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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

June 5, 2025

Primary Completion Date

June 5, 2026

Study Completion Date

June 5, 2026

Conditions
PRFHypospadiasDistal HypospadiasHypospadias RepairFistula StenosisCosmetic OutcomesFunctional OutcomesTubularized 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.

Trial Locations (1)

100020

National Children's Medical Center, Tashkent

All Listed Sponsors
collaborator

Dr Cipto Mangunkusumo General Hospital

OTHER

lead

National Children's Medical Center, Uzbekistan

OTHER