Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-30 @ 5:41 PM
Study NCT ID:
NCT07076992
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dilemma of Neonatal Circumcision in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-19', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post circumcision bleeding', 'timeFrame': '2 hours postoperatively', 'description': 'All infants will be followed up for 2 hours for early detection and management of post circumcision bleeding.'}], 'secondaryOutcomes': [{'measure': 'Wound healing', 'timeFrame': '7 days postoperatively', 'description': 'Superficial wound healing will be assessed on the 7th post-operative day.'}, {'measure': 'Parental satisfaction', 'timeFrame': '4 weeks postoperatively', 'description': 'Degree of parental satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonate', 'Circumcision']}, 'descriptionModule': {'briefSummary': 'The study aims to compare wound healing, wound healing complications, cosmetic outcome, and level of parental satisfaction amongst four techniques of neonatal circumcision.', 'detailedDescription': 'Circumcision of a male child is the most common surgery performed globally. The prevalence of circumcision in this part of the world is over 80%, with the majority conducted in the neonatal period. The techniques of circumcision are diverse, and the method of circumcision may account for the differences in the outcome of the procedure.\n\nCircumcision has complications like all surgical procedures. These typically include early complications such as leakage, hemorrhage, wound infection, pain, and swelling. However, more serious problems such as prolonged bleeding and amputation of the glans penis may also be encountered.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'genderBased': True, 'genderDescription': 'Male infants undergoing circumcision', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male infants less than 3 months old.\n* Undergoing circumcision.\n\nExclusion Criteria:\n\n* Male infants more than 3 months old.\n* Infants with bleeding disorders.\n* Neonates with hypospadias, epispadias, micropenis, disorders of sex development (DSD)\n* Neonates with buried or webbed penis.'}, 'identificationModule': {'nctId': 'NCT07076992', 'briefTitle': 'Dilemma of Neonatal Circumcision in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Dilemma of Neonatal Circumcision in Egypt: A Comparative Randomized Study', 'orgStudyIdInfo': {'id': '36264PR1075/1/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Patients will undergo circumcision by Plastibell (PB).', 'interventionNames': ['Procedure: Circumcision by Plastibell']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Patients will undergo circumcision by the Gomco (GM).', 'interventionNames': ['Procedure: Circumcision by Gomco']}], 'interventions': [{'name': 'Circumcision by Plastibell', 'type': 'PROCEDURE', 'description': 'Patients will undergo circumcision by Plastibell (PB).', 'armGroupLabels': ['Group 1']}, {'name': 'Circumcision by Gomco', 'type': 'PROCEDURE', 'description': 'Patients will undergo circumcision by the Gomco (GM).', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed I Elmaadawy, MD', 'role': 'CONTACT', 'email': 'Mohamed.elmaadawy@med.tanta.edu.eg', 'phone': '00201060245430'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mohamed I Elmaadawy, MD', 'role': 'CONTACT', 'email': 'Mohamed.elmaadawy@med.tanta.edu.eg', 'phone': '00201060245430'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohamed Ibrahim Ahmed Elmaadawy', 'investigatorAffiliation': 'Tanta University'}}}}