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Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias

NCT07319780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Distal Hypospadias
  • Hypospadias

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.

Sponsors & Collaborators

  • Dr Cipto Mangunkusumo General Hospital

    collaborator OTHER

  • National Children's Medical Center, Uzbekistan

    lead OTHER

Principal Investigators

  • Zafar Abdullaev, MD, PhD · National Children's Medical Center, Tashkent, Uzbekistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
84 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2028-07-05
Completion
2028-12-25

Countries

  • Indonesia
  • Uzbekistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319780 on ClinicalTrials.gov