Proximal Penile HypospadiasNCT06565286
Graft Versus Flap in Management of Proximal Penile Hypospadias
A study testing inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias in people with Proximal Penile Hypospadias, run by Sohag University at 1 site in Egypt.
Trial summary
Proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. Read more about this study
- Who is it for?
- Ages 6 months and older, men only
- Conditions the study is for
- Proximal Penile Hypospadias
- What is being tested?
- inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Aug 2024to 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 and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: more than 6 months.
- Type of hypospadias: proximal penile hypospadias (scrotal and penoscrotal variants)
Who cannot join
- Age: less than 6 months.
- Perineal hypospadias.
- circumcised patients.
- Previous hypospadias repair
- Raised serum creatinine, coagulopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag
ahmed abo hammady, Denominator, 01016631447, ahmedshaban71992@gmail.com
hazem elmoghazy, professor, 01096522289, moghazyh@yahoo.com
About this study
Official title: Inlay Inner Preputial Graft Versus Transverse Preputial Island Flap in Management of Proximal Penile Hypospadias
Proximal hypospadias (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. However, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the Holy Grail for hypospadias specialists.
Read the detailed description
The surgical plan for proximal hypospadias can be divided into single and staged operations. Single stage operations are often associated with high rates of complications and reoperations. Reportedly, complications occur in 20-50% of patients. Therefore, many pediatric surgeons are selecting staged procedures. Staged surgical repair of proximal forms of hypospadias has been proven to achieve successful both functional and cosmetic results. Although staged repair with inner preputial layer graft has regained popularity in the repair of proximal hypospadias; but Choosing between flaps or grafts to substitute the urethral plate in 2-stage hypospadias repair has been a matter of debate with no consensus in the literature.
Flaps have reliable blood supply that may be theoretically less liable for strictures or contractures. Grafts are more versatile, which can be used in primary and recurrent cases when healthy local skin is deficient.
In this study, our aim is to compare outcomes of grafts and flaps when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias (penoscrotal and scrotal types).
- Conditions
- Proximal Penile Hypospadias
- Being tested
- inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadiasProcedure or surgery
Also called graft versus flap in two-stage repair of proximal penile hypospadias
compare outcomes of inner preputial graft versus transverse preputial island flap when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias .
| Study group | Role | What they receive |
|---|---|---|
| inner preputial graft | Active comparator | managemet of proximal penile hypospadias in 2stage using inner preputial graft in the first stage Receives: Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias |
| transverse preputial island flap | Active comparator | managemet of proximal penile hypospadias in 2stage using transverse preputial island flap in the first stage Receives: Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure complications after staged repair of proximal penile hypospadias using different techniques.
urinary fistulas, urethral strictures, diverticula and failed repair.
Measured: 6 month after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start18 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Proximal Penile HypospadiasStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Model description
- Inlay inner preputial graft versus Transverse preputial island flap in management of proximal penile hypospadias
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shabaan Abohamady, Sohag University
- Investigators
- mohamed diaa, professor, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565286
- Sponsor's protocol ID
- Soh-Med-24-06-02MD
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Report the cosmotic and functional outcomes after staged repair of proximal penile hypospadias using different techniques.
Publications
Kojima Y, Kohri K, Hayashi Y. Genetic pathway of external genitalia formation and molecular etiology of hypospadias. J Pediatr Urol. 2010 Aug;6(4):346-54. doi: 10.1016/j.jpurol.2009.11.007. Epub 2009 Dec 7.
PubMed 19995686Bouty A, Ayers KL, Pask A, Heloury Y, Sinclair AH. The Genetic and Environmental Factors Underlying Hypospadias. Sex Dev. 2015;9(5):239-259. doi: 10.1159/000441988. Epub 2015 Nov 28.
PubMed 26613581Hsieh MH, Breyer BN, Eisenberg ML, Baskin LS. Associations among hypospadias, cryptorchidism, anogenital distance, and endocrine disruption. Curr Urol Rep. 2008 Mar;9(2):137-42. doi: 10.1007/s11934-008-0025-0.
PubMed 18419998
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inlay Inner Preputial Graft Versus Transverse Preputial Island Flap in Management of Proximal Penile Hypospadias
- ClinicalTrials.gov ID
- NCT06565286
- Acronym / sponsor ID
- Soh-Med-24-06-02MD
- Conditions
- Proximal Penile Hypospadias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Aug 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 (penoscrotal, scrotal, and perineal types) account for approximately 20% of all cases . The management of hypospadias has greatly improved over the past two decades since the introduction of tubularized incisized plate urethroplasty. However, obtaining a favorable cosmetic outcome and functional straight penis is a major surgical challenge for such patients, and the ideal repair of proximal hypospadias remains the Holy Grail for hypospadias specialists.
Detailed description
The surgical plan for proximal hypospadias can be divided into single and staged operations. Single stage operations are often associated with high rates of complications and reoperations. Reportedly, complications occur in 20-50% of patients. Therefore, many pediatric surgeons are selecting staged procedures. Staged surgical repair of proximal forms of hypospadias has been proven to achieve successful both functional and cosmetic results. Although staged repair with inner preputial layer graft has regained popularity in the repair of proximal hypospadias; but Choosing between flaps or grafts to substitute the urethral plate in 2-stage hypospadias repair has been a matter of debate with no consensus in the literature.
Flaps have reliable blood supply that may be theoretically less liable for strictures or contractures. Grafts are more versatile, which can be used in primary and recurrent cases when healthy local skin is deficient.
In this study, our aim is to compare outcomes of grafts and flaps when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias (penoscrotal and scrotal types).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Inlay inner preputial graft versus Transverse preputial island flap in management of proximal penile hypospadias
| Arm | Type | Receives |
|---|---|---|
| inner preputial graft | Active comparator | Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadiasmanagemet of proximal penile hypospadias in 2stage using inner preputial graft in the first stage |
| transverse preputial island flap | Active comparator | Procedure: inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadiasmanagemet of proximal penile hypospadias in 2stage using transverse preputial island flap in the first stage |
Who may qualify
- Ages
- 6 months and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age: more than 6 months.
- Type of hypospadias: proximal penile hypospadias (scrotal and penoscrotal variants)
Key exclusion criteria (5 listed)
- Age: less than 6 months.
- Perineal hypospadias.
- circumcised patients.
- Previous hypospadias repair
- Raised serum creatinine, coagulopathy.
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 |
|---|---|---|
| inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadiasAlso: graft versus flap in two-stage repair of proximal penile hypospadiascompare outcomes of inner preputial graft versus transverse preputial island flap when used to substitute the urethral plate in two-stage repair of primary proximal penile hypospadias . | Procedure or surgery | inner preputial graft, transverse preputial island flap |
Primary outcome
measure complications after staged repair of proximal penile hypospadias using different techniques.
Time frame: 6 month after end of treatment
urinary fistulas, urethral strictures, diverticula and failed repair.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Results publication: PubMed 19995686Kojima Y, Kohri K, Hayashi Y. Genetic pathway of external genitalia formation and molecular etiology of hypospadias. J Pediatr Urol. 2010 Aug;6(4):346-54. doi: 10.1016/j.jpurol.2009.11.007. Epub 2009 Dec 7.
- Results publication: PubMed 26613581Bouty A, Ayers KL, Pask A, Heloury Y, Sinclair AH. The Genetic and Environmental Factors Underlying Hypospadias. Sex Dev. 2015;9(5):239-259. doi: 10.1159/000441988. Epub 2015 Nov 28.
- Results publication: PubMed 18419998Hsieh MH, Breyer BN, Eisenberg ML, Baskin LS. Associations among hypospadias, cryptorchidism, anogenital distance, and endocrine disruption. Curr Urol Rep. 2008 Mar;9(2):137-42. doi: 10.1007/s11934-008-0025-0.
- Genetic pathway of external genitalia formation and molecular etiology of hypospadiasLink provided by the sponsor.
- The Genetic and Environmental Factors Underlying HypospadiasLink provided by the sponsor.
- Associations among hypospadias, cryptorchidism, anogenital distance, and endocrine disruptionLink provided by the sponsor.
- Individual participant dataSharing planned: No. Report the cosmotic and functional outcomes after staged repair of proximal penile hypospadias using different techniques.
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.
mohamed diaa, professor study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inner preputial graft versus transverse preputial island flap in two-stage repair of proximal penile hypospadias in people with Proximal Penile Hypospadias, run by Sohag 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 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 21 Aug 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 ahmed abohammady, denominator (01016631447, ahmedshaban71992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure complications after staged repair of proximal penile hypospadias using different techniques. (time frame: 6 month after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06565286, which also lists 3 linked publications.
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 21 Aug 2024.