Reconstructing Forked Corpus Spongiosum in Hypospadias Repair
- Conditions
- Hypospadias
- Interventions
- Procedure: Routine standardized surgeryProcedure: Reconstructing forked corpus spongiosum (FCS)
- Registration Number
- NCT04533477
- Lead Sponsor
- Children's Hospital of Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 260
- children with primary hypospadias
- one-stage surgical repair
- staged surgery repair
- micropenis
- reoperation for postoperative complications
- using testosterone or male hormones preoperatively
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine surgery Routine standardized surgery The participants undergo routine standardized surgery. Routine surgery with reconstructing FCS Reconstructing forked corpus spongiosum (FCS) The participants undergo FCS reconstruction during the routine standardized surgery. Routine surgery with reconstructing FCS Routine standardized surgery The participants undergo FCS reconstruction during the routine standardized surgery.
- Primary Outcome Measures
Name Time Method Postoperative complications 1 to 6 months after surgery It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if any complications including residual chordee, fistula, diverticulum, glans dehiscence, meatus stenosis, or urethral stricture happeded.
- Secondary Outcome Measures
Name Time Method Residual chordee 1 to 6 months after surgery It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if residual chordee happeded.
Fistula 1 to 6 months after surgery It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if fistula happeded.
Diverticulum 1 to 6 months after surgery It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if diverticulum happeded.
Glans dehiscence 1 to 6 months after surgery It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if glans dehiscence happeded.
Meatus stenosis 1 to 6 months after surgery It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if meatus stenosis happeded.
Urethral stricture 1 to 6 months after surgery It is a binary variable (1/0) that needs repeated measurement. The variable would be setted into "1", if urethral stricture happeded.
Hypospadias objective scoring evaluation at 6 month after surgery It is an objective scoring system for evaluating the cosmetic outcome of hypospadias surgery. The scoring system is designed so that the minimum total score would be 5, corresponding to a worst score for each variable, to a maximum total of 16, equivalent to the best score for each variable.