Efficacy of Fibrin Sealant in Hypospadias Surgery
- Conditions
- Hypospadias
- Interventions
- Procedure: fibrin sealant in hypospadias
- Registration Number
- NCT05666206
- Lead Sponsor
- Al-Azhar University
- Brief Summary
The aim of the study was to evaluate if application of a fibrin sealant over the urethroplasty suture line for waterproofing instead of a dartos vascularized pedicled flap to reduce complications and improve the outcome in hypospadias repair.
- Detailed Description
Many procedures have been tried for the sake of proper management of hypospadias and reducing the complications. Of them, tabularized incised plate (TIP) is one of the most convenient technique, which became the most common procedure for hypospadias repair (Elsayem et al., 2022).
Although many surgical modifications and techniques have been prescribed to minimize post-operative complications and improve outcomes, a high percentage of complications still occurs. Urethrocutaneous fistulae are the most common post-operative complication (10%-40%) after hypospadias surgery; other complications being skin flap related complications such as flap necrosis, suture line breakdown, ascent of the testis and penile torsion (Shenoy et al.,2021).
In this thesis a secondary preputial dartos flap will be performed in all cases and we will evaluate the value of usage of fibrin glue on the 1ry suture line .
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 200
- Inclusion criteria All treatment naïve children with hypospadias.
- Adult hypospadias.
- Recurrent cases.
- Prio pelvic trauma or radiation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard TIP technique fibrin sealant in hypospadias standard TIP technique with second dartos flap and no use of fibrin sealant Fibrin group fibrin sealant in hypospadias Fibrin sealant covered with 2ry dartos flap.
- Primary Outcome Measures
Name Time Method Success of surgery 3 months Number of patients with good stream, normal looking meatus and no need for auxiliary maneuvers.
- Secondary Outcome Measures
Name Time Method complications of hypospadias surgery 3 months Number of patients with fistula, chordee, rotation, ....
Trial Locations
- Locations (1)
Urology department - AlAzhar university
🇪🇬Cairo, Egypt