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Clinical Trials/NCT04684433
NCT04684433
Completed
Not Applicable

Surgery in the Time of COVID-19 Pandemic

Brugmann University Hospital4 sites in 1 country707 target enrollmentApril 14, 2020
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Brugmann University Hospital
Enrollment
707
Locations
4
Primary Endpoint
Intensive care unit stay (in days)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 14, 2020
End Date
March 15, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pierre Wauthy

Medical Director

Brugmann University Hospital

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Intensive care unit stay (in days)

Time Frame: 5 minutes

Intensive care unit stay (in days)

Surgery code

Time Frame: 5 minutes

Type of surgery as defined by the surgery code

Delay between surgery and first symptoms

Time Frame: 5 minutes

Delay between surgery and first symptoms

Surgery duration

Time Frame: 5 minutes

Surgery duration (anesthesia included)

Covid status post-surgery

Time Frame: 5 minutes

Covid status post-op (positive=1, negative=0 )

COVID19 Diagnosis by CT scan

Time Frame: 5 minutes

COVID19 Diagnosis confirmed by CT scan of the thorax (Yes=1, No=0)

COVID19 symptoms - myalgia

Time Frame: 5 minutes

myalgia (Yes=1, No=0)

COVID19 symptoms -respiratory distress

Time Frame: 5 minutes

respiratory distress (Yes=1, No=0)

Treatment for COVID19 - Plaquenil

Time Frame: 5 minutes

Plaquenil (Yes=1, No=0)

Covid status before surgery

Time Frame: 5 minutes

Covid status before surgery (positive=1, negative=0 )

COVID19 Diagnosis by swab test

Time Frame: 5 minutes

COVID19 Diagnosis by swab test (Yes=1, No=0)

Treatment for COVID19 - Antivirals

Time Frame: 5 minutes

Antivirals (Yes=1, No=0)

Need for intubation

Time Frame: 5 minutes

Need for intubation (Yes=1, No=0)

Death

Time Frame: 5 minutes

Mortality (Yes=1, No=0)

Urgency

Time Frame: 5 minutes

Degree of urgency of the surgery

COVID19 symptoms - dry cough

Time Frame: 5 minutes

dry cough (Yes=1, No=0)

COVID19 symptoms - fever

Time Frame: 5 minutes

fever (Yes=1, No=0)

COVID19 symptoms - anosmia

Time Frame: 5 minutes

anosmia (Yes=1, No=0)

Post-op complications

Time Frame: 5 minutes

Post-op complications

COVID 19 Diagnosis by antibody test

Time Frame: 5 minutes

COVID 19 Diagnosis by antibody test (Yes=1, No=0)

Type of anesthesia

Time Frame: 5 minutes

Type of anesthesia

Hospital stay (in days)

Time Frame: 5 minutes

Hospital stay (in days)

Secondary Outcomes

  • Gender(5 minutes)
  • Age(5 minutes)
  • BMI(5 minutes)
  • Ethnicity(5 minutes)
  • Comorbidities(5 minutes)

Study Sites (4)

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