The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.

Cairo University (CU)

Status and phase: Unknown; Early Phase 1

Conditions: Hypospadias

Treatments: Drug: steroid betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04196400

Hypospadias-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypospadias Patient
• Recurrent Cases
• 6 months or more
• Distal, and mid penile hypospadias

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Steroid injection

Active Comparator group

Description:

Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.

Treatment:

Drug: steroid betamethasone

Control Group

No Intervention group