Proximal HypospadiasNCT06598215
Hybrid Duckett vs Modified Duckett Urethroplasty for Proximal Hypospadias
A study testing Duckett urethroplasty in people with Proximal Hypospadias and Modified Duckett Urethroplasty, run by Tanta University at 1 site in Egypt.
Trial summary
proximal hypospadias presents a serious anomaly for both infants and their care givers. a variety of techniques were described through decades. None of them is completely curable. hundred of modifications were adopted to the original techniques. Read more about this study
- Who is it for?
- Ages 6 months to 18 years, men only
- Conditions the study is for
- Proximal Hypospadias, Modified Duckett Urethroplasty
- What is being tested?
- Duckett urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Aug 2026
- 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 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- all infants and children with proximal hypospadias
Who cannot join
- disorders of sex developments
- previous penile surgery
- circumcised children
- crippled penis
- refusal of the plan of the management by the care givers
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Elgharbeya, 31111
suzan Ezzat, professor, 00201010477452, souzan.gado@med.tanta.edu.eg
Nagi Eldessouki, professor, 00201227465887, neldessouki@med.tanta.edu.eg
About this study
Official title: Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias: a Randomized Clinical Trial
proximal hypospadias presents a serious anomaly for both infants and their care givers. a variety of techniques were described through decades. None of them is completely curable. hundred of modifications were adopted to the original techniques. during the current study, we will do hybrid Duckett urethroplasty which is a staged procedure and compare it to modified Duckett urethroplasty which is a single stage procedure.
Read the detailed description
two groups of infants diagnosed with proximal hypospadias will be allocated in two groups. group A will include cases of who will be operated upon using hybrid Duckett urethroplasty. group B will include patients who will be operated upon using modified duckett urethroplasty.
recruitment in either group will be done using sealed envelop method. in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis. the tube will be secured in place however, no proximal anastomosis with the meatus. the anastomosis will be scheduled six months later. In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session. the primary out come will be completion of the procedure and restoration of the urethral continuity. secondary out come will the cosmetic appearance
- Being tested
- Duckett urethroplasty
- Keywords
- proximal hypospadias, staged repair, Duckett urethroplasty, urethrocutaneous fistula, chodree
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duckett urethroplastyProcedure or surgery
hybrid duckett urethroplasty vs modified duckett urethroplasty
| Study group | Role | What they receive |
|---|---|---|
| group A hybrid Duckett urethroplasty | Active comparator | Not described Receives: Procedure: Duckett urethroplasty |
| group B modified Duckett urethroplasty | Active comparator | Not described Receives: Procedure: Duckett urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
repair of proximal hypospadias without fistula
strong strait stream of urine, no fistula formation, no urethral stricture
Measured: six months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal HypospadiasStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gharieb Mohammad Khirallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598215
- Sponsor's protocol ID
- 35171/12/21
- Status last verified
- Sep 2024
- First submitted
- 17 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the preoperative photos, operative photos and postoperative photos will be sharable with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06598215
- Acronym / sponsor ID
- 35171/12/21
- Keywords
- proximal hypospadias, staged repair, Duckett urethroplasty, urethrocutaneous fistula, chodree
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
proximal hypospadias presents a serious anomaly for both infants and their care givers. a variety of techniques were described through decades. None of them is completely curable. hundred of modifications were adopted to the original techniques. during the current study, we will do hybrid Duckett urethroplasty which is a staged procedure and compare it to modified Duckett urethroplasty which is a single stage procedure.
Detailed description
two groups of infants diagnosed with proximal hypospadias will be allocated in two groups. group A will include cases of who will be operated upon using hybrid Duckett urethroplasty. group B will include patients who will be operated upon using modified duckett urethroplasty.
recruitment in either group will be done using sealed envelop method. in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis. the tube will be secured in place however, no proximal anastomosis with the meatus. the anastomosis will be scheduled six months later. In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session. the primary out come will be completion of the procedure and restoration of the urethral continuity. secondary out come will the cosmetic appearance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A hybrid Duckett urethroplasty | Active comparator | Procedure: Duckett urethroplasty |
| group B modified Duckett urethroplasty | Active comparator | Procedure: Duckett urethroplasty |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all infants and children with proximal hypospadias
Key exclusion criteria (5 listed)
- disorders of sex developments
- previous penile surgery
- circumcised children
- crippled penis
- refusal of the plan of the management by the care givers
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 |
|---|---|---|
| Duckett urethroplastyhybrid duckett urethroplasty vs modified duckett urethroplasty | Procedure or surgery | group A hybrid Duckett urethroplasty, group B modified Duckett urethroplasty |
Primary outcome
repair of proximal hypospadias without fistula
Time frame: six months post operative
strong strait stream of urine, no fistula formation, no urethral stricture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. the preoperative photos, operative photos and postoperative photos will be sharable with other researchers
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duckett urethroplasty in people with Proximal Hypospadias and Modified Duckett Urethroplasty, run by Tanta 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 5 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 19 Sep 2024. 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?
Contact mohammad khirallah, professor (00201118420783, mohamed.khirallah@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
repair of proximal hypospadias without fistula (time frame: six months post operative). 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 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.