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NCT Number: NCT04525716

The Effect of the Covid-19 Pandemic Among Operated Patients

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

All acute care hospitals in Region Stockholm

Stockholm, Sweden

Location status: Recruiting

Location contact

Andreas Älgå, MD, PhD

CONTACT

[email protected]

0702463287

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

COVID-19 infection status

Other

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

Socioeconomic status

Other

Patients from different socioeconomic groups will be compared

Primary outcomes

  1. Death

    Time frame: 30 days post surgery

    Mortality

Secondary outcomes

  1. Length of stay

    Time frame: Through study completion, an average of 1 month

    Length of hospital stay

  2. Complications

    Time frame: 3 months post surgery

    Includes readmission, reoperation, infection, sepsis, respiratory failure, and number of days in the intensive care unit

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Älgå, MD, PhD

CONTACT

[email protected]

0702463287

Martin Nordberg, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

What Are the Effects of the Covid-19 Pandemic Among Operated Patients? A Hospital Based Cohort in Stockholm, Sweden

Important dates

Study start
2020
Primary completion
2027
Study completion
2029
First posted
Aug 25, 2020
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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