Graft Versus Flap in Management of Proximal Penile Hypospadias

Sohag University

Status: Enrolling

Conditions: Proximal Penile Hypospadias

Treatments: Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias

Study type: Interventional

Funder types: Other

Identifiers

NCT06565286

Soh-Med-24-06-02MD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: Male

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

inner preputial graft

Active Comparator group

Description:

managemet of proximal penile hypospadias in 2stage using inner preputial graft in the first stage

Treatment:

Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias

transverse preputial island flap

Active Comparator group

Description:

managemet of proximal penile hypospadias in 2stage using transverse preputial island flap in the first stage

Treatment:

Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias