HypospadiasEarly Phase 1NCT04196400
The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.
A Early Phase 1 study testing steroid betamethasone in people with Hypospadias, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 months and older, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- steroid betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hypospadias Patient
- Recurrent Cases
- 6 months or more
- Distal, and mid penile hypospadias
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hypospadias
- Being tested
- steroid betamethasone
- Keywords
- hypospadias, edema, failure, fistula, steroids
- Medical subject headings
- Hypospadias, Edema, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid betamethasoneDrug
The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair
| Study group | Role | What they receive |
|---|---|---|
| Steroid injection | Active comparator | Steroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site. Receives: Drug: steroid betamethasone |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
Measured: 2 weeks
Secondary outcomes (4)
incidence of Tissue edema
Measured: 3 days, 5 days, 10 days, 2 weeks
Infection Rate
Measured: 3 days, 5 days, 10 days, 2 weeks
Fistula rate
Measured: 2 weeks
Final cosmesis
The shape of the glans penis and surrounding tissue
Measured: 3 days, 5 days, 10 days, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative prospective clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abozamel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196400
- Sponsor's protocol ID
- Hypospadias-101
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04196400
- Acronym / sponsor ID
- Hypospadias-101
- Conditions
- Hypospadias
- Keywords
- hypospadias, edema, failure, fistula, steroids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- comparative prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| Steroid injection | Active comparator | Drug: steroid betamethasoneSteroid (betamethasone) 2 ml is injected subcutaneously after finishing the operation at the repair site. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 6 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Hypospadias Patient
- Recurrent Cases
- 6 months or more
- Distal, and mid penile hypospadias
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroid betamethasoneThe steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair | Drug | Steroid injection |
Primary outcome
Failure rate
Time frame: 2 weeks
4 secondary outcomes
incidence of Tissue edema
Time frame: 3 days, 5 days, 10 days, 2 weeks
Infection Rate
Time frame: 3 days, 5 days, 10 days, 2 weeks
Fistula rate
Time frame: 2 weeks
Final cosmesis
Time frame: 3 days, 5 days, 10 days, 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing steroid betamethasone in people with Hypospadias, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure rate (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.