Actively Recruiting

Phase Not Applicable
Age: 6Months - 84Months
MALE
NCT07319780

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

Led by National Children's Medical Center, Uzbekistan · Updated on 2026-01-30

100

Participants Needed

2

Research Sites

155 weeks

Total Duration

On this page

Sponsors

N

National Children's Medical Center, Uzbekistan

Lead Sponsor

D

Dr Cipto Mangunkusumo General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

Who Can Participate

Age: 6Months - 84Months
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male children aged 6 months to 84 months
  • Primary or redo distal hypospadias
  • Unfavorable urethral plate
  • Penile curvature less than 45 degrees after degloving
  • Eligible for tubularized incised plate urethroplasty
Not Eligible

You will not qualify if you...

  • 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
  • Known bleeding or platelet disorders
  • Inability to comply with postoperative follow-up

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Dr. Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia, 10430

Not Yet Recruiting

2

National Children's Medical Center

Tashkent, Tashkent, Uzbekistan, 100020

Actively Recruiting

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Research Team

Z

Zafar Abdullaev, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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