Reconstructing Forked Corpus Spongiosum in Hypospadias Repair

Fudan University

Status: Not yet enrolling

Conditions: Hypospadias

Treatments: Procedure: Reconstructing forked corpus spongiosum (FCS); Procedure: Routine standardized surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04533477

Zhangbin_001

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: Male

Ages: 6 months to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

260 participants in 2 patient groups

Routine surgery with reconstructing FCS

Experimental group

Description:

The participants undergo FCS reconstruction during the routine standardized surgery.

Treatment:

Procedure: Routine standardized surgery

Procedure: Reconstructing forked corpus spongiosum (FCS)

Routine surgery

Active Comparator group

Description:

The participants undergo routine standardized surgery.

Treatment:

Procedure: Routine standardized surgery