Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-04 @ 8:39 AM
Study NCT ID:
NCT04239066
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2020-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014111', 'term': 'Tourniquets'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-01-20', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess Intraoperative blood loss', 'timeFrame': '12 months', 'description': 'by blood loss in milliliter in used gauze piece'}, {'measure': 'bipolar diathermy use', 'timeFrame': '12 months', 'description': 'by number of bipolar diathermy usage'}, {'measure': 'Surgeon satisfaction about haemostasis', 'timeFrame': '12 months', 'description': 'Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).'}], 'secondaryOutcomes': [{'measure': 'Patient-reported satisfaction', 'timeFrame': '24 months', 'description': 'by hypospadias objective scoring evaluation (HOSE) questionnaire'}, {'measure': 'Long term complication rate', 'timeFrame': '60 months', 'description': 'number of surgery related complication after 5 years post operative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tourniquet', 'Hypospadias'], 'conditions': ['Hypospadias', 'Hypospadias, Coronal', 'Hypospadia, Repair', 'Tourniquet']}, 'descriptionModule': {'briefSummary': 'Although haemostasis aimed to maintain bloodless surgical field for better exposure for the surgeon, cosmetic impact, and decreased breakdown of repair, there is no trials regarding the impact of haemostasis techniques on surgeon satisfaction during surgery and patients reported outcomes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair\n\nExclusion Criteria:\n\n* coagulopathy\n* sickle cell disease or sickle cell trait\n* circumcised patient\n* history of previous failed surgery\n* severe chordee (\\>30 degree after degloving).'}, 'identificationModule': {'nctId': 'NCT04239066', 'briefTitle': 'Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes. A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'TOURNIQUE.HYPOSPADIAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tourniquet', 'description': 'tubularized incided plate (TIP) urethroplasty plus tourniquet', 'interventionNames': ['Procedure: Tourniquet']}, {'type': 'EXPERIMENTAL', 'label': 'Non-tourniquet', 'description': 'tubularized incided plate (TIP) urethroplasty plus non-tourniquet', 'interventionNames': ['Procedure: Non-tourniquet']}], 'interventions': [{'name': 'Tourniquet', 'type': 'PROCEDURE', 'description': 'tubularized incided plate (TIP) urethroplasty plus tourniquet', 'armGroupLabels': ['Tourniquet']}, {'name': 'Non-tourniquet', 'type': 'PROCEDURE', 'description': 'tubularized incided plate (TIP) urethroplasty plus non-tourniquet', 'armGroupLabels': ['Non-tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Outside U.S./Canada', 'country': 'Egypt', 'facility': 'Urology and nephrology center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohammed Dawaba, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}