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

Hypospadias Clinical Trial

Official title:

Prospective Comparative Trial to Assess the Role of Local Long Acting Steroid Injection After Hypospadias Surgery in Decreasing Complications and Preserving Better Cosmesis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04196400
• Other study ID #: Hypospadias-101
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: December 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: March 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• Hypospadias Patient

• Recurrent Cases

• 6 months or more

• Distal, and mid penile hypospadias

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Hypospadias

Intervention

Drug:
• steroid betamethasone
The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair

Locations

Country	Name	City	State
Egypt	Cairo Univeristy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rate		2 weeks
Secondary	incidence of Tissue edema		3 days, 5 days, 10 days, 2 weeks
Secondary	Infection Rate		3 days, 5 days, 10 days, 2 weeks
Secondary	Fistula rate		2 weeks
Secondary	Final cosmesis	The shape of the glans penis and surrounding tissue	3 days, 5 days, 10 days, 2 weeks