Skip to content

Graft Versus Flap in Management of Proximal Penile Hypospadias

Inlay Inner Preputial Graft Versus Transverse Preputial Island Flap in Management of Proximal Penile Hypospadias

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06565286
Enrollment
50
Registered
2024-08-21
Start date
2024-08-18
Completion date
2026-08-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Penile Hypospadias

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).

Interventions

PROCEDUREinner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias

compare outcomes of inner preputial graft versus transverse preputial island flap when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias .

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Inlay inner preputial graft versus Transverse preputial island flap in management of proximal penile hypospadias

Eligibility

Sex/Gender
MALE
Age
6 Months to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
measure complications after staged repair of proximal penile hypospadias using different techniques.6 month after end of treatmenturinary fistulas, urethral strictures, diverticula and failed repair.

Countries

Egypt

Contacts

Primary Contactahmed abohammady, denominator
ahmedshaban71992@gmail.com01016631447
Backup Contacthazem elmoghazy, professor
moghazyh@yahoo.com01096522289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026