Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 7:47 PM
Study NCT ID:
NCT05123833
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D005402', 'term': 'Fistula'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula', 'timeFrame': 'Within the first three months after surgery.', 'description': 'Fistula prevalence will be recorded as a complication after surgery'}], 'secondaryOutcomes': [{'measure': 'Cosmetic outcome', 'timeFrame': 'Within the first three months after surgery.', 'description': "Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypospadias repair', 'Tunica Vaginalis Flap', 'Dartos Fascia', 'Fistula'], 'conditions': ['Pediatric Disorder', 'Hypospadias', 'Congenital Hypospadia', 'Urologic Diseases']}, 'descriptionModule': {'briefSummary': 'To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'genderBased': True, 'genderDescription': 'males less than 12 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 6 months.\n* Distal, mid-shaft penile hypospadias.\n\nExclusion Criteria:\n\n* Glanular hypospadias.\n* Penoscrotal, Scrotal \\& Perineal hypospadias.\n* Recurrent cases.'}, 'identificationModule': {'nctId': 'NCT05123833', 'briefTitle': 'The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Hypospadias-UC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dartos Fascia', 'description': 'Dartos flap is used as a covering layer for urethra during repair of hypospadias', 'interventionNames': ['Procedure: Hypospadias repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tunica Vaginalis', 'description': 'Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias', 'interventionNames': ['Procedure: Hypospadias repair']}], 'interventions': [{'name': 'Hypospadias repair', 'type': 'PROCEDURE', 'description': 'surgical repair of hypospadias', 'armGroupLabels': ['Dartos Fascia', 'Tunica Vaginalis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}