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Completed

NCT Number: NCT07592026

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

* 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.

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Key information

Conditions

Narrow Urethral Plate Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

6 month–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine for boys, Al-Azhar university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slit-like Adjusted Mathieu

Procedure

Slit-like Adjusted Mathieu

onlay island flap

Procedure

inner transverse preputial onlay island flap

Primary outcomes

  1. postoperative complications

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

Secondary outcomes

  1. Hypospadias Objective Scoring Evaluation score

    Time frame: at 12 months

    a validated 5-point system, ranging from 5 to 16

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics: A Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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