Assessment of the Impact of the Postponement of Surgery on the Postoperative Morbidity After Sars-cov-2 Infection in 2022
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5,189
- Locations
- 40
- Primary Endpoint
- Composite endpoint, that consist of respiratory morbidity associated with occurrence of respiratory events and use or prolongation of mechanical ventilation.
Study Overview
Brief Summary
The deployment of vaccination against SARS-CoV-2 from 2021 led to a modification in June 2021of previous recommendations concerning the postponing scheduled surgery suggesting local adaptations of this delay if epidemic developments appear. Today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. Among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand
Detailed Description
Previous studies performed during the first COVID-19 epidemic wave in the first half of 2020 led to the recommendation, after taking into account the individual risk-benefit balance, of postponing scheduled surgery for ideally at least 6 completed weeks in a patient with a positive preoperative SARS-CoV-2 PCR.
The deployment of vaccination against SARS-CoV-2 from 2021 led to a modification of these recommendations in June 2021 suggesting local adaptations of this delay if epidemic developments appear. Today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. Among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients,
- •Surgery performed in the operating room under general or locoregional anesthesia.
- •Result of the preoperative SARS-COV-2 diagnostic test available on the day of the procedure or within 48 hours of the surgery.
- •Emergency or scheduled surgery
- •All surgical indications will be eligible with the exception of certain surgeries
Exclusion Criteria
- •Minor patient
- •Pregnant patient
- •Surgery or an intervention performed outside the operating room
- •Patient operated under sedation alone,
- •Patient under guardianship or curatorship
- •Patient without social protection
- •Patient previously included in this study
- •Patient without preoperative COVID-19 status on day of surgery and not diagnosable within 48 postoperative hours
- •Patient whose immediate postoperative follow-up is planned in a structure other than those where the inclusion was made
Outcomes
Primary Outcomes
Composite endpoint, that consist of respiratory morbidity associated with occurrence of respiratory events and use or prolongation of mechanical ventilation.
Time Frame: up to 30 postoperative days.
The primary endpoint will be a composite endpoint, that consist of respiratory morbidity associated with occurrence of pneumonia (bacterial or viral), acute respiratory distress, symptomatic pulmonary embolism (i.e. having led to a diagnostic procedure and a treatment), and postoperative prolongation of mechanical ventilation or the use of unscheduled, during the postoperative hospital stay and within the limit of 30 postoperative days.
Secondary Outcomes
- Secondary Outcome Measures include hospital mortality,(up to 30 postoperative days.)
- Secondary Outcome Measures include non-respiratory infection or septic shock,(up to 30 postoperative days.)
- Secondary Outcome Measures include length of hospital stay and length of critical care stay.(up to 30 postoperative days.)
- Secondary Outcome Measures include the need for re-hospitalization during the first 30 days after surgery(up to 30 postoperative days.)
- Secondary Outcome Measures include mortality at D30,(up to 30 postoperative days.)
- Secondary Outcome Measures include the occurrence of a deep vein thrombosis,(up to 30 postoperative days.)
- Secondary Outcome Measures include non-respiratory infection and septic shock,(up to 30 postoperative days.)