Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:48 AM
Study NCT ID:
NCT05817760
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2023-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2023-03-19', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed', 'timeFrame': 'One post-operative year', 'description': 'Post-operative follow up for the detection of penile edema, hematoma, skin coverage and the development of any wound contracture and consequently recurrent webbing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Penoscrotal web', 'Z-scrotoplasty', 'Heineke-Mikulicz'], 'conditions': ['Urologic Diseases']}, 'referencesModule': {'references': [{'pmid': '38519937', 'type': 'DERIVED', 'citation': 'Elrouby A. Evaluation of Z-plasty versus Heineke-Mikulicz scrotoplasty in the management of penoscrotal web in pediatric age group. BMC Urol. 2024 Mar 22;24(1):66. doi: 10.1186/s12894-024-01450-7.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the surgical outcome of Z-scrotoplasty versus Heineke-Mikulicz scrotoplasty in the management of congenital penoscrotal web in pediatric age group.\n\nThe main question\\[s\\] it aims to answer are:\n\n• Question 1: Is there a difference in the surgical outcome between using Z-scrotoplasty and Heinke Miculickz scrotoplasty in the management of congenital penoscrotal web?\\] Participants will be divided into two groups; Group A treated by Z-scrotoplasty and Group B treated by Heineke Miculickz scrotoplasty.', 'detailedDescription': 'Background: The penoscrotal web may be congenital or acquired after excessive removal of ventral skin during circumcision. There are several previously described surgical techniques for the treatment of congenital webbed penis without a clear comparison between their outcomes. Purpose: the objective of our study was to compare the surgical results of Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in the treatment of congenital webbed penis. Patients \\& Methods: Our prospective study included 40 uncircumcised patients presented with a webbed penis. They were divided into group A which was treated by Z-scrotoplasty and group B which was treated by Heineke-Mikulicz scrotoplasty.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with congenital penoscrotal web in the pediatric age group\n\nExclusion Criteria:\n\n* Patients with any penile anomalies'}, 'identificationModule': {'nctId': 'NCT05817760', 'briefTitle': 'Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web', 'organization': {'class': 'NETWORK', 'fullName': 'Egyptian Biomedical Research Network'}, 'officialTitle': 'Evaluation of Z-plasty Versus Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web in Pediatric Age Group', 'orgStudyIdInfo': {'id': '0305354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Z-scrotoplasty', 'description': 'Pediatric patients with congenital penoscrotal web who will be treated by Z-scrotoplasty', 'interventionNames': ['Procedure: Z-scrotoplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Heineke-Mikulicz scrotoplasty', 'description': 'Pediatric patients with congenital penoscrotal web who will be treated by Heineke-Mikulicz scrotoplasty', 'interventionNames': ['Procedure: Heineke-Mikulicz scrotoplasty']}], 'interventions': [{'name': 'Z-scrotoplasty', 'type': 'PROCEDURE', 'description': 'Z shape incision of the penoscrotal web and closure', 'armGroupLabels': ['Z-scrotoplasty']}, {'name': 'Heineke-Mikulicz scrotoplasty', 'type': 'PROCEDURE', 'description': 'Transverse incision of the penoscrotal web with vertical closure', 'armGroupLabels': ['Heineke-Mikulicz scrotoplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Ahmed Elrouby, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Surgery department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egyptian Biomedical Research Network', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of pediatric Surgery', 'investigatorFullName': 'Ahmed Elrouby', 'investigatorAffiliation': 'Egyptian Biomedical Research Network'}}}}