Hypospadias, PenoscrotalNCT06165120
Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)
A study testing Bracka's repair using preputial graft and STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap in people with Hypospadias, Penoscrotal, run by Sohag University at 1 site in Egypt.
Trial summary
Hypospadias is a male congenital anomaly characterized by the abnormally located urethral meatus being displaced along the ventral side of the penis along a line from the tip of glans penis to the perineum. Read more about this study
- Who is it for?
- Ages 6 months to 18 years, men only
- Conditions the study is for
- Hypospadias, Penoscrotal
- What is being tested?
- Bracka's repair using preputial graft and STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to Dec 2024
- 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 patients with proximal hypospadias with marked ventral curvature (>30 degrees) who presented to the outpatient clinic of Department of Pediatric Surgery in Sohag University Hospital.
Who cannot join
- Patients with insufficient follow up data or those who are non-compliant on follow up.
- Previously circumcised patients.
- Patients with complex urogenital malformations or DSD.
- Patients with ventral curvature less than 30 degrees.
- Patients with crippled hypospadias.
Trial locations and contacts
1 site in 1 country.
Ahmed M Abd El-Moniem Gafar, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag, 82511
Ahmed M Mahmoud Abd Allah, 01144345755, ahmedmahmoud@med.sohag.edu.eg
About this study
Hypospadias is a male congenital anomaly characterized by the abnormally located urethral meatus being displaced along the ventral side of the penis along a line from the tip of glans penis to the perineum.
Hypospadias is one of the most common congenital malformations of the male genitourinary system, with a reported global incidence of 0.6-34.2 per 10,000 live births. There is more than one classification for hypospadias. Most commonly, hypospadias is classified into proximal \& distal hypospadias which mainly affects the decision for the corrective procedure.
Read more
Correction of proximal hypospadias remains a surgical challenge, which is mainly due to the pathological features of proximal hypospadias including a more proximal meatus, severe ventral chordee, and the need to transect the urethral plate during the operation.
The use of a 2-stage repair was found to achieve more satisfactory functional and cosmetic outcomes for proximal hypospadias with severe ventral chordee . Bracka repair, first described in 1995 by Bracka, is a 2-stage repair which uses grafts. This procedure has been improved over time, and recently it has been associated with satisfactory outcomes in proximal hypospadias with severe ventral curvature. Staged transverse preputial island flap urethroplasty (STPIF), first reported by Chen et al., is another 2-stage repair using flaps based on the traditional transverse preputial island flap (TPIF). STPIF has been shown to reduce the difficulty of surgery and the complication rate in management of proximal hypospadias. Thus, both Bracka repair and STPIF are valuable 2-stage methods, and both have achieved promising results. However, there are no available clear comparative data for determination which method has a better outcome and less complications in treating proximal hypospadias.
This study compares Bracka's procedure using preputial grafts and STPIF (Staged Preutial Island Flap) procedure using preputial flaps in surgical correction of proximal hypospadias with marked ventral curvtaure.
- Conditions
- Hypospadias, Penoscrotal
- Being tested
- Bracka's repair using preputial graft, STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bracka's repair using preputial graftProcedure or surgery
Staged repair:
- Correction of ventral chordee: by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test.
- Preputial graft placement: a graft will be designed on the inner layer of the preputial hood, according to the length of the urethra defect. Fixation of the free graft will be performed along the whole defective urethral plate. A compression dressing will be used for the transplanted graft. At the end of the surgery, a urinary catheter will be placed through the ectopic meatus.
- Tubularisation of the graft: this stage will be performed 6 months later. The new graft will be tubularised over a catheter. Then a protective layer may be made over the tubularization using a dartos or tunica vaginalis flap. After suturing of the penile skin and dressing of the penis, a urethral catheter would be retained for urinary diversion.
STPIF (Staged Transverse Preputial Island Flap) repair using preputial flapProcedure or surgery
Staged repair:
- Correction of ventral chordee; by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test.
- Preputial flap placement: according to the distance between the ectopic meatus and the glans tip, a transverse rectangular flap will be dissected from the inner layer of the dorsal prepuce. The flap will be placed along the defective urethral plate. Eventually, a silicon indwelling catheter will be placed through the ectopic meatus.
- Tubularisation of the flap: this stage procedure would be performed 6 months after the first procedure. Tubularisation of the the preputial flap will be done over a catheter. Byar's flaps may be created and transposed to cover the neourethra. Eventually, the penis will be dressed, and a urethral catheter will be retained for urinary diversion.
| Study group | Role | What they receive |
|---|---|---|
| group A; Bracka's repair group | Active comparator | This group will undergo Bracka's repair using preputial graft in treatment of proximal hypospadias with marked ventral curvature Receives: Procedure: Bracka's repair using preputial graft |
| group B; STPIF repair group | Active comparator | This group will undergo STPIF repair using preputial flap in treatment of proximal hypospadias with marked ventral curvature Receives: Procedure: STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of residual ventral curvature
measured in degrees; if less than 15 degrees it's acceptable, if more than 15 degrees it will need further correction
Measured: 1 year
Incidence of meatal stenosis
calibrated by urethral Hegar's dilators according to the age
Measured: 1 year
Incidence of urethral stricture
calibrated by urethral Hegar's dilators according to the age
Measured: 1 year
Incidence of glans dehiscence
evaluated subjectively by the patients or the parents using questionnaires and objectively by the surgeons
Measured: 1 year
Incidence of urethro-cutaneous fistula
measured in millimeters; if less than 3 millimeters it's a micro-fistula, if it's more than 3 millimeters it's a macro-fistula
Measured: 1 year
Incidence of urethral diverticula formation
evaluated by voiding problems
Measured: 1 year
Incidence of graft/flap fibrosis after the first stage
evaluated objectively by signs of inflammation, necrosis and fibrosis
Measured: 1 year
Percentage of patients with accepted cosmetic appearance
assessed by questionnaires obtained from the patients and/or the parents
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypospadias, PenoscrotalStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165120
- Sponsor's protocol ID
- Soh-Med-23-10-013MS
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preputial Graft Versus Preputial Flap in Treatment of Proximal Hypospadias With Marked Ventral Curvature (a Comparative Study)
- ClinicalTrials.gov ID
- NCT06165120
- Acronym / sponsor ID
- Soh-Med-23-10-013MS
- Conditions
- Hypospadias, Penoscrotal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Dec 2023 (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.
Hypospadias is a male congenital anomaly characterized by the abnormally located urethral meatus being displaced along the ventral side of the penis along a line from the tip of glans penis to the perineum.
Hypospadias is one of the most common congenital malformations of the male genitourinary system, with a reported global incidence of 0.6-34.2 per 10,000 live births. There is more than one classification for hypospadias. Most commonly, hypospadias is classified into proximal \& distal hypospadias which mainly affects the decision for the corrective procedure.
Correction of proximal hypospadias remains a surgical challenge, which is mainly due to the pathological features of proximal hypospadias including a more proximal meatus, severe ventral chordee, and the need to transect the urethral plate during the operation.
The use of a 2-stage repair was found to achieve more satisfactory functional and cosmetic outcomes for proximal hypospadias with severe ventral chordee . Bracka repair, first described in 1995 by Bracka, is a 2-stage repair which uses grafts. This procedure has been improved over time, and recently it has been associated with satisfactory outcomes in proximal hypospadias with severe ventral curvature. Staged transverse preputial island flap urethroplasty (STPIF), first reported by Chen et al., is another 2-stage repair using flaps based on the traditional transverse preputial island flap (TPIF). STPIF has been shown to reduce the difficulty of surgery and the complication rate in management of proximal hypospadias. Thus, both Bracka repair and STPIF are valuable 2-stage methods, and both have achieved promising results. However, there are no available clear comparative data for determination which method has a better outcome and less complications in treating proximal hypospadias.
This study compares Bracka's procedure using preputial grafts and STPIF (Staged Preutial Island Flap) procedure using preputial flaps in surgical correction of proximal hypospadias with marked ventral curvtaure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A; Bracka's repair group | Active comparator | Procedure: Bracka's repair using preputial graftThis group will undergo Bracka's repair using preputial graft in treatment of proximal hypospadias with marked ventral curvature |
| group B; STPIF repair group | Active comparator | Procedure: STPIF (Staged Transverse Preputial Island Flap) repair using preputial flapThis group will undergo STPIF repair using preputial flap in treatment of proximal hypospadias with marked ventral curvature |
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 patients with proximal hypospadias with marked ventral curvature (>30 degrees) who presented to the outpatient clinic of Department of Pediatric Surgery in Sohag University Hospital.
Key exclusion criteria (5 listed)
- Patients with insufficient follow up data or those who are non-compliant on follow up.
- Previously circumcised patients.
- Patients with complex urogenital malformations or DSD.
- Patients with ventral curvature less than 30 degrees.
- Patients with crippled hypospadias.
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 |
|---|---|---|
| Bracka's repair using preputial graftStaged repair: 1. Correction of ventral chordee: by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test. 2. Preputial graft placement: a graft will be designed on the inner layer of the preputial hood, according to the length of the urethra defect. Fixation of the free graft will be performed along the whole defective urethral plate. A compression dressing will be used for the transplanted graft. At the end of the surgery, a urinary catheter will be placed through the ectopic meatus. 3. Tubularisation of the graft: this stage will be performed 6 months later. The new graft will be tubularised over a catheter. Then a protective layer may be made over the tubularization using a dartos or tunica vaginalis flap. After suturing of the penile skin and dressing of the penis, a urethral catheter would be retained for urinary diversion. | Procedure or surgery | group A; Bracka's repair group |
| STPIF (Staged Transverse Preputial Island Flap) repair using preputial flapStaged repair: 1. Correction of ventral chordee; by degloving of the penile skin, transection of the urethral plate \&/or ventral corporotomy through the tunica albuginea. This will be according to the degree of ventral chordee after artificial erection test. 2. Preputial flap placement: according to the distance between the ectopic meatus and the glans tip, a transverse rectangular flap will be dissected from the inner layer of the dorsal prepuce. The flap will be placed along the defective urethral plate. Eventually, a silicon indwelling catheter will be placed through the ectopic meatus. 3. Tubularisation of the flap: this stage procedure would be performed 6 months after the first procedure. Tubularisation of the the preputial flap will be done over a catheter. Byar's flaps may be created and transposed to cover the neourethra. Eventually, the penis will be dressed, and a urethral catheter will be retained for urinary diversion. | Procedure or surgery | group B; STPIF repair group |
Primary outcome
Incidence of residual ventral curvature
Time frame: 1 year
measured in degrees; if less than 15 degrees it's acceptable, if more than 15 degrees it will need further correction
Incidence of meatal stenosis
Time frame: 1 year
calibrated by urethral Hegar's dilators according to the age
Incidence of urethral stricture
Time frame: 1 year
calibrated by urethral Hegar's dilators according to the age
Incidence of glans dehiscence
Time frame: 1 year
evaluated subjectively by the patients or the parents using questionnaires and objectively by the surgeons
Incidence of urethro-cutaneous fistula
Time frame: 1 year
measured in millimeters; if less than 3 millimeters it's a micro-fistula, if it's more than 3 millimeters it's a macro-fistula
Incidence of urethral diverticula formation
Time frame: 1 year
evaluated by voiding problems
Incidence of graft/flap fibrosis after the first stage
Time frame: 1 year
evaluated objectively by signs of inflammation, necrosis and fibrosis
Percentage of patients with accepted cosmetic appearance
Time frame: 1 year
assessed by questionnaires obtained from the patients and/or the parents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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.
Ahmed M Abd El-Moniem Gafar, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bracka's repair using preputial graft and STPIF (Staged Transverse Preputial Island Flap) repair using preputial flap in people with Hypospadias, Penoscrotal, 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 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 11 Dec 2023. 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 M Mahmoud Abd Allah, Resident (01144345755, ahmedmahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of residual ventral curvature (time frame: 1 year). The study lists 8 primary outcomes in all. 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 11 Dec 2023.