Clinical trial NCT04533477: Reconstructing Forked Corpus Spongiosum in Hypospadias Repair
Official title: Application and Efficacy of Reconstructing Forked Corpus Spongiosum in Hypospadias Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypospadias
Keywords: Hypospadias repair
Forked corpus spongiosum
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 260
Sex: MALE
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypospadias is one of the most common genital malformations in children. The high incidence of hypospadias, which occurs in 1 in 200 to 300 live births, means that it affects a large number of patients. Surgery is the only way to repair hypospadias. Over 400 techniques have been described for hypospadias repair. However, the surgical success rate of hypospadias is still not ideal. Although the surgical success rate of distal hypospadias has reached more than 85%, the complications of proximal hypospadias are still as high as 30-68%. How to improve surgical skills and reduce the postoperative complications is quite a challenge for pediatric urologists.

In the preliminary clinical work, the investigators have tried to apply the technique of reconstructing forked corpus spongiosum (FCS) in hypospadias repair with urethral plate preservation. It has been confirmed that this technique was effective in reducing postoperative complications of this type of hypospadias repair. In order to promote the technology of reconstructing FCS, the investigators need to perform this technology in various types of hypospadias and evaluate its true effectiveness. Therefore, the investigators need to design a prospective, randomized, parallel-controlled, single-blind, and superior clinical trial to analyze the efficacy of reconstructing FCS in hypospadias repair.

In this study, the investigators will perform one-stage surgical repair on children with primary hypospadias by the same surgeon in Urology Department, Children's Hospital of Fudan University, Shanghai, China. Participants will be random grouped: Routine standardized surgery with reconstructing FCS group and Routine standardized surgery group. All participants will be closely followed up and regularly evaluated after surgery, including postoperative complications, HOSE objective score of cosmetic outcome and voiding function. By collecting all data and conducting statistical analysis, the investigators will evaluate the followings: (1) the correlation between the penile curvature and the development of FCS; (2) the effect of reconstructing FCS on the complications of primary hypospadias repair; (3) the effect of reconstructing FCS on the cosmetic outcome; (4) the influence of reconstructing FCS on postoperative voiding function.

Based on this clinical randomized controlled study, the investigators intend to prove the feasibility and effectiveness of the new technology of reconstructing FCS in various types of hypospadias repair. The study will provide a reliable basis for the promotion of this technology for hypospadias repair in order to improve the quality of life for children with hypospadias.


Eligibility criteria: Inclusion Criteria:

* children with primary hypospadias
* one-stage surgical repair

Exclusion Criteria:

* staged surgery repair
* micropenis
* reoperation for postoperative complications
* using testosterone or male hormones preoperatively

Primary outcomes:
measure: Postoperative complications
timeFrame: 1 to 6 months after surgery
Secondary outcomes:
measure: Residual chordee
timeFrame: 1 to 6 months after surgery
measure: Fistula
timeFrame: 1 to 6 months after surgery
measure: Diverticulum
timeFrame: 1 to 6 months after surgery
measure: Glans dehiscence
timeFrame: 1 to 6 months after surgery
measure: Meatus stenosis
timeFrame: 1 to 6 months after surgery
measure: Urethral stricture
timeFrame: 1 to 6 months after surgery
measure: Hypospadias objective scoring evaluation
timeFrame: at 6 month after surgery
Other outcomes:
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