The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.
- Registration Number
- NCT04196400
- Lead Sponsor
- Cairo University
- Brief Summary
Post-operative tissue oedema is one of the main causes of failure of hypospadias repair. Severe oedema may disrupt the suture line, invite infection and result in repair failure. Thus, we suggested that local injection of corticosteroids in just below coronal sulcus into dartos and buck's fascia may limit this oedema thus improving the outcome of hypospadias repair.
- Detailed Description
This is a prospective comparative trial : comparing the use of local steroids injection to reduce tissue edema after hypospadias and to preserve the final cosmesis after tissue repair.
The patients will be divided into 2 groups(each group 20 patients): one group will be injected steroids just after hypospadias surgery while the other will not.
The short and long term outcomes between both groups will be compared.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 40
- Hypospadias Patient
- Recurrent Cases
- 6 months or more
- Distal, and mid penile hypospadias
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Steroid injection steroid betamethasone Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.
- Primary Outcome Measures
Name Time Method Failure rate 2 weeks
- Secondary Outcome Measures
Name Time Method incidence of Tissue edema 3 days, 5 days, 10 days, 2 weeks Fistula rate 2 weeks Final cosmesis 3 days, 5 days, 10 days, 2 weeks The shape of the glans penis and surrounding tissue
Infection Rate 3 days, 5 days, 10 days, 2 weeks
Trial Locations
- Locations (1)
Cairo Univeristy Hospital
🇪🇬Cairo, Egypt