Using fibrin sealant to improve hypospadias surgery outcomes
Efficacy of Fibrin Sealant in Hypospadias Surgery
This study is testing if using a special sealant during surgery for hypospadias can help reduce complications and improve recovery for young boys undergoing this procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | Male |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05666206 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of applying a fibrin sealant over the urethroplasty suture line during hypospadias repair to reduce complications and enhance surgical outcomes. The research focuses on the tabularized incised plate (TIP) technique, which is commonly used for hypospadias repair. By comparing the fibrin sealant approach to traditional methods, the study aims to address the high incidence of post-operative complications such as urethrocutaneous fistulae and skin flap issues. The study will include treatment-naïve children with hypospadias and will exclude adults and recurrent cases.
Who should consider this trial
Good fit: Ideal candidates for this study are treatment-naïve children diagnosed with hypospadias.
Not a fit: Patients who are adults, have recurrent hypospadias, or have a history of pelvic trauma or radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative complications in children undergoing hypospadias repair.
How similar studies have performed: While there have been various surgical techniques for hypospadias repair, the specific use of fibrin sealant in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria All treatment naïve children with hypospadias. Exclusion Criteria: * Adult hypospadias. * Recurrent cases. * Prio pelvic trauma or radiation.
Where this trial is running
Cairo
- Urology department - AlAzhar university — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed F Salman, MD
- Email: Prof_mohamed_fawzy@yahoo.com
- Phone: +201111788996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.