A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Hypospadias Cosmetic Score (HOSE)
Study Overview
Brief Summary
Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis remain concerns. These complications are often influenced by the choice of intermediate tissue layer used to reinforce the neourethra. The traditional ventral dartos flap is effective but can be technically challenging and may result in a bulky tissue layer.
Platelet-rich fibrin (PRF) is an autologous, growth factor-rich biological material that has shown promise in tissue regeneration and healing. It is easy to prepare intraoperatively and may serve as a biological reinforcement to reduce postoperative complications.
This study aims to provide high-quality evidence comparing the effectiveness of PRF versus the ventral dartos flap in patients with distal hypospadias, specifically those with Grade 1 urethral defects and minimal penile curvature, using a stratified study population to ensure balanced groups.
Detailed Description
This randomized controlled trial aims to compare the incidence of urethrocutaneous fistula at a minimum of 6 months postoperatively between two intermediate layers used in hypospadias repair: platelet-rich fibrin (PRF) membrane and ventral dartos flap. The study will also evaluate secondary outcomes, including rates of meatal stenosis, urethral stricture, other postoperative complications, and cosmetic outcomes assessed by standardized photographs and blinded expert scoring.
Study Design and Setting:
This prospective, multicenter, single-blinded randomized controlled trial will be conducted at centers in Tashkent, Uzbekistan, and Jakarta, Indonesia. A total of 140 patients (70 per group) will be enrolled, with randomization stratified by urethral plate score and center to ensure balanced groups.
Participants:
Children aged 6 months to 5 years with primary distal hypospadias (Grade 1, Abbas classification) or redo distal hypospadias (Grade 1, Abbas classification), with penile curvature less than 30° after degloving (measured as per Abbas, 2022), will be included. Exclusion criteria include previous hypospadias surgery, proximal hypospadias, penile curvature ≥30°, or syndromic anomalies/coagulopathies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Primary and complex distal hypospadias (Grade 1, Abbas classification)
- •Penile curvature <30° after degloving (Methodology of curvature measurement: Abbas T. O. (2022).
- •Children aged 6 months to 5 years
Exclusion Criteria
- •Previous hypospadias surgery
- •Proximal hypospadias
- •Penile curvature ≥30°
- •Syndromic anomalies or coagulopathy
Outcomes
Primary Outcomes
Hypospadias Cosmetic Score (HOSE)
Time Frame: Follow-up evaluations will occur at 1, 3, and 6 months postoperatively.
Assessment Method: Standardized digital photographs taken at 6 months postoperatively. Evaluators: Two independent pediatric urologists blinded to treatment allocation will evaluate the photographs. Measurement Tool: Cosmetic outcome scored using the Hypospadias Objective Scoring Evaluation (HOSE) system or a similar validated scale. Units: HOSE score (range 5-10). Higher scores: Indicate better cosmetic outcomes.
Hypospadias Cosmetic Score (HOSE)
Time Frame: Follow-up evaluations will occur at 1, 3, and 6 months postoperatively.
Assessment Method: Standardized digital photographs taken at 6 months postoperatively. Evaluators: Two independent pediatric urologists blinded to treatment allocation will evaluate the photographs. Measurement Tool: Cosmetic outcome scored using the Hypospadias Objective Scoring Evaluation (HOSE) system or a similar validated scale. Units: HOSE score (range 5-10). Higher scores: Indicate better cosmetic outcomes.
Secondary Outcomes
- Clinical examination for postoperative complications (fistula, stenosis, )(during follow-up visits at 1, 3, and 6 months post-surgery.)
- Clinical examination for postoperative complications (fistula, stenosis, )(during follow-up visits at 1, 3, and 6 months post-surgery.)
Investigators
Zafar Abdullaev
Head of Pediatric urology department at National Childrens' Medical Center, Tashkent, Uzbekistan
National Children's Medical Center, Uzbekistan