HypospadiasPhase 2NCT05253456
Modified Second Layer Repair for Distal Penile Hypospadias
A Phase 2 study testing Derma -Dartos Flap for second layer closure in people with Hypospadias, run by Ain Shams University at 1 site in Egypt.
Trial summary
to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias Read more about this study
- Who is it for?
- Ages 1 year to 18 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Derma -Dartos Flap for second layer closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 2 Sep 2020
- Phase
- Phase 2
- 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 1 year to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- All male patient with distal penile hypospadias aged less than 18
Who cannot join
- Patients with penile rotation or hypoplastic urethral plate were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Tubularized Incised Plate Urethroplasty (Snodgrass) For Distal Hypospadias Repair in a Circumcised Patient With the Use of a Derma -Dartos Flap for Second Layer Closure: Our Initial Experience
to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias
Read the detailed description
In our study, we applied a new modification by using an intervening layer of a de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly applied technique and its impact on the success rate.
- Conditions
- Hypospadias
- Being tested
- Derma -Dartos Flap for second layer closure
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Derma -Dartos Flap for second layer closureProcedure or surgery
usage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | patients underwent our newly modified technique for hypospadias repair Receives: Procedure: Derma -Dartos Flap for second layer closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
urethro-cutaneous fistula
presence of urethro-cutaneous fistula after closure of hypospadias as assess by inspection for the presence of urinary fistula
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Mar 2018
- Primary completion1 Sep 2020
- Study completion2 Sep 2020
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.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253456
- Sponsor's protocol ID
- R22/2018
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Tubularized Incised Plate Urethroplasty (Snodgrass) For Distal Hypospadias Repair in a Circumcised Patient With the Use of a Derma -Dartos Flap for Second Layer Closure: Our Initial Experience
- ClinicalTrials.gov ID
- NCT05253456
- Acronym / sponsor ID
- R22/2018
- Conditions
- Hypospadias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 23 Feb 2022 (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.
to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias
Detailed description
In our study, we applied a new modification by using an intervening layer of a de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly applied technique and its impact on the success rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: Derma -Dartos Flap for second layer closurepatients underwent our newly modified technique for hypospadias repair |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All male patient with distal penile hypospadias aged less than 18
Key exclusion criteria (1 listed)
- Patients with penile rotation or hypoplastic urethral plate were excluded from the study
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 |
|---|---|---|
| Derma -Dartos Flap for second layer closureusage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients | Procedure or surgery | intervention group |
Primary outcome
urethro-cutaneous fistula
Time frame: 1 year follow up
presence of urethro-cutaneous fistula after closure of hypospadias as assess by inspection for the presence of urinary fistula
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Derma -Dartos Flap for second layer closure in people with Hypospadias, run by Ain Shams 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 1 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: finished, as of the sponsor's last update on 23 Feb 2022. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
urethro-cutaneous fistula (time frame: 1 year follow up). 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 23 Feb 2022.