Back to resultsThe Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.
Primary Purpose
Hypospadias
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
steroid betamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Hypospadias focused on measuring hypospadias, edema, failure, fistula, steroids
Eligibility Criteria
Inclusion Criteria:
- Hypospadias Patient
- Recurrent Cases
- 6 months or more
- Distal, and mid penile hypospadias
Exclusion Criteria:
- None
Sites / Locations
- Cairo Univeristy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Steroid injection
Control Group
Arm Description
Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.
Outcomes
Primary Outcome Measures
Failure rate
Secondary Outcome Measures
incidence of Tissue edema
Infection Rate
Fistula rate
Final cosmesis
The shape of the glans penis and surrounding tissue
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04196400
Brief Title
The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias
Keywords
hypospadias, edema, failure, fistula, steroids
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
comparative prospective clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Steroid injection
Arm Type
Active Comparator
Arm Description
Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
steroid betamethasone
Intervention Description
The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair
Primary Outcome Measure Information:
Title
Failure rate
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
incidence of Tissue edema
Time Frame
3 days, 5 days, 10 days, 2 weeks
Title
Infection Rate
Time Frame
3 days, 5 days, 10 days, 2 weeks
Title
Fistula rate
Time Frame
2 weeks
Title
Final cosmesis
Description
The shape of the glans penis and surrounding tissue
Time Frame
3 days, 5 days, 10 days, 2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypospadias Patient
Recurrent Cases
6 months or more
Distal, and mid penile hypospadias
Exclusion Criteria:
None
Facility Information:
Facility Name
Cairo Univeristy Hospital
City
Cairo
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
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The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.
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