Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics

NCT07592026 | Completed

• 1 other identifier: ped_Surg._102MedResearch._0102
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Narrow Urethral Plate Hypospadias

Keywords

Hypospadias; Slit-like Adjusted Mathieu; Onlay island flap; Urethroplasty; HOSE score

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  Follow-up was performed at 1, 3, 12, and 24 months to assess complications

Secondary Outcomes (1)

• Hypospadias Objective Scoring Evaluation score

  at 12 months

Study Arms (2)

SLAM repair

ACTIVE COMPARATOR

Slit-like Adjusted Mathieu

Procedure: Slit-like Adjusted Mathieu

onlay island flap

ACTIVE COMPARATOR

inner transverse preputial onlay island flap

Procedure: onlay island flap

Interventions

Slit-like Adjusted Mathieu PROCEDURE

Slit-like Adjusted Mathieu

SLAM repair

onlay island flap PROCEDURE

inner transverse preputial onlay island flap

onlay island flap

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• anterior or mid-penile hypospadias
• shallow and narrow urethral plate measuring \<6 mm,
• without or with mild penile curvature \<30° after degloving

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of medicine for boys, Al-Azhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pediatric surgery

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2020
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)