Clinical trial NCT04525716: The Effect of the Covid-19 Pandemic Among Operated Patients
Official title: What Are the Effects of the Covid-19 Pandemic Among Operated Patients? A Hospital Based Cohort in Stockholm, Sweden
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Surgery
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that undergo surgical treatment in the Stockholm Region during the study period

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Death
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Length of stay
timeFrame: Through study completion, an average of 1 month
measure: Complications
timeFrame: 3 months post surgery
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Samtliga akutsjukhus i Region Stockholm
Study officials:
affiliation: Södersjukhuset AB, Stockholm, Sweden
name: Gabriel Sandblom, MD, PhD
role: STUDY_CHAIR
References: