Clinical trial NCT06165120: Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)
Official title: Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypospadias, Penoscrotal
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 20
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All patients with proximal hypospadias with marked ventral curvature (\>30 degrees) who presented to the outpatient clinic of Department of Pediatric Surgery in Sohag University Hospital.

Exclusion Criteria:

* Patients with insufficient follow up data or those who are non-compliant on follow up.
* Previously circumcised patients.
* Patients with complex urogenital malformations or DSD.
* Patients with ventral curvature less than 30 degrees.
* Patients with crippled hypospadias.

Primary outcomes:
measure: Incidence of residual ventral curvature
timeFrame: 1 year
measure: Incidence of meatal stenosis
timeFrame: 1 year
measure: Incidence of urethral stricture
timeFrame: 1 year
measure: Incidence of glans dehiscence
timeFrame: 1 year
measure: Incidence of urethro-cutaneous fistula
timeFrame: 1 year
measure: Incidence of urethral diverticula formation
timeFrame: 1 year
measure: Incidence of graft/flap fibrosis after the first stage
timeFrame: 1 year
measure: Percentage of patients with accepted cosmetic appearance
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospitals
Study officials:
References: