The Effect of the Covid-19 Pandemic Among Operated Patients
NCT ID: NCT04525716
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300000 participants
OBSERVATIONAL
2020-01-01
2029-12-31
Brief Summary
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Detailed Description
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A novel Coronavirus (SARS-CoV-2) was first detected in the Hubei Province in China in December, 2019. The virus causes a severe respiratory disease (Coronavirus disease 2019, COVID-19) that has rapidly spread worldwide. The COVID-19 pandemic is prognosed to affect a majority of the world's population before the end of 2020. Throughout the course of the pandemic, patients will continuously need essential healthcare, such as for acute surgical conditions. How the clinical course and management of surgical conditions is influenced by concomitant COVID-19 is largely unknown. There is an acute need for an improved evidence base to inform treatment strategies and guide the management of this patient group.
Objectives of initial analyses:
1\. To compare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.
Methods:
The study will enroll consecutive patients that undergo surgical treatment in the Stockholm Region. Data will be extracted from a series of linked electronic systems, such as electronic healthcare records systems, and regional data systems. Collected data will include routine clinical data, such as baseline characteristics, previous medical history, details on care given at the hospital and data from follow-up visits. Endpoints include death, length of hospital stay and complications, such as readmission, reoperation, sepsis, respiratory failure, and number of days in the intensive care unit. Outcome data of patients with confirmed COVID-19 will be compared to those of patients without COVID-19.
Objectives and methods of further analyses:
By comparing surgical patients from different socioeconomic groups the investigators aim to assess whether socioeconomic status is associated with good or bad outcomes.
Dissemination and relevance:
To the best of the investigators knowledge, there has been no previous comprehensive comparative research on patients with and without confirmed COVID-19 that undergo surgical treatment.
The results will be disseminated through peer-reviewed publications, aiming for journals with a rapid editorial process, preferably open access journals. The findings are expected to increase the knowledge to establish best-treatment strategies and improve outcomes, both for patients affected by COVID-19 and by future epidemics.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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COVID-19
Patients with confirmed COVID-19 infection
COVID-19 infection status
The investigators will compare patients with/without confirmed COVID-19 infection
Non-COVID-19
Patients without confirmed COVID-19 infection
COVID-19 infection status
The investigators will compare patients with/without confirmed COVID-19 infection
Socioeconomic status
Patients with varying socioeconomic status will be compared
Socioeconomic status
Patients from different socioeconomic groups will be compared
Interventions
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COVID-19 infection status
The investigators will compare patients with/without confirmed COVID-19 infection
Socioeconomic status
Patients from different socioeconomic groups will be compared
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Andreas Älgå
MD, PhD
Principal Investigators
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Martin Nordberg, MD, PhD
Role: STUDY_CHAIR
Karolinska Institutet, Södersjukhuset
Locations
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All acute care hospitals in Region Stockholm
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CovidKirurgi
Identifier Type: -
Identifier Source: org_study_id
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