- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brussel, Belgium, 1090
- UZ Brussel
-
Brussels, Belgium, 1020
- CHU Brugmann
-
Brussels, Belgium, 1070
- Erasme
-
Brussels, Belgium, 1000
- St Pierre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Director: Yasser Farid, CHU Brugmann
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-Farid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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