Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 12:05 AM
Study NCT ID:
NCT04684433
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2020-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery in the Time of COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 707}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgery code', 'timeFrame': '5 minutes', 'description': 'Type of surgery as defined by the surgery code'}, {'measure': 'Urgency', 'timeFrame': '5 minutes', 'description': 'Degree of urgency of the surgery'}, {'measure': 'Type of anesthesia', 'timeFrame': '5 minutes', 'description': 'Type of anesthesia'}, {'measure': 'Delay between surgery and first symptoms', 'timeFrame': '5 minutes', 'description': 'Delay between surgery and first symptoms'}, {'measure': 'Surgery duration', 'timeFrame': '5 minutes', 'description': 'Surgery duration (anesthesia included)'}, {'measure': 'Hospital stay (in days)', 'timeFrame': '5 minutes', 'description': 'Hospital stay (in days)'}, {'measure': 'Intensive care unit stay (in days)', 'timeFrame': '5 minutes', 'description': 'Intensive care unit stay (in days)'}, {'measure': 'Post-op complications', 'timeFrame': '5 minutes', 'description': 'Post-op complications'}, {'measure': 'Covid status before surgery', 'timeFrame': '5 minutes', 'description': 'Covid status before surgery (positive=1, negative=0 )'}, {'measure': 'Covid status post-surgery', 'timeFrame': '5 minutes', 'description': 'Covid status post-op (positive=1, negative=0 )'}, {'measure': 'COVID19 Diagnosis by CT scan', 'timeFrame': '5 minutes', 'description': 'COVID19 Diagnosis confirmed by CT scan of the thorax (Yes=1, No=0)'}, {'measure': 'COVID19 Diagnosis by swab test', 'timeFrame': '5 minutes', 'description': 'COVID19 Diagnosis by swab test (Yes=1, No=0)'}, {'measure': 'COVID 19 Diagnosis by antibody test', 'timeFrame': '5 minutes', 'description': 'COVID 19 Diagnosis by antibody test (Yes=1, No=0)'}, {'measure': 'COVID19 symptoms - dry cough', 'timeFrame': '5 minutes', 'description': 'dry cough (Yes=1, No=0)'}, {'measure': 'COVID19 symptoms - fever', 'timeFrame': '5 minutes', 'description': 'fever (Yes=1, No=0)'}, {'measure': 'COVID19 symptoms - myalgia', 'timeFrame': '5 minutes', 'description': 'myalgia (Yes=1, No=0)'}, {'measure': 'COVID19 symptoms - anosmia', 'timeFrame': '5 minutes', 'description': 'anosmia (Yes=1, No=0)'}, {'measure': 'COVID19 symptoms -respiratory distress', 'timeFrame': '5 minutes', 'description': 'respiratory distress (Yes=1, No=0)'}, {'measure': 'Treatment for COVID19 - Plaquenil', 'timeFrame': '5 minutes', 'description': 'Plaquenil (Yes=1, No=0)'}, {'measure': 'Treatment for COVID19 - Antivirals', 'timeFrame': '5 minutes', 'description': 'Antivirals (Yes=1, No=0)'}, {'measure': 'Need for intubation', 'timeFrame': '5 minutes', 'description': 'Need for intubation (Yes=1, No=0)'}, {'measure': 'Death', 'timeFrame': '5 minutes', 'description': 'Mortality (Yes=1, No=0)'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': '5 minutes', 'description': 'Patient age'}, {'measure': 'Gender', 'timeFrame': '5 minutes', 'description': 'Patient gender'}, {'measure': 'Ethnicity', 'timeFrame': '5 minutes', 'description': 'Patient ethnicity'}, {'measure': 'BMI', 'timeFrame': '5 minutes', 'description': 'Patient Body Mass Index'}, {'measure': 'Comorbidities', 'timeFrame': '5 minutes', 'description': 'Patient comorbidities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The ongoing coronavirus disease 2019 (COVID-19) which started in China, was declared on the 11th of March as a global pandemic 2020 by the World Health Organization (WHO).\n\nGovernments around the world have introduced differing forms of lock downs since the start of the pandemic demanding citizens to confine to their homes and go out only in necessity to minimize exposure to the virus. The response was observed in the emergency departments and the number of patients who presented for non-Covid issues drastically reduced.\n\nHospitals activated their mass casualty management plans and have reorganized and overstretched their capacity to be able to absorb both the influx of patients with the virus and those with other conditions.\n\nPart of that reorganization was reducing the surgical activity. The main focus was shifted to patients who are considered urgent and elective surgery were postponed. Hence only surgical emergencies were maintained. Many did not present to the emergency department for fear to contract the virus and from a sense of national and global solidarity against that pandemic.\n\nWhereas these measures are essential to prevent the spread of the virus, it may be hypothesized that for non-Covid issues, including surgical emergencies, patients may present late to the emergency department due to fear of contracting the infection in hospital. This would delay their management and lead to a worsened symptomology on presentation requiring a more complex surgical intervention with an increased complication profile.\n\nThe investigators present initial data from four major hospitals in Belgium, characterizing surgical emergencies that were managed since the start of the pandemic and discuss the repercussion the pandemic has on management of urgent surgical patients and most likely evolution of surgery after the pandemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patient that have benefited of a surgical intervention since the start of the COVID19 pandemic in Belgium and specifically the 16 th of March 2020 (lock down) to 12 of april 2020. The involved hospitals are: Brugmann hospital, UZ Brussel Hospital, Erasme Hospital and Saint Pierre Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who had a surgical procedure since the start of the lock down in Belgium due to the COVID19 pandemic (16 of March 2020 to the 12 of April 2020).\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT04684433', 'briefTitle': 'Surgery in the Time of COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Surgery in the Time of COVID-19 Pandemic', 'orgStudyIdInfo': {'id': 'CHUB-Farid'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical intervention', 'description': 'Patients who had a surgical procedure since the start of the lockdown in Belgium due to the COVID19 pandemic (16 of March 2020 to the 12 of April 2020.', 'interventionNames': ['Other: Data extraction from medical files']}], 'interventions': [{'name': 'Data extraction from medical files', 'type': 'OTHER', 'description': 'Data extraction from medical files', 'armGroupLabels': ['Surgical intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'St Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Yasser Farid', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Pierre Wauthy', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}