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
Launched by NATIONAL CHILDREN'S MEDICAL CENTER, UZBEKISTAN · Jun 30, 2025
Trial Information
Current as of July 05, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 conduct...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Primary and complex distal hypospadias (Grade 1, Abbas classification)
- • 2. Penile curvature \<30° after degloving (Methodology of curvature measurement: Abbas T. O. (2022).
- • 3. Children aged 6 months to 5 years
- Exclusion Criteria:
- • 1. Previous hypospadias surgery
- • 2. Proximal hypospadias
- • 3. Penile curvature ≥30°
- • 4. Syndromic anomalies or coagulopathy
About National Children's Medical Center, Uzbekistan
The National Children's Medical Center of Uzbekistan is a leading healthcare institution dedicated to the specialized medical care, research, and advancement of pediatric health. Committed to improving child health outcomes across the region, the center conducts clinical trials and innovative studies aimed at developing effective treatments and interventions for a wide range of pediatric conditions. Through its integration of clinical expertise and research excellence, the center plays a pivotal role in enhancing evidence-based pediatric healthcare in Uzbekistan.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tashkent, City, Uzbekistan
Patients applied
Trial Officials
Tariq Abbas, MD, PhD
Study Chair
Sidra Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported