Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04482205
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2020-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086522', 'term': 'Financial Stress'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effect of Covid -19 on the total costs of inpatient care', 'timeFrame': '5 months', 'description': 'the effect of Covid -19 on the total costs of inpatient care during Covid era'}], 'secondaryOutcomes': [{'measure': 'drop in the collective revenue generated in covid era', 'timeFrame': '5 months', 'description': 'to quantify drop in the collective revenue generated in covid era'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['economic burden, covid-19 pandemic'], 'conditions': ['Economic Burden']}, 'descriptionModule': {'briefSummary': 'Covid-19 has adversely impacted the health care organizations by over burdening with Covid patients and suspending the elective surgeries and clinics A single center retrospective study was conducted to quantify losses due to postponement of elective surgeries and extra cost for procurement of PPEs. The secondary objective was to see the effect of Covid -19 on the total costs of inpatient care during Covid era.', 'detailedDescription': 'Covid-19 has impacted adversely the economy of Pakistan that has already poor and challenged socioeconomic conditions This is a single hospital retrospective cross sectional study conducted to quantify losses due postponement of elective surgeries and procurement of PPEs and see the effect of Covid -19 on the total costs of inpatient care during Covid era.\n\nWe included all the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020. We divided this period into two halves; the first half was from January first to March 15 named as PreCovid Era and second half was from March 16, to May 31, 2020, termed as Covid Era. The total number of trauma procedures and elective procedures were compared in both eras. We compared six procedures each from upper and lower limit for cost analysis and length of stay. We also analyzed the extra cost for procurement of PPEs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted for operative intervention of fractures management and elective procedures for tumour, degenerative disease, sport related injuries', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients admitted in orthopedic section for operative intervention of fractures and elective procedures from January 1, 2020 to May 31, 2020.\n\nExclusion Criteria:\n\n* Patients presenting with other bone morbidities that did not require surgical interventions including rickets, osteomalacia, osteogenesis imperfecta, marble bone disease (osteopetrosis), Paget disease of bone, and fibrous dysplasia, patients with incomplete medical records were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04482205', 'briefTitle': 'Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Covid -19 Pandemic: Economic Burden on Patients Operated for Traumatic Close Fractures in Musculoskeletal Service Line of a Tertiary Care Hospital', 'orgStudyIdInfo': {'id': 'akupde'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'precovid group', 'description': 'those who were operated from fJanuary first to March 15'}, {'label': 'covid', 'description': 'those operated from March 16, to May 31, 2020'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aga Khan University Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Pervaiz Hashmi, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'shah fahad', 'investigatorAffiliation': 'Aga Khan University'}}}}