Clinical trial NCT06565286: Graft Versus Flap in Management of Proximal Penile Hypospadias
Official title: Inlay Inner Preputial Graft Versus Transverse Preputial Island Flap in Management of Proximal Penile Hypospadias
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proximal Penile Hypospadias
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 50
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Inlay inner preputial graft versus Transverse preputial island flap in management of proximal penile hypospadias
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: measure complications after staged repair of proximal penile hypospadias using different techniques.
timeFrame: 6 month after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag University
name: mohamed diaa, professor
role: STUDY_DIRECTOR
References:
citation: Kojima Y, Kohri K, Hayashi Y. Genetic pathway of external genitalia formation and molecular etiology of hypospadias. J Pediatr Urol. 2010 Aug;6(4):346-54. doi: 10.1016/j.jpurol.2009.11.007. Epub 2009 Dec 7.
citation: Bouty A, Ayers KL, Pask A, Heloury Y, Sinclair AH. The Genetic and Environmental Factors Underlying Hypospadias. Sex Dev. 2015;9(5):239-259. doi: 10.1159/000441988. Epub 2015 Nov 28.
citation: Hsieh MH, Breyer BN, Eisenberg ML, Baskin LS. Associations among hypospadias, cryptorchidism, anogenital distance, and endocrine disruption. Curr Urol Rep. 2008 Mar;9(2):137-42. doi: 10.1007/s11934-008-0025-0.