Clinical trial NCT04684433: Surgery in the Time of COVID-19 Pandemic
Official title: Surgery in the Time of COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 707
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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:

None

Primary outcomes:
measure: Surgery code
timeFrame: 5 minutes
measure: Urgency
timeFrame: 5 minutes
measure: Type of anesthesia
timeFrame: 5 minutes
measure: Delay between surgery and first symptoms
timeFrame: 5 minutes
measure: Surgery duration
timeFrame: 5 minutes
measure: Hospital stay (in days)
timeFrame: 5 minutes
measure: Intensive care unit stay (in days)
timeFrame: 5 minutes
measure: Post-op complications
timeFrame: 5 minutes
measure: Covid status before surgery
timeFrame: 5 minutes
measure: Covid status post-surgery
timeFrame: 5 minutes
measure: COVID19 Diagnosis by CT scan
timeFrame: 5 minutes
measure: COVID19 Diagnosis by swab test
timeFrame: 5 minutes
measure: COVID 19 Diagnosis by antibody test
timeFrame: 5 minutes
measure: COVID19 symptoms - dry cough
timeFrame: 5 minutes
measure: COVID19 symptoms - fever
timeFrame: 5 minutes
measure: COVID19 symptoms - myalgia
timeFrame: 5 minutes
measure: COVID19 symptoms - anosmia
timeFrame: 5 minutes
measure: COVID19 symptoms -respiratory distress
timeFrame: 5 minutes
measure: Treatment for COVID19 - Plaquenil
timeFrame: 5 minutes
measure: Treatment for COVID19 - Antivirals
timeFrame: 5 minutes
measure: Need for intubation
timeFrame: 5 minutes
measure: Death
timeFrame: 5 minutes
Secondary outcomes:
measure: Age
timeFrame: 5 minutes
measure: Gender
timeFrame: 5 minutes
measure: Ethnicity
timeFrame: 5 minutes
measure: BMI
timeFrame: 5 minutes
measure: Comorbidities
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: St Pierre
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: Erasme
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: CHU Brugmann
name: Yasser Farid
role: STUDY_DIRECTOR
References: