Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-84
SponsorNational Children's Medical Center, Uzbekistan

About this trial

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.

Eligibility criteria

Qualifiers

Male children aged 6 months to 84 months

Primary or redo distal hypospadias

Unfavorable urethral plate

Penile curvature less than 45 degrees after degloving

Disqualifiers

Disorders of sex development or ambiguous genitalia

Severe penile curvature requiring urethral plate transection

Previous graft-based urethroplasty

Active local or systemic infection at the time of surgery

Trial design

Treatments tested in this trial

  • Fibrin-Enhanced TIP Urethroplasty
  • Grafted TIP Urethroplasty

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Children's Medical Center, Uzbekistan

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Collaborator