The Effect of the Covid-19 Pandemic Among Operated Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Surgery
• Intervention / Treatment: Other: COVID-19 infection status

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Andreas Älgå, MD, PhD; Phone Number: 0702463287; Email: andreas.alga@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Samtliga akutsjukhus i Region Stockholm
    • Contact: Andreas Älgå, MD, PhD; Phone Number: 0702463287; Email: andreas.alga@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; Patients with confirmed COVID-19 infection	Other: COVID-19 infection status; We will compare patients with/without confirmed COVID-19 infection
Non-COVID-19; Patients without confirmed COVID-19 infection	Other: COVID-19 infection status; We will compare patients with/without confirmed COVID-19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Mortality	30 days post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Chair: Gabriel Sandblom, MD, PhD, Södersjukhuset AB, Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CovidKirurgi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No