Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)
NCT ID: NCT06165120
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-11-01
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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group A; Bracka's repair group
This group will undergo Bracka's repair using preputial graft in treatment of proximal hypospadias with marked ventral curvature
Bracka's repair using preputial graft
Staged repair:
1. Correction of ventral chordee: by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test.
2. Preputial graft placement: a graft will be designed on the inner layer of the preputial hood, according to the length of the urethra defect. Fixation of the free graft will be performed along the whole defective urethral plate. A compression dressing will be used for the transplanted graft. At the end of the surgery, a urinary catheter will be placed through the ectopic meatus.
3. Tubularisation of the graft: this stage will be performed 6 months later. The new graft will be tubularised over a catheter. Then a protective layer may be made over the tubularization using a dartos or tunica vaginalis flap. After suturing of the penile skin and dressing of the penis, a urethral catheter would be retained for urinary diversion.
group B; STPIF repair group
This group will undergo STPIF repair using preputial flap in treatment of proximal hypospadias with marked ventral curvature
STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap
Staged repair:
1. Correction of ventral chordee; by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test.
2. Preputial flap placement: according to the distance between the ectopic meatus and the glans tip, a transverse rectangular flap will be dissected from the inner layer of the dorsal prepuce. The flap will be placed along the defective urethral plate. Eventually, a silicon indwelling catheter will be placed through the ectopic meatus.
3. Tubularisation of the flap: this stage procedure would be performed 6 months after the first procedure. Tubularisation of the the preputial flap will be done over a catheter. Byar's flaps may be created and transposed to cover the neourethra. Eventually, the penis will be dressed, and a urethral catheter will be retained for urinary diversion.
Interventions
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Bracka's repair using preputial graft
Staged repair:
1. Correction of ventral chordee: by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test.
2. Preputial graft placement: a graft will be designed on the inner layer of the preputial hood, according to the length of the urethra defect. Fixation of the free graft will be performed along the whole defective urethral plate. A compression dressing will be used for the transplanted graft. At the end of the surgery, a urinary catheter will be placed through the ectopic meatus.
3. Tubularisation of the graft: this stage will be performed 6 months later. The new graft will be tubularised over a catheter. Then a protective layer may be made over the tubularization using a dartos or tunica vaginalis flap. After suturing of the penile skin and dressing of the penis, a urethral catheter would be retained for urinary diversion.
STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap
Staged repair:
1. Correction of ventral chordee; by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test.
2. Preputial flap placement: according to the distance between the ectopic meatus and the glans tip, a transverse rectangular flap will be dissected from the inner layer of the dorsal prepuce. The flap will be placed along the defective urethral plate. Eventually, a silicon indwelling catheter will be placed through the ectopic meatus.
3. Tubularisation of the flap: this stage procedure would be performed 6 months after the first procedure. Tubularisation of the the preputial flap will be done over a catheter. Byar's flaps may be created and transposed to cover the neourethra. Eventually, the penis will be dressed, and a urethral catheter will be retained for urinary diversion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previously circumcised patients.
* Patients with complex urogenital malformations or DSD.
* Patients with ventral curvature less than 30 degrees.
* Patients with crippled hypospadias.
6 Months
18 Years
MALE
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Ahmed Mohamed Ahmed Mahmoud
Resident at Pediatric Surgery Departemt at Sohag University Hospitals
Locations
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Sohag University Hospitals
Sohag, , Egypt
Countries
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Central Contacts
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Ahmed M Abd El-Moniem Gafar, Professor
Role: CONTACT
Phone: 01005768450
Facility Contacts
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Ahmed M Mahmoud Abd Allah
Role: primary
Other Identifiers
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Soh-Med-23-10-013MS
Identifier Type: -
Identifier Source: org_study_id