Surgery in the Time of COVID-19 Pandemic

Covid19 Clinical Trial

Official title:

Surgery in the Time of COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684433
• Other study ID #: CHUB-Farid
• Status: Completed
• Start date: April 14, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2021
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Data extraction from medical files
Data extraction from medical files

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
Belgium	CHU Brugmann	Brussels
Belgium	Erasme	Brussels
Belgium	St Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery code	Type of surgery as defined by the surgery code	5 minutes
Primary	Urgency	Degree of urgency of the surgery	5 minutes
Primary	Type of anesthesia	Type of anesthesia	5 minutes
Primary	Delay between surgery and first symptoms	Delay between surgery and first symptoms	5 minutes
Primary	Surgery duration	Surgery duration (anesthesia included)	5 minutes
Primary	Hospital stay (in days)	Hospital stay (in days)	5 minutes
Primary	Intensive care unit stay (in days)	Intensive care unit stay (in days)	5 minutes
Primary	Post-op complications	Post-op complications	5 minutes
Primary	Covid status before surgery	Covid status before surgery (positive=1, negative=0 )	5 minutes
Primary	Covid status post-surgery	Covid status post-op (positive=1, negative=0 )	5 minutes
Primary	COVID19 Diagnosis by CT scan	COVID19 Diagnosis confirmed by CT scan of the thorax (Yes=1, No=0)	5 minutes
Primary	COVID19 Diagnosis by swab test	COVID19 Diagnosis by swab test (Yes=1, No=0)	5 minutes
Primary	COVID 19 Diagnosis by antibody test	COVID 19 Diagnosis by antibody test (Yes=1, No=0)	5 minutes
Primary	COVID19 symptoms - dry cough	dry cough (Yes=1, No=0)	5 minutes
Primary	COVID19 symptoms - fever	fever (Yes=1, No=0)	5 minutes
Primary	COVID19 symptoms - myalgia	myalgia (Yes=1, No=0)	5 minutes
Primary	COVID19 symptoms - anosmia	anosmia (Yes=1, No=0)	5 minutes
Primary	COVID19 symptoms -respiratory distress	respiratory distress (Yes=1, No=0)	5 minutes
Primary	Treatment for COVID19 - Plaquenil	Plaquenil (Yes=1, No=0)	5 minutes
Primary	Treatment for COVID19 - Antivirals	Antivirals (Yes=1, No=0)	5 minutes
Primary	Need for intubation	Need for intubation (Yes=1, No=0)	5 minutes
Primary	Death	Mortality (Yes=1, No=0)	5 minutes
Secondary	Age	Patient age	5 minutes
Secondary	Gender	Patient gender	5 minutes
Secondary	Ethnicity	Patient ethnicity	5 minutes
Secondary	BMI	Patient Body Mass Index	5 minutes
Secondary	Comorbidities	Patient comorbidities	5 minutes