Graft Versus Flap in Management of Proximal Penile Hypospadias

Not Applicable

Recruiting

• Conditions: Proximal Penile Hypospadias
• Interventions: Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias

• Registration Number: NCT06565286
• Lead Sponsor: Sohag University

Brief Summary

Proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. However, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the Holy Grail for hypospadias specialists.

Detailed Description

The surgical plan for proximal hypospadias can be divided into single and staged operations. Single stage operations are often associated with high rates of complications and reoperations. Reportedly, complications occur in 20-50% of patients. Therefore, many pediatric surgeons are selecting staged procedures. Staged surgical repair of proximal forms of hypospadias has been proven to achieve successful both functional and cosmetic results. Although staged repair with inner preputial layer graft has regained popularity in the repair of proximal hypospadias; but Choosing between flaps or grafts to substitute the urethral plate in 2-stage hypospadias repair has been a matter of debate with no consensus in the literature.

Flaps have reliable blood supply that may be theoretically less liable for strictures or contractures. Grafts are more versatile, which can be used in primary and recurrent cases when healthy local skin is deficient.

In this study, our aim is to compare outcomes of grafts and flaps when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias (penoscrotal and scrotal types).

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study Start: 2024-08-18
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Age: more than 6 months.
• Type of hypospadias: proximal penile hypospadias (scrotal and penoscrotal variants)

Exclusion Criteria

• Age: less than 6 months.
• Perineal hypospadias.
• circumcised patients.
• Previous hypospadias repair
• Raised serum creatinine, coagulopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inner preputial graft	inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias	managemet of proximal penile hypospadias in 2stage using inner preputial graft in the first stage
transverse preputial island flap	inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias	managemet of proximal penile hypospadias in 2stage using transverse preputial island flap in the first stage

Primary Outcome Measures

Name	Time	Method
measure complications after staged repair of proximal penile hypospadias using different techniques.	6 month after end of treatment	urinary fistulas, urethral strictures, diverticula and failed repair.

Trial Locations

Locations (1)

Sohag Faculty of Medicine; 🇪🇬 Sohag, Egypt