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NCT Number: NCT07525570

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 -

Exclusion criteria

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

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Treatment and study plan

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.

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.

Primary outcomes

  1. Urethrocutaneous Fistula Formation

    Time frame: 6 months postoperatively

    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.

Secondary outcomes

  1. HOSE Score (Cosmetic and Functional Outcome)

    Time frame: 6 months postoperatively

    Cosmetic and functional outcome was assessed using the Hypospadias Objective Scoring Evaluation (HOSE) system at 6-month follow-up. Scores were compared between both surgical groups.

  2. Parental Satisfaction Score

    Time frame: 6 months postoperatively

    Parental satisfaction with surgical outcome was assessed using a standardized satisfaction scale at 6-month follow-up. Scores were analyzed between both groups.

  3. Operative Time

    Time frame: Intraoperative (during surgery)

    Total operative time was recorded from skin incision to completion of wound closure in minutes for each surgical group.

Sponsors and collaborators

Lead sponsor

Javaid Afridi

Other

Registry information

Official study title

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

Acronym: DD-TIP-BF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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