Dorsal inlay graft plus TIP versus TIP alone for primary hypospadias repair
Official title: Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias? A Randomized Clinical Trial
Run by Al-Azhar University · NCT07086963 · Data updated 2026-11-12
This trial tests whether adding a dorsal inlay preputial graft to the standard TIP repair helps uncircumcised boys having one-stage primary hypospadias surgery without chordee get a better urinary opening position, shape, and fewer complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 120 Months |
| Sex | Men only |
| Enrollment | 584 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | January 2, 2023 |
| Main results expected | July 25, 2025 |
| Study ends | August 8, 2025 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT07086963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are uncircumcised boys in the pediatric age range with primary hypospadias suitable for a one-stage repair, no chordee, glans size ≥11 mm, and willingness to attend regular follow-up.
✕Probably not a fit
Patients with chordee, urethral anomalies requiring urethral plate division or staged repair, glanular hypospadias, very small glans (<11 mm), or those already circumcised are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized comparison of two surgical techniques for primary hypospadias without chordee: standard Tabularized Incised Plate (TIP) repair versus TIP augmented with a dorsal inlay preputial graft (GIP). Uncircumcised pediatric patients suitable for one-stage repair were randomized by sealed envelope and operated on by the participating surgical team. Outcomes included meatal position and shape, neourethral function, fistula formation, wound complications, cosmetic results, need for reoperation, and HOSE scoring at six months. Follow-up included early wound checks, catheter removal at two weeks, calibration after catheter removal, monthly visits for six months, and HOSE scoring at six months.
Why it matters
Potential benefit: If successful, the grafted inlay plus TIP could improve meatal position and shape, reduce urethrocutaneous fistulas, and lower the need for repeat surgery.
How similar studies have gone: Similar graft-augmented TIP techniques have been reported previously with promising results in selected patients with narrow plates, but published outcomes are mixed and not uniformly superior to standard TIP.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary hypospadias candidates for one-stage repair * Uncircumcised cases * Pediatric age group * Patients with regular follow up Exclusion Criteria: * The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair * Small glans \< 11mm * glanular hypospadias
Where it's running
-
Mohammad Daboos
Cairo, Egypt Recruiting
Study contacts
- Principal investigator: Mohammad Daboos — Al-Azhar University
- Study coordinator: Mohammad Daboos, Prof
- Email: daboosmohammad@gmail.com
- Phone: 01007578148
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.