Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 1:24 PM
Study NCT ID:
NCT05770128
Status:
UNKNOWN
Last Update Posted:
2023-03-15
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subserosal Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020706', 'term': 'Laparoscopes'}], 'ancestors': [{'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique.', 'timeFrame': '6 months', 'description': 'incidence of bleeding after subserosal laparoscopic cholecystectomy in comparison to conventional technique.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholecystitis']}, 'descriptionModule': {'briefSummary': 'The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'any patient admitted to surgical department wth age above 18 years old suffering \\& diagnosed of chronic cholecystitis , symptomatic cholelithiasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with age of or above 18 years.\n* Diagnosis of chronic cholecystitis , symptomatic cholelithiasis\n\nExclusion Criteria:\n\n* Previous operation or adhesion\n* severe Acute Calculus pancreatitis\n* gall bladder cancer\n* Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)\n* Recurrent cases'}, 'identificationModule': {'nctId': 'NCT05770128', 'briefTitle': 'Subserosal Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Subserosal Laparoscopic Cholecystectomy for Safe Gall Bladder Surgery', 'orgStudyIdInfo': {'id': 'cholecystectomy by laparoscpe'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laparoscope', 'type': 'PROCEDURE', 'description': 'subserosal manipulation of gallbladder with laparoscope .'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed M. Hussein, resident', 'role': 'CONTACT', 'email': 'ahmed.s7s1929@gmail.com', 'phone': '+201010729020'}, {'name': 'Abdallah B. Abdallah, professor', 'role': 'CONTACT', 'email': 'badawy@aun.edu.eg', 'phone': '+201000002283'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ahmed Mohamed Hussein', 'investigatorFullName': 'Ahmed Mohammed Hussein Ali', 'investigatorAffiliation': 'Assiut University'}}}}