Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 5:22 AM
Study NCT ID:
NCT05979233
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2023-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Session Vs Staged Management of Calcular Obstructive Jaundice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-07-30', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total cost', 'timeFrame': '6 months', 'description': 'total cost in Egyptian pound'}, {'measure': 'hospital stay', 'timeFrame': '6 months', 'description': 'total hospital stay in days'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': '30 days', 'description': 'early postoperative complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Calcular Obstructive Jaundice', 'Gall Bladder Disease']}, 'descriptionModule': {'briefSummary': 'to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management', 'detailedDescription': 'to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 18-70 year\n* combined CBD and gall stone\n* stone less than 1.5 cm\n* fit for surgery\n* no upper abdominal surgery\n\nExclusion Criteria:\n\n* age \\<18 and \\>70\n* unfit for surgery\n* stone more than 1.5 cm\n* upper abdominal surgery'}, 'identificationModule': {'nctId': 'NCT05979233', 'briefTitle': 'One Session Vs Staged Management of Calcular Obstructive Jaundice', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'One Session Vs Staged Laropendoscopic Management of Calcular Obstructive Jaundice', 'orgStudyIdInfo': {'id': 'fac.med.23.42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'staged managment', 'description': 'ERCP then interval laparoscopic cholecystectomy', 'interventionNames': ['Procedure: staged managment']}, {'type': 'EXPERIMENTAL', 'label': 'one session ERCP then LC', 'description': 'one session ERCP then LC', 'interventionNames': ['Procedure: one session ERCP then LC']}, {'type': 'EXPERIMENTAL', 'label': 'one session LC then ERCP', 'description': 'one session LC then ERCP', 'interventionNames': ['Procedure: one session LC then ERCP']}], 'interventions': [{'name': 'staged managment', 'type': 'PROCEDURE', 'description': 'staged management', 'armGroupLabels': ['staged managment']}, {'name': 'one session ERCP then LC', 'type': 'PROCEDURE', 'description': 'one session ERCP then LC', 'armGroupLabels': ['one session ERCP then LC']}, {'name': 'one session LC then ERCP', 'type': 'PROCEDURE', 'description': 'one session LC then ERCP', 'armGroupLabels': ['one session LC then ERCP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alaa M Sewefy, MD', 'role': 'CONTACT', 'email': 'sewafy@yahoo.co.uk', 'phone': '+201006448805'}, {'name': 'M', 'role': 'CONTACT'}], 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, professor & consultant of general surgery, Department of surgery, Minia university hospital, Egypt', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}