Hypospadias
Conditions
Keywords
hypospadias, edema, failure, fistula, steroids
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.
Interventions
DRUGsteroid betamethasone
The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
comparative prospective clinical trial
Eligibility
Sex/Gender
MALE
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Hypospadias Patient * Recurrent Cases * 6 months or more * Distal, and mid penile hypospadias
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure rate | 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of Tissue edema | 3 days, 5 days, 10 days, 2 weeks | — |
| Infection Rate | 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 |
Countries
Egypt
Outcome results
None listed