Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-31 @ 3:18 PM
Study NCT ID:
NCT06873295
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2023-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Unit in Subjects Over and Under 75 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 424}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with an initial cold cholecystectomy strategy who did not undergo surgery, died or underwent emergency surgery', 'timeFrame': 'Up to 6 months, from date of first collection to date of end of collection', 'description': 'Percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Cholecystitis']}, 'descriptionModule': {'briefSummary': 'The management of these often frail elderly patients, with more comorbidities and declining functional capacities, is more complex and justifies a specific, tailored approach.\n\nAge is also associated with an increasing prevalence of gallstones. The disadvantages of "cold" surgery (longer hospital stay, higher cost, risk of disease recurrence in the interim, difficult surgery with more scar tissue due to repeated inflammation) have to be weighed against the high operative risk in the case of emergency surgery, leading to strict criteria for early cholecystectomy.\n\nThese criteria are rarely met in geriatric patients, who thus enter a hospital cycle whose impact on morbidity and mortality, as well as on loss of autonomy, has been demonstrated in this population. What\'s more, the deteriorating general condition of frail elderly patients means that a number of them end up being definitively rejected for surgery, despite an initial strategy of cold cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the digestive surgery department and geriatric perioperative unit of the CHU de Nîmes with a diagnosis of acute cholecystitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Diagnosis of acute cholecystitis.\n* Hospitalization in the digestive surgery department and geriatric perioperative unit of Nîmes University Hospital.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Opposition of the patient to his inclusion in the study after sending the letter of information and non-opposition.'}, 'identificationModule': {'nctId': 'NCT06873295', 'acronym': 'GERBILLE', 'briefTitle': 'Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Unit in Subjects Over and Under 75 Years', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of the Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Intraoperative Unit in Subjects Over and Under 75 Years of Age', 'orgStudyIdInfo': {'id': 'Local /2023'}}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'facility': 'Simonet Anne Clarisse', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}