Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 2:29 AM
Study NCT ID:
NCT05253456
Status:
COMPLETED
Last Update Posted:
2022-02-23
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Second Layer Repair for Distal Penile Hypospadias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urethro-cutaneous fistula', 'timeFrame': '1 year follow up', 'description': 'presence of urethro-cutaneous fistula after closure of hypospadias as assess by inspection for the presence of urinary fistula'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypospadias']}, 'descriptionModule': {'briefSummary': 'to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias', 'detailedDescription': 'In our study, we applied a new modification by using an intervening layer of a de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly applied technique and its impact on the success rate.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'genderBased': True, 'genderDescription': 'Hypospadias is congenital urethra defect in male urethra only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All male patient with distal penile hypospadias aged less than 18\n\nExclusion Criteria:\n\n* Patients with penile rotation or hypoplastic urethral plate were excluded from the study'}, 'identificationModule': {'nctId': 'NCT05253456', 'briefTitle': 'Modified Second Layer Repair for Distal Penile Hypospadias', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Modified Tubularized Incised Plate Urethroplasty (Snodgrass) For Distal Hypospadias Repair in a Circumcised Patient With the Use of a Derma -Dartos Flap for Second Layer Closure: Our Initial Experience', 'orgStudyIdInfo': {'id': 'R22/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'patients underwent our newly modified technique for hypospadias repair', 'interventionNames': ['Procedure: Derma -Dartos Flap for second layer closure']}], 'interventions': [{'name': 'Derma -Dartos Flap for second layer closure', 'type': 'PROCEDURE', 'description': 'usage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11757', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Maher', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Ahmed Maher Gamil Ahmed Higazy', 'investigatorAffiliation': 'Ain Shams University'}}}}