Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000498998
Ethics application status
Approved
Date submitted
15/04/2020
Date registered
20/04/2020
Date last updated
20/04/2020
Date data sharing statement initially provided
20/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Retrospective Study on surgical outcomes among surgical patients during the COVID-19 (SARS-CoV-2) Pandemic
Scientific title
Retrospective cohort study of COVID-19 infection among surgical patients after surgery
Secondary ID [1] 301017 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Positive 317057 0
Scheduled surgery 317058 0
Emergency surgery 317059 0
Condition category
Condition code
Respiratory 315222 315222 0 0
Other respiratory disorders / diseases
Infection 315223 315223 0 0
Other infectious diseases
Surgery 315224 315224 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
incidence of Sars-COV-2 infection in patients undergoing surgery from Feburary 2020 to April 2020
No involvment for the patients, and the medical charts will be review to gather informations needed.
For each participant medical chart will be check 2 weeks after surgery or at the date of hospital discharge if their hospital stay is longer than two weeks
Intervention code [1] 317332 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323479 0
Incidence of Sars-COV-2 infection during hospital stay :
- positive rt-PCR or high clinical suspicion with typical parenchymal lesion
Timepoint [1] 323479 0
From day of surgery until 2 weeks post operative. If hospital stay exceeds 2 weeks, it'll be assess at hospital discharge
Secondary outcome [1] 382024 0
Death of surgical patients with Sars-COV-2 infection
SARS-COV-2 assessment ::
- positive rt-PCR or high clinical suspicion with typical parenchymal lesion
Timepoint [1] 382024 0
from day of surgery until discharge or death (information will be gathered from medical chart)

Eligibility
Key inclusion criteria
Adult (18+ years old) patients undergoing surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre operative confirmed Sars-COV-2 infection

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment outside Australia
Country [1] 22493 0
France
State/province [1] 22493 0

Funding & Sponsors
Funding source category [1] 305461 0
Hospital
Name [1] 305461 0
Anesthesiology Intensive Care and peri operative medicine department, Tenon hospital
Country [1] 305461 0
France
Primary sponsor type
Hospital
Name
Anesthesiology Intensive Care and peri operative medicine department, Tenon hospital
Address
4 rue de la Chine
75020 Paris
France
Country
France
Secondary sponsor category [1] 305858 0
None
Name [1] 305858 0
Address [1] 305858 0
Country [1] 305858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305776 0
Comité d’éthique pour la recherche en Anesthésie­-Réanimation (French IRB)
Ethics committee address [1] 305776 0
74 rue Raynouard
75016 Paris
FRANCE
Ethics committee country [1] 305776 0
France
Date submitted for ethics approval [1] 305776 0
03/04/2020
Approval date [1] 305776 0
06/04/2020
Ethics approval number [1] 305776 0
IRB 00010254 -­- 2020 -­- 054

Summary
Brief summary
On March 11, 2020, WHO declared that the COVID-19 epidemic had become a pandemic.

Health authorities around the word are taking measures to increase conventional hospitalization and intensive care capacity. So, the way surgery is performed have changed. Emergency surgery remains a priority, and functional surgery has to be postponed. The main question concerns oncological surgery, operate or postpone? There is probably a risk induced by the pandemic COVID 19 which must be balanced against the oncological risk linked to delay in surgery.
A Chinese report described that cancer patients are more likely to develop infection by the virus due to their immunosuppression secondary to cancer, chemotherapy and surgery. This article also highlights that these patients are at higher risk of developing severe episodes (39% vs 8%). Patients who underwent surgery or received chemotherapy in the month before the virus appeared had a greater risk (75%) of developing a severe episode than those who did not undergo surgery or did not receive chemotherapy (43%).

The objective of our report is to share our experience of performing scheduled and urgent surgery in COVID-19 pandemic. We report the perioperative characteristics and outcome of patients in whom surgery was undertaken.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101558 0
Dr Julien BUREY
Address 101558 0
Département d'anesthésie, réanimation et médecine péri opératoire
4 rue de la chine
75020 Paris
France
Country 101558 0
France
Phone 101558 0
+33156017898
Fax 101558 0
Email 101558 0
[email protected]
Contact person for public queries
Name 101559 0
Dr Julien BUREY
Address 101559 0
Département d'anesthésie, réanimation et médecine péri opératoire
4 rue de la chine
75020 Paris
France
Country 101559 0
France
Phone 101559 0
+33156017898
Fax 101559 0
Email 101559 0
[email protected]
Contact person for scientific queries
Name 101560 0
Prof Christophe QUESNEL
Address 101560 0
Département d'anesthésie, réanimation et médecine péri opératoire
4 rue de la chine
75020 Paris
France
Country 101560 0
France
Phone 101560 0
+33156017898
Fax 101560 0
Email 101560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Extracted data detailing sex, age, operation type, clinical characteristics (including symptoms/signs, blood test results, and throat swab nucleic acid), and type of surgery from electronic medical records.
Lymphocytes, Platets and haemoglobin counts after surgery were also recorded.

All the data will be shared.
When will data be available (start and end dates)?
From 1st of June 2020 to 1st of June 2021
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
On demand by emailing the Primary Sponsor
Enquiries should be directed to [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.