Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypospadias, Penoscrotal
• Intervention / Treatment: Procedure: Bracka's repair using preputial graft; Procedure: STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Mahmoud Abd Allah, Resident; Phone Number: 01144345755; Email: ahmedmahmoud@med.sohag.edu.eg
• Study Contact Backup: Name: Ahmed M Abd El-Moniem Gafar, Professor; Phone Number: 01005768450

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Recruiting
    • Sohag University Hospitals
    • Contact: Ahmed M Mahmoud Abd Allah; Phone Number: 01144345755; Email: ahmedmahmoud@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Bracka's repair using preputial graft; Staged repair: 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.; 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.; 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.
Active Comparator: group B; STPIF repair group; This group will undergo STPIF repair using preputial flap in treatment of proximal hypospadias with marked ventral curvature	Procedure: STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap; Staged repair: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	assessed by questionnaires obtained from the patients and/or the parents	1 year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias
• Other Study ID Numbers: Soh-Med-23-10-013MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No