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RECRUITING
NCT07319780
NA

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

Sponsor: National Children's Medical Center, Uzbekistan

View on ClinicalTrials.gov

Summary

Hypospadias is a common congenital condition in boys in which the opening of the urethra is located on the underside of the penis. Distal hypospadias is the most common form and is usually treated surgically using tubularized incised plate (TIP) urethroplasty. In boys with an unfavorable urethral plate, graft-augmented techniques (G-TIP) are often used; however, postoperative complications such as urethrocutaneous fistula and narrowing of the urethral opening (meatal stenosis) may still occur. Platelet-rich fibrin (PRF) is a biological material obtained from the patient's own blood that contains natural growth factors and may help improve tissue healing. This study aims to evaluate whether the use of PRF during surgery can reduce postoperative complications and improve surgical outcomes in children undergoing hypospadias repair.

Official title: A Multicenter Randomized Controlled Trial Comparing Fibrin-Enhanced Tubularized Incised Plate (F-TIP) and Grafted Tubularized Incised Plate (G-TIP) Urethroplasty in Distal Hypospadias With Unfavorable Urethral Plates

Key Details

Gender

MALE

Age Range

6 Months - 84 Months

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-05

Completion Date

2028-12-25

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

PROCEDURE

Fibrin-Enhanced TIP Urethroplasty

Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.

PROCEDURE

Grafted TIP Urethroplasty

Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.

Locations (2)

Dr. Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

National Children's Medical Center

Tashkent, Tashkent, Uzbekistan