Loading clinical trials...
Loading clinical trials...
Urethral Plate Flap Versus Tunica Vaginalis Flap Corporoplasty for the Correction of Residual Severe Ventral Curvature After Urethral Plate Transection in Hypospadias Repair: A Single-Center, Randomized, Controlled, Non-Inferiority Study
The correction of ventral curvature in hypospadias follows a stepwise principle. Clinically, in some cases of hypospadias, residual severe ventral curvature (VC ≥ 30°) persists even after thorough skin degloving and transection of the urethral plate, due to the unbalanced development of the ventral and dorsal tunica albuginea of the corpus cavernosum. In such cases, ventral tunica albuginea incision and corporoplasty with a graft are mandatory. Although the currently commonly used pedicled Tunica Vaginalis Flap (TVF) corporoplasty can effectively correct the curvature, it requires additional dissection of the scrotum and tunica vaginalis sac. This prolongs the operative time and poses risks of donor-site complications, such as testicular retraction and scrotal hematoma. The novel Urethral Plate Flap (UPF) corporoplasty utilizes local pedicled urethral plate tissue for homologous repair. This study adopts a prospective, single-center, randomized, controlled, double-blind, non-inferiority trial design, enrolling 90 subjects. The aim is to verify that the therapeutic efficacy of the UPF technique in correcting such residual severe ventral curvature is non-inferior to that of TVF, while demonstrating significant advantages in surgical efficiency and donor-site safety. This study aims, through a single-center, double-blind, RCT design, and under the strict indication of "residual severe ventral curvature after urethral plate transection," to verify efficacy via a "non-inferiority" hypothesis, and to verify safety and efficiency via a "superiority" hypothesis. The goal is to provide Level I evidence for the update of hypospadias guidelines, while simultaneously exploring the establishment of postoperative imaging evaluation standards.
Age
0 - 14 years
Sex
MALE
Healthy Volunteers
No
Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Start Date
February 23, 2026
Primary Completion Date
November 30, 2027
Completion Date
February 22, 2029
Last Updated
February 11, 2026
90
ESTIMATED participants
Urethral Plate Flap Corporoplasty
PROCEDURE
Tunica Vaginalis Flap Corporoplasty
PROCEDURE
Lead Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions