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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Recurrence Rate of Ventral Curvature at 12 Months Postoperatively
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 6 months to 14 years.
- •Diagnosis: Primary hypospadias (no history of prior hypospadias repair).
- •Intraoperative Condition: Residual ventral curvature ≥ 30° confirmed by artificial erection test after transection of the urethral plate.
- •Consent: Signed informed consent provided by the participant's legal guardian.
排除标准
- •① Glans diameter < 1 cm; ② Combined with cryptorchidism; ③ Combined with severe bleeding disorders or coagulation dysfunction.
研究组 & 干预措施
Urethral Plate Flap Corporoplasty
- After degloving and transecting the urethral plate, mobilize the urethral plate.
- Transect the tunica albuginea at the point of maximal curvature to fully correct the ventral curvature.
- Mobilize and open the tunica vaginalis sac, and harvest a pedicled Tunica Vaginalis Flap (TVF).
- Transfer the TVF to the ventral side to repair the tunica albuginea defect, and suture with 6-0 absorbable sutures.
- Mobilize the space between the scrotal skin and dartos fascia. Place 2 interrupted sutures between the external spermatic fascia near the testis and the dartos fascia at the scrotal base to fix the testis within the sub-dartos space.
干预措施: Urethral Plate Flap Corporoplasty (Procedure)
Tunica Vaginalis Flap Corporoplasty
- After degloving and transecting the urethral plate, mobilize the urethral plate.
- Transect the tunica albuginea at the point of maximal curvature to fully correct the ventral curvature.
- Mobilize and open the tunica vaginalis sac, and harvest a pedicled Tunica Vaginalis Flap (TVF).
- Transfer the TVF to the ventral side to repair the tunica albuginea defect, and suture with 6-0 absorbable sutures.
- Mobilize the space between the scrotal skin and dartos fascia. Place 2 interrupted sutures between the external spermatic fascia near the testis and the dartos fascia at the scrotal base to fix the testis within the sub-dartos space.
干预措施: Tunica Vaginalis Flap Corporoplasty (Procedure)
结局指标
主要结局
Recurrence Rate of Ventral Curvature at 12 Months Postoperatively
时间窗: 12 Months Postoperatively
Recurrence of ventral curvature is defined as residual ventral curvature ≥ 10° on lateral photographs during artificial erection.
次要结局
- Operative Time for Curvature Correction(Intraoperative)
- Incidence of Donor-Site Complications(From enrollment to the end of treatment at 12 months)
- Continuity of the tunica albuginea(12 months postoperatively)
- Echogenicity of the corpus cavernosum beneath the graft(12 month postoperatively)
研究者
Wei Ru
Associate Chief Physician
The Children's Hospital of Zhejiang University School of Medicine