Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT06035302
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'closure time', 'timeFrame': '1 day', 'description': 'closure time in seconds'}, {'measure': 'rate of closure failure', 'timeFrame': '1 day', 'description': 'rate failure to close the port site'}], 'secondaryOutcomes': [{'measure': 'incidence of port site infection', 'timeFrame': '1 month', 'description': 'incidence of infection of the port site'}, {'measure': 'incidence of port site hernia', 'timeFrame': '6 weeks', 'description': 'incidence of hernia at the port site'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholecystolithiasis']}, 'descriptionModule': {'briefSummary': 'this study aims to evaluate the effectiveness of the use of a basic laparoscopic instrument (Only needle holder) with a new technique for port site closure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age . 18 years\n* eligible for Laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* refused to participate'}, 'identificationModule': {'nctId': 'NCT06035302', 'briefTitle': 'Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'ClinAmygate'}, 'officialTitle': 'Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'PR00C1940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Madany closure', 'description': 'the novel port site closure technique is to be done for this group', 'interventionNames': ['Procedure: Madany Closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'external closure of the port site', 'interventionNames': ['Procedure: Standard closure']}], 'interventions': [{'name': 'Madany Closure', 'type': 'PROCEDURE', 'description': 'Madany Closure is a new technique for the porte site closure', 'armGroupLabels': ['Madany closure']}, {'name': 'Standard closure', 'type': 'PROCEDURE', 'description': 'Standard closure technique of the port site from ecternal', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohie El-Din M Madany, MD', 'role': 'CONTACT', 'email': 'Mohie.madany@med.aswu.edu.eg', 'phone': '01141341342'}, {'name': 'Mohie El-Din M Madany, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'Mohie El-Din M Madani, MD', 'role': 'CONTACT', 'email': 'Mohie.madany@med.aswu.edu.eg', 'phone': '01141341342'}, {'name': 'Emad R Issak, MSc', 'role': 'CONTACT', 'email': 'emangate@gmail.com', 'phone': '01066208065'}], 'overallOfficials': [{'name': 'Mohie El-Din M Madani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ClinAmygate', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aswan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}