Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pedia… (NCT07592026) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Slit-like Adjusted Mathieu Versus Onlay Island Flap for Hypospadias Repair in Pediatrics
Egypt80 participantsStarted 2020-05-01
Plain-language 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.
Who can participate
Age range
6 Months – 12 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
postoperative complications
Timeframe: Follow-up was performed at 1, 3, 12, and 24 months to assess complications