Distal Hypospadias, Hypospadias
Conditions
Keywords
Hypospadias repair, Tubularized incised plate, Platelet-rich fibrin, PRF, Grafted TIP, Pediatric urology
Brief 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.
Detailed description
This is a prospective, multicenter, single-blinded randomized controlled trial designed to compare fibrin-enhanced tubularized incised plate (F-TIP) urethroplasty using autologous platelet-rich fibrin (PRF) with grafted tubularized incised plate (G-TIP) urethroplasty in children with distal hypospadias and an unfavorable urethral plate. Male children aged 6 months to 84 months with primary or redo distal hypospadias and mild penile curvature will be eligible for inclusion. Participants will be randomized in a 1:1 ratio to undergo either F-TIP urethroplasty with intraoperative application of autologous PRF or standard G-TIP urethroplasty without PRF. Autologous PRF will be prepared intraoperatively from the patient's peripheral blood using a standardized centrifugation protocol and applied to the incised urethral plate prior to tubularization. Participants will be followed postoperatively for the assessment of surgical complications, functional outcomes, and cosmetic results according to predefined outcome measures.
Interventions
PROCEDUREFibrin-Enhanced TIP Urethroplasty
Tubularized incised plate urethroplasty augmented with autologous platelet-rich fibrin membrane applied to the incised urethral plate prior to tubularization.
PROCEDUREGrafted TIP Urethroplasty
Graft-augmented tubularized incised plate urethroplasty performed using standard surgical techniques for unfavorable urethral plates.
Sponsors
National Children's Medical Center, Uzbekistan
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
6 Months to 84 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative urethral complications | 6 months postoperatively | Incidence of postoperative urethral complications, defined as the occurrence of meatal stenosis requiring dilation or surgical intervention and/or urethrocutaneous fistula identified on clinical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of urethral stricture | 6 months postoperatively | Presence of urethral stricture confirmed clinically or by imaging during follow-up. |
| Cosmetic outcome assessed by HOSE score | 6 months postoperatively | Standardized postoperative photographs were assessed by two blinded external pediatric urologists using the Hypospadias Objective Scoring Evaluation (HOSE) system. HOSE scores range from 5 to 16 points, with higher scores indicating better cosmetic outcomes. |
| Maximum urinary flow rate (Qmax) | 6 months postoperatively | Maximum urinary flow rate (Qmax), measured in milliliters per second (mL/s), assessed by uroflowmetry. Higher values indicate better urinary flow. |
Countries
Indonesia, Uzbekistan
Contacts
CONTACTZafar Abdullaev, MD PhD
PRINCIPAL_INVESTIGATORZafar Abdullaev, MD, PhD
National Children's Medical Center, Tashkent, Uzbekistan
Outcome results
None listed