Reconstructing Forked Corpus Spongiosum in Hypospadias Repair

NCT ID: NCT04533477

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-09-30

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.

Conditions

Hypospadias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Routine surgery with reconstructing FCS

The participants undergo FCS reconstruction during the routine standardized surgery.

Group Type: EXPERIMENTAL

Reconstructing forked corpus spongiosum (FCS)

Intervention Type: PROCEDURE

During the routine standardized surgery, the FCS should be cut off along both sides of the middle urethral plate before dissecting the glans wings and then dissected along the penile tunica albuginea closely from the near to the far side of the penis until the top of the penis head was reached. The corpus spongiosum on both sides will be reserved for the two wings of the glans. The two wings of the glans should be carefully expanded to at least the 3 o'clock and 9 o'clock positions of the penis. Some cases of small glans should be dissected to the 2 o'clock and 10 o'clock positions to close the two wings of the glans with no tension when performing glansplasty. Additionally, the original FCS on both sides should be combined at the coronal sulcus, thereby covering the surface of the new urethra.

Routine standardized surgery

Intervention Type: PROCEDURE

When the urethral plate can be preserved after degloving, the investigators chose the surgical method according to the width of the urethral plate. If the width of the urethral plate is ≥6 mm, tubularized incised plate (TIP) urethroplasty will be performed, whereas if the width of the urethral plate is \<6 mm, the onlay island flap (ONLAY) technique will be performed. When the urethral plate can not be preserved after degloving, transverse preputial island flap urethroplasty (Duckett) will be performed.

Routine surgery

The participants undergo routine standardized surgery.

Group Type: ACTIVE_COMPARATOR

Routine standardized surgery

Intervention Type: PROCEDURE

When the urethral plate can be preserved after degloving, the investigators chose the surgical method according to the width of the urethral plate. If the width of the urethral plate is ≥6 mm, tubularized incised plate (TIP) urethroplasty will be performed, whereas if the width of the urethral plate is \<6 mm, the onlay island flap (ONLAY) technique will be performed. When the urethral plate can not be preserved after degloving, transverse preputial island flap urethroplasty (Duckett) will be performed.

Interventions

Reconstructing forked corpus spongiosum (FCS)

During the routine standardized surgery, the FCS should be cut off along both sides of the middle urethral plate before dissecting the glans wings and then dissected along the penile tunica albuginea closely from the near to the far side of the penis until the top of the penis head was reached. The corpus spongiosum on both sides will be reserved for the two wings of the glans. The two wings of the glans should be carefully expanded to at least the 3 o'clock and 9 o'clock positions of the penis. Some cases of small glans should be dissected to the 2 o'clock and 10 o'clock positions to close the two wings of the glans with no tension when performing glansplasty. Additionally, the original FCS on both sides should be combined at the coronal sulcus, thereby covering the surface of the new urethra.

Intervention Type: PROCEDURE

Routine standardized surgery

When the urethral plate can be preserved after degloving, the investigators chose the surgical method according to the width of the urethral plate. If the width of the urethral plate is ≥6 mm, tubularized incised plate (TIP) urethroplasty will be performed, whereas if the width of the urethral plate is \<6 mm, the onlay island flap (ONLAY) technique will be performed. When the urethral plate can not be preserved after degloving, transverse preputial island flap urethroplasty (Duckett) will be performed.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhangbin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Zhangbin_001

Identifier Type: -

Identifier Source: org_study_id