Surgery in the Time of COVID-19 Pandemic

March 15, 2021 updated by: Pierre Wauthy, Brugmann University Hospital

The ongoing coronavirus disease 2019 (COVID-19) which started in China, was declared on the 11th of March as a global pandemic 2020 by the World Health Organization (WHO).

Governments around the world have introduced differing forms of lock downs since the start of the pandemic demanding citizens to confine to their homes and go out only in necessity to minimize exposure to the virus. The response was observed in the emergency departments and the number of patients who presented for non-Covid issues drastically reduced.

Hospitals activated their mass casualty management plans and have reorganized and overstretched their capacity to be able to absorb both the influx of patients with the virus and those with other conditions.

Part of that reorganization was reducing the surgical activity. The main focus was shifted to patients who are considered urgent and elective surgery were postponed. Hence only surgical emergencies were maintained. Many did not present to the emergency department for fear to contract the virus and from a sense of national and global solidarity against that pandemic.

Whereas these measures are essential to prevent the spread of the virus, it may be hypothesized that for non-Covid issues, including surgical emergencies, patients may present late to the emergency department due to fear of contracting the infection in hospital. This would delay their management and lead to a worsened symptomology on presentation requiring a more complex surgical intervention with an increased complication profile.

The investigators present initial data from four major hospitals in Belgium, characterizing surgical emergencies that were managed since the start of the pandemic and discuss the repercussion the pandemic has on management of urgent surgical patients and most likely evolution of surgery after the pandemic.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

707

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussel, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1020
        • CHU Brugmann
      • Brussels, Belgium, 1070
        • Erasme
      • Brussels, Belgium, 1000
        • St Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patient that have benefited of a surgical intervention since the start of the COVID19 pandemic in Belgium and specifically the 16 th of March 2020 (lock down) to 12 of april 2020. The involved hospitals are: Brugmann hospital, UZ Brussel Hospital, Erasme Hospital and Saint Pierre Hospital.

Description

Inclusion Criteria:

Patients who had a surgical procedure since the start of the lock down in Belgium due to the COVID19 pandemic (16 of March 2020 to the 12 of April 2020).

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical intervention
Patients who had a surgical procedure since the start of the lockdown in Belgium due to the COVID19 pandemic (16 of March 2020 to the 12 of April 2020.
Data extraction from medical files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery code
Time Frame: 5 minutes
Type of surgery as defined by the surgery code
5 minutes
Urgency
Time Frame: 5 minutes
Degree of urgency of the surgery
5 minutes
Type of anesthesia
Time Frame: 5 minutes
Type of anesthesia
5 minutes
Delay between surgery and first symptoms
Time Frame: 5 minutes
Delay between surgery and first symptoms
5 minutes
Surgery duration
Time Frame: 5 minutes
Surgery duration (anesthesia included)
5 minutes
Hospital stay (in days)
Time Frame: 5 minutes
Hospital stay (in days)
5 minutes
Intensive care unit stay (in days)
Time Frame: 5 minutes
Intensive care unit stay (in days)
5 minutes
Post-op complications
Time Frame: 5 minutes
Post-op complications
5 minutes
Covid status before surgery
Time Frame: 5 minutes
Covid status before surgery (positive=1, negative=0 )
5 minutes
Covid status post-surgery
Time Frame: 5 minutes
Covid status post-op (positive=1, negative=0 )
5 minutes
COVID19 Diagnosis by CT scan
Time Frame: 5 minutes
COVID19 Diagnosis confirmed by CT scan of the thorax (Yes=1, No=0)
5 minutes
COVID19 Diagnosis by swab test
Time Frame: 5 minutes
COVID19 Diagnosis by swab test (Yes=1, No=0)
5 minutes
COVID 19 Diagnosis by antibody test
Time Frame: 5 minutes
COVID 19 Diagnosis by antibody test (Yes=1, No=0)
5 minutes
COVID19 symptoms - dry cough
Time Frame: 5 minutes
dry cough (Yes=1, No=0)
5 minutes
COVID19 symptoms - fever
Time Frame: 5 minutes
fever (Yes=1, No=0)
5 minutes
COVID19 symptoms - myalgia
Time Frame: 5 minutes
myalgia (Yes=1, No=0)
5 minutes
COVID19 symptoms - anosmia
Time Frame: 5 minutes
anosmia (Yes=1, No=0)
5 minutes
COVID19 symptoms -respiratory distress
Time Frame: 5 minutes
respiratory distress (Yes=1, No=0)
5 minutes
Treatment for COVID19 - Plaquenil
Time Frame: 5 minutes
Plaquenil (Yes=1, No=0)
5 minutes
Treatment for COVID19 - Antivirals
Time Frame: 5 minutes
Antivirals (Yes=1, No=0)
5 minutes
Need for intubation
Time Frame: 5 minutes
Need for intubation (Yes=1, No=0)
5 minutes
Death
Time Frame: 5 minutes
Mortality (Yes=1, No=0)
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 5 minutes
Patient age
5 minutes
Gender
Time Frame: 5 minutes
Patient gender
5 minutes
Ethnicity
Time Frame: 5 minutes
Patient ethnicity
5 minutes
BMI
Time Frame: 5 minutes
Patient Body Mass Index
5 minutes
Comorbidities
Time Frame: 5 minutes
Patient comorbidities
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yasser Farid, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 14, 2020

Primary Completion (ACTUAL)

March 15, 2021

Study Completion (ACTUAL)

March 15, 2021

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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