Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 7:39 PM
Study NCT ID:
NCT07424768
Status:
COMPLETED
Last Update Posted:
2026-02-20
First Post:
2026-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Re-operative Hypospadias Repair Using Tubularized Incised Plate Urethroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2026-02-14', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '6 months after the procedure', 'description': 'The success rate of tubularized incised plate urethroplasty reoperation after treatment was recorded.'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': '6 months after the procedure', 'description': 'Incidence of postoperative complications such as fistula, meatal stenosis, glans dehiscence, and urethral stricture were recorded.'}, {'measure': 'Incidence of postoperative urethrocutaneous fistula', 'timeFrame': '6 months after the procedure', 'description': 'Incidence of postoperative urethrocutaneous fistula was recorded.'}, {'measure': 'Incidence of meatal stenosis', 'timeFrame': '6 months after the procedure', 'description': 'Incidence of meatal stenosis was recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Re-operative', 'Hypospadias', 'Tubularized Incised Plate', 'Urethroplasty']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the outcomes, feasibility, and complication profile of re-operative hypospadias repair using tubularized incised plate urethroplasty as a single-stage procedure in a single-center experience.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will conduct a retrospective review of 15 pediatric cases who presented or referred with complications requiring reoperation after primary hypospadias repair, including urethrocutaneous fistula, meatal stenosis, or poor urinary stream. This study will be conducted at Tanta university hospitals from January 2021 to december 2025. The data will be collected from 1st January 2026 to 1st February 2026.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both sexes.\n* 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.\n\nExclusion Criteria:\n\n* Patients with severely scared or fibrotic urethral plates are not suitable for tubularization.\n* Absent or destroyed urethral plates following previous failed hypospadias repairs.\n* Patients require staged urethral reconstruction rather than a single-stage procedure.\n* Presence of poor urethral plate vascularity or ischemic tissue.\n* Extensive penile scarring or fibrosis resulting from multiple previous surgical attempts.\n* Severe penile curvature requiring excision of the urethral plate.\n* Inability to achieve adequate, well-vascularized tissue coverage over the neourethra.'}, 'identificationModule': {'nctId': 'NCT07424768', 'briefTitle': 'Re-operative Hypospadias Repair Using Tubularized Incised Plate Urethroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Re-operative Hypospadias Repair Using Tubularized Incised Plate Urethroplasty', 'orgStudyIdInfo': {'id': '36264PR1310136/1/26'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Children with recurrent or residual hypospadias in whom the urethral plate is deemed suitable for reuse.', 'interventionNames': ['Procedure: Tubularized Incised Plate Urethroplasty']}], 'interventions': [{'name': 'Tubularized Incised Plate Urethroplasty', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatric Surgery, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Rami Mohamed Salama', 'investigatorAffiliation': 'Tanta University'}}}}