Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-08 @ 11:38 AM
Study NCT ID:
NCT03634358
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2018-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bipolar Scissors for Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparing Outcomes of two different surgical techniques between two groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2018-01-13', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative bleeding', 'timeFrame': 'A week', 'description': 'occurrence of active bleeding after circumcision'}], 'secondaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': 'A week', 'description': 'pain after operation as assessed and described by parents (through a questionnaire) by the Neonatal/Infant Pain Scale (NIPS): It is composed of six (6) indicators.\n\n* facial expression\n* cry\n* breathing patterns\n* arms\n* legs\n* state of arousal Each behavioral indicator is scored with 0 or 1 except "cry", which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants should be observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7. Pain Level is determined as: 0-2 = mild to no pain. 3-4 = mild to moderate pain \\>4 = severe pain'}, {'measure': 'wound complications', 'timeFrame': 'Two weeks', 'description': 'occurrence of infection, necrosis or skin loss around wound'}, {'measure': 'Cosmetic outcome', 'timeFrame': 'Two month', 'description': 'Presence or absence of scar'}, {'measure': 'Operative time', 'timeFrame': 'Operative time', 'description': 'Duration of procedure of both techniques'}, {'measure': 'Over or under correction', 'timeFrame': '2 month', 'description': 'Excessive or insufficient removal of foreskin (presence of redundant skin or compression of penile length)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bipolar', 'scalpel', 'foreskin', 'prepuce'], 'conditions': ['Male Circumcision']}, 'referencesModule': {'references': [{'pmid': '19853772', 'type': 'BACKGROUND', 'citation': 'Mendez-Gallart R, Estevez E, Bautista A, Rodriguez P, Taboada P, Armas AL, Pradillos JM, Varela R. Bipolar scissors circumcision is a safe, fast, and bloodless procedure in children. J Pediatr Surg. 2009 Oct;44(10):2048-53. doi: 10.1016/j.jpedsurg.2009.06.008.'}]}, 'descriptionModule': {'briefSummary': 'comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method', 'detailedDescription': 'A prospective, randomized study, comparing two different techniques for pediatric male circumcision: the bipolar diathermy scissors technique with that of a classic scalpel technique. Study included male infants from 40 days old up to 18 month old. They were reviewed regarding Operative time, bleeding, complications, postoperative pain and morbidity. Differences in the outcome were compared.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '40 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male infant between 40 days and 18 month old\n* parents' request and approval of circumcision\n\nExclusion Criteria:\n\n* previous attempts of circumcision or revision cases\n* bleeding tendency\n* congenital anomalies involving genitalia\n* age below 40 days (expected Vit. K deficiency) or above 18 month old."}, 'identificationModule': {'nctId': 'NCT03634358', 'briefTitle': 'Bipolar Scissors for Circumcision', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Bipolar Scissors Versus Classic Method for Circumcision', 'orgStudyIdInfo': {'id': 'ZagazigUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bipolar scissors group', 'description': 'Group of male infants undergoing circumcision using bipolar scissors to separate the foreskin', 'interventionNames': ['Procedure: Bipolar scissors']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic scalpel group', 'description': 'Group of male infants undergoing circumcision using classic scalpel to separate the foreskin, and sutures to control bleeding', 'interventionNames': ['Procedure: classic scalpel']}], 'interventions': [{'name': 'Bipolar scissors', 'type': 'PROCEDURE', 'armGroupLabels': ['Bipolar scissors group']}, {'name': 'classic scalpel', 'type': 'PROCEDURE', 'armGroupLabels': ['Classic scalpel group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of general surgery, MD Candidate', 'investigatorFullName': 'yousef ahmed el-ayman', 'investigatorAffiliation': 'Zagazig University'}}}}