Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04946058
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hybrid Mathieu Urethroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'successful treatment of distal penile hypospadias', 'timeFrame': '6 moths post operative', 'description': 'use of HOSE as a measure o success o repair'}, {'measure': 'increase the scope of classic Mathieu urethroplasty', 'timeFrame': '6 months post operative', 'description': 'cases with glanular width from 10 mm to 15 mm were included'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['distal hypospadias', 'Mathieu urethroplasty', 'modified', 'urethral plate'], 'conditions': ['Distal Penile Hypospadias (Disorder)']}, 'descriptionModule': {'briefSummary': 'the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.', 'detailedDescription': 'background: Distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. Successful hypospadias repair should provide a functional penis and good cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic Mathieu urethroplasty.\n\nMethods: forty-three patients with distal hypospadias were operated by hybrid Mathieu urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri meatal based flap was performed as Mathieu disrobed. This was followed by developing of glanular wings. The additional step was deep incision of the urethral plate. Then, urethroplasty was performed. The catheter was left in place for one to three days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '6 Months', 'genderBased': True, 'genderDescription': 'all male infants and children suffering from distal penile hypospadias', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* distal penile hypospadias\n\nExclusion Criteria:\n\n* sever hypospadias\n* cases need redo'}, 'identificationModule': {'nctId': 'NCT04946058', 'briefTitle': 'Hybrid Mathieu Urethroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'orgStudyIdInfo': {'id': '34403//1/21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'hyebrid Mathieu Urethroplasty', 'type': 'PROCEDURE', 'description': 'incision of the urethral plate during the procedure'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'publishing an article including the operative details and results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of pediatric surgery', 'investigatorFullName': 'Mohammad Gharieb Mohammad Khirallah', 'investigatorAffiliation': 'Tanta University'}}}}