The Effect of the Covid-19 Pandemic Among Operated Patients

NCT ID: NCT04525716

Last Updated: 2025-11-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2029-12-31

Brief Summary

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This project covers several research aims and uses different research methods, such as cohort analyses.

Detailed Description

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Background:

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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Covid19 Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19

Patients with confirmed COVID-19 infection

COVID-19 infection status

Intervention Type OTHER

The investigators will compare patients with/without confirmed COVID-19 infection

Non-COVID-19

Patients without confirmed COVID-19 infection

COVID-19 infection status

Intervention Type OTHER

The investigators will compare patients with/without confirmed COVID-19 infection

Socioeconomic status

Patients with varying socioeconomic status will be compared

Socioeconomic status

Intervention Type OTHER

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

Intervention Type OTHER

Socioeconomic status

Patients from different socioeconomic groups will be compared

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients that undergo surgical treatment in the Stockholm Region during the study period

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Andreas Älgå

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Andreas Älgå, MD, PhD

Role: CONTACT

0702463287

Martin Nordberg, MD, PhD

Role: CONTACT

Facility Contacts

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Andreas Älgå, MD, PhD

Role: primary

0702463287

Other Identifiers

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CovidKirurgi

Identifier Type: -

Identifier Source: org_study_id

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