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Hypospadias is a male congenital anomaly characterized by the abnormally located urethral meatus being displaced along the ventral side of the penis along a line from the tip of glans penis to the perineum.
Hypospadias is one of the most common congenital malformations of the male genitourinary system, with a reported global incidence of 0.6-34.2 per 10,000 live births. There is more than one classification for hypospadias. Most commonly, hypospadias is classified into proximal & distal hypospadias which mainly affects the decision for the corrective procedure.
Correction of proximal hypospadias remains a surgical challenge, which is mainly due to the pathological features of proximal hypospadias including a more proximal meatus, severe ventral chordee, and the need to transect the urethral plate during the operation.
The use of a 2-stage repair was found to achieve more satisfactory functional and cosmetic outcomes for proximal hypospadias with severe ventral chordee . Bracka repair, first described in 1995 by Bracka, is a 2-stage repair which uses grafts. This procedure has been improved over time, and recently it has been associated with satisfactory outcomes in proximal hypospadias with severe ventral curvature. Staged transverse preputial island flap urethroplasty (STPIF), first reported by Chen et al., is another 2-stage repair using flaps based on the traditional transverse preputial island flap (TPIF). STPIF has been shown to reduce the difficulty of surgery and the complication rate in management of proximal hypospadias. Thus, both Bracka repair and STPIF are valuable 2-stage methods, and both have achieved promising results. However, there are no available clear comparative data for determination which method has a better outcome and less complications in treating proximal hypospadias.
This study compares Bracka's procedure using preputial grafts and STPIF (Staged Preutial Island Flap) procedure using preputial flaps in surgical correction of proximal hypospadias with marked ventral curvtaure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A; Bracka's repair group | Active Comparator | This group will undergo Bracka's repair using preputial graft in treatment of proximal hypospadias with marked ventral curvature |
|
| group B; STPIF repair group | Active Comparator | This group will undergo STPIF repair using preputial flap in treatment of proximal hypospadias with marked ventral curvature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bracka's repair using preputial graft | Procedure | Staged repair:
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of residual ventral curvature | measured in degrees; if less than 15 degrees it's acceptable, if more than 15 degrees it will need further correction | 1 year |
| Incidence of meatal stenosis | calibrated by urethral Hegar's dilators according to the age | 1 year |
| Incidence of urethral stricture | calibrated by urethral Hegar's dilators according to the age | 1 year |
| Incidence of glans dehiscence | evaluated subjectively by the patients or the parents using questionnaires and objectively by the surgeons | 1 year |
| Incidence of urethro-cutaneous fistula | measured in millimeters; if less than 3 millimeters it's a micro-fistula, if it's more than 3 millimeters it's a macro-fistula | 1 year |
| Incidence of urethral diverticula formation | evaluated by voiding problems | 1 year |
| Incidence of graft/flap fibrosis after the first stage | evaluated objectively by signs of inflammation, necrosis and fibrosis | 1 year |
| Percentage of patients with accepted cosmetic appearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Mahmoud Abd Allah, Resident | Contact | 01144345755 | ahmedmahmoud@med.sohag.edu.eg | |
| Ahmed M Abd El-Moniem Gafar, Professor | Contact | 01005768450 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University Hospitals | Recruiting | Sohag | 82511 | Egypt |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 12, 2025 | |
| Reset | Mar 5, 2025 |
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|
| STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap | Procedure | Staged repair:
|
|
assessed by questionnaires obtained from the patients and/or the parents
| 1 year |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 12, 2025 | Mar 5, 2025 |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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