A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature

Summary

Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis remain concerns. These complications are often influenced by the choice of intermediate tissue layer used to reinforce the neourethra. The traditional ventral dartos flap is effective but can be technically challenging and may result in a bulky tissue layer.

Platelet-rich fibrin (PRF) is an autologous, growth factor-rich biological material that has shown promise in tissue regeneration and healing. It is easy to prepare intraoperatively and may serve as a biological reinforcement to reduce postoperative complications.

This study aims to provide high-quality evidence comparing the effectiveness of PRF versus the ventral dartos flap in patients with distal hypospadias, specifically those with Grade 1 urethral defects and minimal penile curvature, using a stratified study population to ensure balanced groups.

Conditions

• PRF
• Hypospadias
• Distal Hypospadias
• Hypospadias Repair
• Fistula Stenosis
• Cosmetic Outcomes
• Functional Outcomes
• Tubularized Incised Plate

Interventions

PROCEDURE

- Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra

In this arm, a platelet-rich fibrin membrane will be prepared intraoperatively from the patient's blood using centrifugation. The prepared PRF membrane will then be applied directly over the neourethra following urethroplasty to promote healing and tissue regeneration.

PROCEDURE

Group B: Ventral dartos flap rotated over neourethra

Participants in this arm will undergo hypospadias repair with the application of a ventral dartos fascia flap. The procedure involves elevating a vascularized flap of ventral dartos fascia from the penile shaft, rotating it over the neourethra to provide additional tissue coverage and promote healing. This flap helps in reducing the risk of fistula formation and enhances vascular support to the neourethra. The surgical steps include dissecting the dartos fascia carefully, rotating it over the neourethral reconstruction, and securing it in place, followed by standard postoperative care and follow-up.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital

  collaborator OTHER

• National Children's Medical Center, Uzbekistan

  lead OTHER

Principal Investigators

• Tariq Abbas, MD, PhD · Sidra Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-05

Primary Completion

2026-06-05

Completion

2026-06-05

Countries

• Uzbekistan

Study Locations