NCT07592026CompletedNot Applicable
Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 80
- Locations
- 1
Study Overview
Brief Summary
- Purpose** To compare the Slit-like Adjusted Mathieu (SLAM) technique versus the inner transverse preputial onlay island flap for repair of anterior and mid-penile hypospadias with narrow urethral plate, evaluating complication rates, surgical outcomes, and cosmetic results.
- Methods** This prospective randomized controlled study included 80 patients with anterior and mid-penile hypospadias with a urethral plate <6 mm, conducted at Al-Azhar University Hospitals, Cairo, Egypt, from May 2020 to October 2025. Patients were randomly allocated to SLAM repair (Group A, n=40) or inner transverse preputial onlay island flap (Group B, n=40). Follow-up ranged from 24 to 48 months. Outcomes were assessed using the Hypospadias Objective Scoring Evaluation (HOSE) questionnaire.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 12 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •anterior or mid-penile hypospadias
- •shallow and narrow urethral plate measuring <6 mm,
- •without or with mild penile curvature <30° after degloving
Exclusion Criteria
- •wide urethral plate suitable for Tubularized Incised Plate (TIP) urethroplasty,
- •other types of hypospadias (penoscrotal, scrotal, or perineal),
- •moderate or severe penile curvature (>30°)
- •recurrent cases
Investigators
Mohamed Abdelmaboud
Associate professor of pediatric surgery
Al-Azhar University
Study Sites (1)
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