Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:58 AM
Study NCT ID:
NCT05197660
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'observed and expected number', 'timeFrame': '2020 and first half of 2021'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Cataract', 'Hip Arthroplasty', 'Knee Arthroplasty', 'Coronary Stent', 'Pacemaker', 'COVID-19 Pandemic']}, 'descriptionModule': {'briefSummary': 'Determine the consequences of COVID-19 pandemic on routine targeted surgeries.\n\nFive surgical procedures were considered : cataract surgery, hip and knee arthoplasties, coronary revascularisation by angioplasty and definitive cardiac stimulation.\n\nThe objective of the study is to quantify changes of these procedures in 2020 and in 2021 (up to June) compared to 2019 taking into account their annual evolution and according to the type of operation (primary or reoperation/revision) and emergency status, if applicable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All hospitalizations with at least one act of each surgery between January 1, 2019, and June 30, 2021 from the French National Health Data System (SNDS).\n\nThe National Health Data System (SNDS) is a set of strictly anonymous databases, comprising all mandatory national health insurance reimbursement data, particularly data derived from processing of health care claims (electronic or paper claims) and data from health care facilities (PMSI).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalizations with at least one act of cataract surgey hip arthroplasty knee arthroplasty coronary angioplasty definitive cardiac stimulation (pacemaker)\n* between January 1, 2019, and June 30, 2021\n\nExclusion Criteria:\n\n-hospitalizations for personal identifier problems in the database'}, 'identificationModule': {'nctId': 'NCT05197660', 'briefTitle': 'Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'EPI-PHARE'}, 'officialTitle': 'Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study', 'orgStudyIdInfo': {'id': 'EP-0275'}}, 'armsInterventionsModule': {'armGroups': [{'label': '- cataract surgery', 'interventionNames': ['Procedure: surgical procedures']}, {'label': '- hip arthoplasty', 'interventionNames': ['Procedure: surgical procedures']}, {'label': '- knee arthoplasty', 'interventionNames': ['Procedure: surgical procedures']}, {'label': '- coronary angioplasty', 'interventionNames': ['Procedure: surgical procedures']}, {'label': '- definitive cardiac stimulation (pacemaker)', 'interventionNames': ['Procedure: surgical procedures']}], 'interventions': [{'name': 'surgical procedures', 'type': 'PROCEDURE', 'description': 'number of hospital stays', 'armGroupLabels': ['- cataract surgery', '- coronary angioplasty', '- definitive cardiac stimulation (pacemaker)', '- hip arthoplasty', '- knee arthoplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93 285', 'city': 'Saint-Denis', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'E Dufour', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}], 'overallOfficials': [{'name': 'Mahmoud Zureik', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EPI-PHARE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EPI-PHARE', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pharmacoepidemiologist, French National Agency for Medicines and Health Products Safety, French National Health Insurance', 'investigatorFullName': 'Emmanuelle Dufour', 'investigatorAffiliation': 'EPI-PHARE'}}}}