- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196400
The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.
Prospective Comparative Trial to Assess the Role of Local Long Acting Steroid Injection After Hypospadias Surgery in Decreasing Complications and Preserving Better Cosmesis
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 002
- Cairo Univeristy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hypospadias Patient
- Recurrent Cases
- 6 months or more
- Distal, and mid penile hypospadias
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control Group
|
|
ACTIVE_COMPARATOR: Steroid injection
Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.
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The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Failure rate
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of Tissue edema
Time Frame: 3 days, 5 days, 10 days, 2 weeks
|
3 days, 5 days, 10 days, 2 weeks
|
|
Infection Rate
Time Frame: 3 days, 5 days, 10 days, 2 weeks
|
3 days, 5 days, 10 days, 2 weeks
|
|
Fistula rate
Time Frame: 2 weeks
|
2 weeks
|
|
Final cosmesis
Time Frame: 3 days, 5 days, 10 days, 2 weeks
|
The shape of the glans penis and surrounding tissue
|
3 days, 5 days, 10 days, 2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypospadias-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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