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NCT Number: NCT04684433

Surgery in the Time of COVID-19 Pandemic

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. Surgery code

    Time frame: 5 minutes

    Type of surgery as defined by the surgery code

  2. Urgency

    Time frame: 5 minutes

    Degree of urgency of the surgery

  3. Type of anesthesia

    Time frame: 5 minutes

    Type of anesthesia

  4. Delay between surgery and first symptoms

    Time frame: 5 minutes

    Delay between surgery and first symptoms

  5. Surgery duration

    Time frame: 5 minutes

    Surgery duration (anesthesia included)

  6. Hospital stay (in days)

    Time frame: 5 minutes

    Hospital stay (in days)

  7. Intensive care unit stay (in days)

    Time frame: 5 minutes

    Intensive care unit stay (in days)

  8. Post-op complications

    Time frame: 5 minutes

    Post-op complications

  9. Covid status before surgery

    Time frame: 5 minutes

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

  10. Covid status post-surgery

    Time frame: 5 minutes

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

  11. COVID19 Diagnosis by CT scan

    Time frame: 5 minutes

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

  12. COVID19 Diagnosis by swab test

    Time frame: 5 minutes

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

  13. COVID 19 Diagnosis by antibody test

    Time frame: 5 minutes

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

  14. COVID19 symptoms - dry cough

    Time frame: 5 minutes

    dry cough (Yes=1, No=0)

  15. COVID19 symptoms - fever

    Time frame: 5 minutes

    fever (Yes=1, No=0)

  16. COVID19 symptoms - myalgia

    Time frame: 5 minutes

    myalgia (Yes=1, No=0)

  17. COVID19 symptoms - anosmia

    Time frame: 5 minutes

    anosmia (Yes=1, No=0)

  18. COVID19 symptoms -respiratory distress

    Time frame: 5 minutes

    respiratory distress (Yes=1, No=0)

  19. Treatment for COVID19 - Plaquenil

    Time frame: 5 minutes

    Plaquenil (Yes=1, No=0)

  20. Treatment for COVID19 - Antivirals

    Time frame: 5 minutes

    Antivirals (Yes=1, No=0)

  21. Need for intubation

    Time frame: 5 minutes

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

  22. Death

    Time frame: 5 minutes

    Mortality (Yes=1, No=0)

Secondary outcomes

  1. Age

    Time frame: 5 minutes

    Patient age

  2. Gender

    Time frame: 5 minutes

    Patient gender

  3. Ethnicity

    Time frame: 5 minutes

    Patient ethnicity

  4. BMI

    Time frame: 5 minutes

    Patient Body Mass Index

  5. Comorbidities

    Time frame: 5 minutes

    Patient comorbidities

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2020
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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