- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424768
Re-operative Hypospadias Repair Using Tubularized Incised Plate Urethroplasty
Study Overview
Status
Intervention / Treatment
Detailed Description
Hypospadias repair remains one of the most common reconstructive procedures in pediatric urology; however, re-operative hypospadias represents a challenging subset due to distorted anatomy, urethral plate scarring, deficient local tissues, and higher complication rates compared with primary repairs.
The tubularized incised plate (TIP) urethroplasty, originally described by Snodgrass, revolutionized primary hypospadias repair and has since been adapted for selected reoperative cases. Contemporary evidence suggests that despite prior surgery and scary, a well-vascularized urethral plate of adequate width can still be successfully tubularized following a midline relaxing incision, offering acceptable functional and cosmetic outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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El-Gharbia
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Tanta, El-Gharbia, Egypt, 31527
- Tanta University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Both sexes.
- Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse, defined as a plate width of at least 8-9 mm with acceptable vascularity and without severe fibrosis.
Exclusion Criteria:
- Patients with severely scared or fibrotic urethral plates are not suitable for tubularization.
- Absent or destroyed urethral plates following previous failed hypospadias repairs.
- Patients require staged urethral reconstruction rather than a single-stage procedure.
- Presence of poor urethral plate vascularity or ischemic tissue.
- Extensive penile scarring or fibrosis resulting from multiple previous surgical attempts.
- Severe penile curvature requiring excision of the urethral plate.
- Inability to achieve adequate, well-vascularized tissue coverage over the neourethra.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Study group
Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse.
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All procedures were performed under general anesthesia using the tubularized incised plate technique.
After completing penile degloving and exposure of the urethral plate, a midline longitudinal incision was made along the entire length of the plate to allow tension-free tubularization.
The urethral plate was then tubularized over an appropriate-sized urethral catheter using fine absorbable sutures.
A well-vascularized dartos flap was harvested and interposed as a protective layer over the neourethra, followed by meticulous skin closure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate
Time Frame: 6 months after the procedure
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The success rate of tubularized incised plate urethroplasty reoperation after treatment was recorded.
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6 months after the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of complications
Time Frame: 6 months after the procedure
|
Incidence of postoperative complications such as fistula, meatal stenosis, glans dehiscence, and urethral stricture were recorded.
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6 months after the procedure
|
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Incidence of postoperative urethrocutaneous fistula
Time Frame: 6 months after the procedure
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Incidence of postoperative urethrocutaneous fistula was recorded.
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6 months after the procedure
|
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Incidence of meatal stenosis
Time Frame: 6 months after the procedure
|
Incidence of meatal stenosis was recorded.
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6 months after the procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Male
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Congenital Abnormalities
- Urogenital Abnormalities
- Penile Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Hypospadias
Other Study ID Numbers
- 36264PR1310136/1/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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