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Recruiting NCT04525716

The Effect of the Covid-19 Pandemic Among Operated Patients

Observational Covid19 Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: COVID-19 infection status, Socioeconomic status.
Who it may be relevant to
Registry conditions: Covid19, Surgery. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

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.

Interventions

  • Other COVID-19 infection status
    The investigators will compare patients with/without confirmed COVID-19 infection
  • Other Socioeconomic status
    Patients from different socioeconomic groups will be compared

Primary outcome measures

  • Death [Time frame: 30 days post surgery]
Secondary outcome measures (2)
  • Length of stay [Time frame: Through study completion, an average of 1 month]
  • Complications [Time frame: 3 months post surgery]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • All acute care hospitals in Region Stockholm — Stockholm

Identifiers

NCT: NCT04525716 · CovidKirurgi

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗