Pediatric DisorderNCT05123833
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
A study testing Hypospadias repair in people with Pediatric Disorder and Hypospadias, run by Mansoura University at 1 site in Egypt.
Trial summary
To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap. Read more about this study
- Who is it for?
- Ages 6 months to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pediatric Disorder, Hypospadias, Congenital Hypospadia
- What is being tested?
- Hypospadias repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Aug 2022
- Phase
- Interventional
- 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 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 6 months.
- Distal, mid-shaft penile hypospadias.
Who cannot join
- Glanular hypospadias.
- Penoscrotal, Scrotal \& Perineal hypospadias.
- Recurrent cases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.
- Being tested
- Hypospadias repair
- Keywords
- Hypospadias repair, Tunica Vaginalis Flap, Dartos Fascia, Fistula
- Medical subject headings
- Hypospadias, Urologic Diseases, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypospadias repairProcedure or surgery
surgical repair of hypospadias
| Study group | Role | What they receive |
|---|---|---|
| Dartos Fascia | Active comparator | Dartos flap is used as a covering layer for urethra during repair of hypospadias Receives: Procedure: Hypospadias repair |
| Tunica Vaginalis | Active comparator | Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias Receives: Procedure: Hypospadias repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula
Fistula prevalence will be recorded as a complication after surgery
Measured: Within the first three months after surgery.
Secondary outcomes (1)
Cosmetic outcome
Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS).
Measured: Within the first three months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123833
- Sponsor's protocol ID
- Hypospadias-UC
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- 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 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05123833
- Acronym / sponsor ID
- Hypospadias-UC
- Keywords
- Hypospadias repair, Tunica Vaginalis Flap, Dartos Fascia, Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 17 Nov 2021 (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 explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dartos Fascia | Active comparator | Procedure: Hypospadias repairDartos flap is used as a covering layer for urethra during repair of hypospadias |
| Tunica Vaginalis | Active comparator | Procedure: Hypospadias repairTunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age ≥ 6 months.
- Distal, mid-shaft penile hypospadias.
Key exclusion criteria (3 listed)
- Glanular hypospadias.
- Penoscrotal, Scrotal \& Perineal hypospadias.
- Recurrent cases.
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 |
|---|---|---|
| Hypospadias repairsurgical repair of hypospadias | Procedure or surgery | Dartos Fascia, Tunica Vaginalis |
Primary outcome
Fistula
Time frame: Within the first three months after surgery.
Fistula prevalence will be recorded as a complication after surgery
1 secondary outcome
Cosmetic outcome
Time frame: Within the first three months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- 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 study testing Hypospadias repair in people with Pediatric Disorder and Hypospadias, run by Mansoura 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 2 inclusion and 3 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 17 Nov 2021. 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.
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?
Fistula (time frame: Within the first three months after surgery.). 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 17 Nov 2021.