Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565286
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Graft Versus Flap in Management of Proximal Penile Hypospadias
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Inlay Inner Preputial Graft Versus Transverse Preputial Island Flap in Management of Proximal Penile Hypospadias
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None