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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 6 months
Maximum Age: 7
Healthy Volunteers: f
View:

• Male children aged 6 months to 84 months

• Primary or redo distal hypospadias

• Unfavorable urethral plate

• Penile curvature less than 45 degrees after degloving

• Eligibility for tubularized incised plate urethroplasty

Locations
Other Locations
Indonesia
Dr. Cipto Mangunkusumo Hospital
NOT_YET_RECRUITING
Jakarta
Uzbekistan
National Children's Medical Center
RECRUITING
Tashkent
Contact Information
Primary
Zafar Abdullaev, MD PhD
Abdullaev.med@gmail.com
+998-90-909-9911
Time Frame
Start Date: 2026-01-05
Estimated Completion Date: 2028-12-25
Participants
Target number of participants: 100
Treatments
Experimental: F-TIP Urethroplasty
Participants will undergo fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty. Autologous platelet-rich fibrin will be prepared intraoperatively and applied to the incised urethral plate and fixed with PDS 6/0-7/0 suture prior to tubularization.
Active_comparator: G-TIP Urethroplasty
Participants will undergo grafted tubularized incised plate (G-TIP) urethroplasty using standard graft augmentation techniques for unfavorable urethral plates.
Related Therapeutic Areas
Sponsors
Leads: National Children's Medical Center, Uzbekistan
Collaborators: Dr Cipto Mangunkusumo General Hospital

This content was sourced from clinicaltrials.gov

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