The Effect of the Covid-19 Pandemic Among Operated Patients

Recruiting

• Conditions: Covid19; Surgery
• Interventions: Other: COVID-19 infection status

• Registration Number: NCT04525716
• Lead Sponsor: Karolinska Institutet

Brief Summary

This project covers several research aims. In a cohort study, the investigators aim to compare confirmed COVID-19 patients with non-COVID-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.

Detailed Description

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-22
• Study First Posted: 2020-08-25
• Primary Completion: 2022-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19	COVID-19 infection status	Patients with confirmed COVID-19 infection
Non-COVID-19	COVID-19 infection status	Patients without confirmed COVID-19 infection

Primary Outcome Measures

Name	Time	Method
Death	30 days post surgery	Mortality

Secondary Outcome Measures

Name	Time	Method
Complications	3 months post surgery	Includes readmission, reoperation, infection, sepsis, respiratory failure, and number of days in the intensive care unit
Length of stay	Through study completion, an average of 1 month	Length of hospital stay

Trial Locations

Locations (1)

Samtliga akutsjukhus i Region Stockholm; 🇸🇪 Stockholm, Sweden