preoperative assessment Written informed consent provided by parents or legal guardians -

You may not qualify if:

• Midshaft or proximal hypospadias Severe chordee requiring staged repair Previous penile or hypospadias surgery Associated major genital anomalies Micropenis Bleeding disorders or systemic coagulopathies Unfit for general anesthesia

Sponsors & Collaborators

• Javaid Afridi: lead

Study Sites (1)

Mardan Medical Complex, Department of Pediatric Surgery

Mardan, KPK, 22000, Pakistan

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of surgical interventions, masking was not feasible for participants or investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Surgery

Model Details: Participants were randomly assigned to one of two parallel groups receiving different surgical techniques for distal hypospadias repair. Group A underwent tubularized incised plate (TIP) urethroplasty with double dartos flap coverage, while Group B underwent TIP urethroplasty with double dartos flap combined with Byar's flap reinforcement.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: January 10, 2024
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)