Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 5:17 PM
Study NCT ID:
NCT06177834
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2023-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alisklamp and Dorsal Slit Sleeve 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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2023-12-10', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing time', 'timeFrame': '2 weeks', 'description': 'Healing time'}, {'measure': 'infections', 'timeFrame': '2 weeks', 'description': 'wound infections'}, {'measure': 'wound dehiscence', 'timeFrame': '2 weeks', 'description': 'wound dehiscence'}, {'measure': 'skin tunnel', 'timeFrame': '1 month', 'description': 'presense of the number of skin tunnel'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Circumcision']}, 'descriptionModule': {'briefSummary': 'In this study the plan is to compare the circumcision performed with Alisklamp versus Dorsal Slit Sleeve method in terms of age, co-existing health conditions, surgery time, recovery period, tissue edema and bleeding, postoperative infection, wound healing, wound dehiscence, skin tunnel, and overall complications.', 'detailedDescription': 'The study compares two circumcision techniques in children: the dorsal sleeve slit method and the alisclamp method. The dorsal sleeve slit technique, conducted under local anesthesia for about 20-30 minutes, involves cutting the penile skin dorsally, removing excess skin and prepuce, and suturing with 5/0 vicryl. The alisclamp method, also under local anesthesia, entails retracting the penile skin, placing a clamp, excising excess prepuce, and sending the patient home. The clamp is removed after 48 hours without anesthesia, with the total procedure lasting under 5 minutes. This research assesses these methods based on factors like age, co-existing health conditions, surgery time, recovery period, tissue edema and bleeding, postoperative infection, wound healing, wound dehiscence, skin tunnel, and overall complications.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Minute', 'genderBased': True, 'genderDescription': 'Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmale patients between 0-2 years and 6-18 years\n\nExclusion Criteria:\n\n2-6 years, several penil chordee, hypospadias, previous penil surgery'}, 'identificationModule': {'nctId': 'NCT06177834', 'briefTitle': 'Alisklamp and Dorsal Slit Sleeve Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'Necmi Kadıoğlu Hospital'}, 'officialTitle': 'Comparison of Alisklamp and Dorsal Slit Sleeve Circumcision: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NecmiKadiogluH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Classical dorsal slit circumcision technique', 'description': 'In this group, the patients who will operated with dorsal sleeve slit circumcision technique.', 'interventionNames': ['Other: Dorsal slit circumcision technique']}, {'type': 'EXPERIMENTAL', 'label': 'Alisklamp', 'description': 'In this group, the patients who will operated with Alisklamp technique.', 'interventionNames': ['Device: Alisklamp']}], 'interventions': [{'name': 'Alisklamp', 'type': 'DEVICE', 'description': 'Alisklamp', 'armGroupLabels': ['Alisklamp']}, {'name': 'Dorsal slit circumcision technique', 'type': 'OTHER', 'description': 'In this group, included the patients who will operated with dorsal slit circumcision technique', 'armGroupLabels': ['Classical dorsal slit circumcision technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34430', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Mustafa Azizoğlu', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mustafa Azizoğlu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necmi Kadıoğlu State Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mustafa Azizoğlu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mustafa Azizoğlu', 'investigatorAffiliation': 'Necmi Kadıoğlu Hospital'}}}}