Covid19NCT04684433
Surgery in the Time of COVID-19 Pandemic
An observational study of Covid19, run by Brugmann University Hospital at 4 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Data extraction from medical files
- How many people
- 707 participants
- Where
- 4 sitesBelgium
- Study dates
- 14 Apr 2020to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
St Pierre
Brussels, 1000
CHU Brugmann
Brussels, 1020
Erasme
Brussels, 1070
UZ Brussel
Brussels, 1090
About this study
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.
Read more
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.
- Conditions
- Covid19
- Being tested
- Data extraction from medical files
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery code
Type of surgery as defined by the surgery code
Measured: 5 minutes
Urgency
Degree of urgency of the surgery
Measured: 5 minutes
Type of anesthesia
Type of anesthesia
Measured: 5 minutes
Delay between surgery and first symptoms
Delay between surgery and first symptoms
Measured: 5 minutes
Surgery duration
Surgery duration (anesthesia included)
Measured: 5 minutes
Hospital stay (in days)
Hospital stay (in days)
Measured: 5 minutes
Intensive care unit stay (in days)
Intensive care unit stay (in days)
Measured: 5 minutes
Post-op complications
Post-op complications
Measured: 5 minutes
Covid status before surgery
Covid status before surgery (positive=1, negative=0 )
Measured: 5 minutes
Covid status post-surgery
Covid status post-op (positive=1, negative=0 )
Measured: 5 minutes
COVID19 Diagnosis by CT scan
COVID19 Diagnosis confirmed by CT scan of the thorax (Yes=1, No=0)
Measured: 5 minutes
COVID19 Diagnosis by swab test
COVID19 Diagnosis by swab test (Yes=1, No=0)
Measured: 5 minutes
COVID 19 Diagnosis by antibody test
COVID 19 Diagnosis by antibody test (Yes=1, No=0)
Measured: 5 minutes
COVID19 symptoms - dry cough
dry cough (Yes=1, No=0)
Measured: 5 minutes
COVID19 symptoms - fever
fever (Yes=1, No=0)
Measured: 5 minutes
COVID19 symptoms - myalgia
myalgia (Yes=1, No=0)
Measured: 5 minutes
COVID19 symptoms - anosmia
anosmia (Yes=1, No=0)
Measured: 5 minutes
COVID19 symptoms -respiratory distress
respiratory distress (Yes=1, No=0)
Measured: 5 minutes
Treatment for COVID19 - Plaquenil
Plaquenil (Yes=1, No=0)
Measured: 5 minutes
Treatment for COVID19 - Antivirals
Antivirals (Yes=1, No=0)
Measured: 5 minutes
Need for intubation
Need for intubation (Yes=1, No=0)
Measured: 5 minutes
Death
Mortality (Yes=1, No=0)
Measured: 5 minutes
Secondary outcomes (5)
Age
Patient age
Measured: 5 minutes
Gender
Patient gender
Measured: 5 minutes
Ethnicity
Patient ethnicity
Measured: 5 minutes
BMI
Patient Body Mass Index
Measured: 5 minutes
Comorbidities
Patient comorbidities
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start14 Apr 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Wauthy, Brugmann University Hospital
- Investigators
- Yasser Farid, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684433
- Sponsor's protocol ID
- CHUB-Farid
- Status last verified
- Mar 2021
- First submitted
- 23 Dec 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery in the Time of COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04684433
- Acronym / sponsor ID
- CHUB-Farid
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention | – | Other: Data extraction from medical filesPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | Surgical intervention |
Primary outcome
Surgery code
Time frame: 5 minutes
Type of surgery as defined by the surgery code
Urgency
Time frame: 5 minutes
Degree of urgency of the surgery
Type of anesthesia
Time frame: 5 minutes
Type of anesthesia
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)
Hospital stay (in days)
Time frame: 5 minutes
Hospital stay (in days)
Intensive care unit stay (in days)
Time frame: 5 minutes
Intensive care unit stay (in days)
Post-op complications
Time frame: 5 minutes
Post-op complications
Covid status before surgery
Time frame: 5 minutes
Covid status before surgery (positive=1, negative=0 )
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 Diagnosis by swab test
Time frame: 5 minutes
COVID19 Diagnosis by swab test (Yes=1, No=0)
COVID 19 Diagnosis by antibody test
Time frame: 5 minutes
COVID 19 Diagnosis by antibody test (Yes=1, No=0)
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 - myalgia
Time frame: 5 minutes
myalgia (Yes=1, No=0)
COVID19 symptoms - anosmia
Time frame: 5 minutes
anosmia (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)
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)
5 secondary outcomes
Age
Time frame: 5 minutes
Gender
Time frame: 5 minutes
Ethnicity
Time frame: 5 minutes
BMI
Time frame: 5 minutes
Comorbidities
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Farid study director
CHU Brugmann
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Brugmann University Hospital at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery code (time frame: 5 minutes). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.