Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04699318
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2018-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-06', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2021-01-06', 'lastUpdatePostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of urethro-cutaneous fistula', 'timeFrame': '17 days', 'description': 'Abnormal communication between urethra and penile skin after urethroplasty, presenting with complaints of two streams of micturition and noted on examination at 17th postoperative day.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypospadias']}, 'descriptionModule': {'briefSummary': 'The subjects were divided into two groups. Each group comprised 30 children. Children were randomly allocated in two groups via computer generated tables. Children in group-A underwent single dartos tubularized incised plate urethroplasty while those in group-B underwent double dartos tubularized incised plate urethroplasty.', 'detailedDescription': 'In group A dartos flap is raised from foreskin of the patient and applied as a single layer after tubularization in between neourethra and skin . In group B dartos flap is raised from the foreskin of patient and divided in two equal halves.Both flaps are placed as two layers in between skin and neourethra.After surgery patient is kept in ward for 10 days with stent.Patient is followed up in OPD on after 7th day after discharge for outcome.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'genderBased': True, 'genderDescription': 'Male gender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria All the patients above one year of age All patients having distal and mid penile hypospadias. -\n\nExclusion Criteria Severe chordee Previously operated cases Patient with undescended testis Circumcised patient\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04699318', 'briefTitle': 'Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'To Compare the Frequency of Urethrocutaneous Fistula After Double Dartos Tubularized Incised Plate (TIP) Urethroplasty and Single Dartos Tubularized Incised', 'orgStudyIdInfo': {'id': 'KEMU1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Dartos TIP', 'description': 'Single dartos tubularized incised plate urethroplasty', 'interventionNames': ['Procedure: Group A']}, {'type': 'EXPERIMENTAL', 'label': 'Double Dartos TIP', 'description': 'Double dartos tubularized incised plate urethroplasty', 'interventionNames': ['Procedure: Group B']}], 'interventions': [{'name': 'Group B', 'type': 'PROCEDURE', 'otherNames': ['Double dartos TIP'], 'description': 'To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty', 'armGroupLabels': ['Double Dartos TIP']}, {'name': 'Group A', 'type': 'PROCEDURE', 'otherNames': ['Single dartos TIP'], 'description': 'To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty', 'armGroupLabels': ['Single Dartos TIP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '042', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'KEMU', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Asad Munir, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Edward Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Malik ASAD Munir', 'investigatorFullName': 'Malik Asad Munir', 'investigatorAffiliation': 'King Edward Medical University'}}}}