Clinical trial NCT05336110: Impact of the Postponement of Surgery on Postoperative Morbidity After Sars-cov-2 Infection
Official title: Assessment of the Impact of the Postponement of Surgery on the Postoperative Morbidity After Sars-cov-2 Infection in 2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 5189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient going to have surgery

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

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint, that consist of respiratory morbidity associated with occurrence of respiratory events and use or prolongation of mechanical ventilation.
timeFrame: up to 30 postoperative days.
Secondary outcomes:
measure: Secondary Outcome Measures include hospital mortality,
timeFrame: up to 30 postoperative days.
measure: Secondary Outcome Measures include mortality at D30,
timeFrame: up to 30 postoperative days.
measure: Secondary Outcome Measures include the occurrence of a deep vein thrombosis,
timeFrame: up to 30 postoperative days.
measure: Secondary Outcome Measures include non-respiratory infection and septic shock,
timeFrame: up to 30 postoperative days.
measure: Secondary Outcome Measures include non-respiratory infection or septic shock,
timeFrame: up to 30 postoperative days.
measure: Secondary Outcome Measures include length of hospital stay and length of critical care stay.
timeFrame: up to 30 postoperative days.
measure: Secondary Outcome Measures include the need for re-hospitalization during the first 30 days after surgery
timeFrame: up to 30 postoperative days.
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Bayonne
country: France
facility: Cinique Belharra
city: Blois
country: France
facility: CH de Blois
city: Brest
country: France
facility: CHU de Brest - la Cavale Blanche
city: Brest
country: France
facility: HIA Clermont Tonnerre
city: Caen
country: France
facility: CHU de Caen - Anesthésie Réanimation
city: Caen
country: France
facility: CHU de Caen
city: Charleville-Mézières
country: France
facility: CH Charleville Mézière - CH Intercommunal Nord Ardennes
city: Clamart
country: France
facility: AP-HP - Hôpital Beaujon
city: Clamart
country: France
facility: Hôpital Antoine Béclère, Clamart
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: La Tronche
country: France
facility: CHU Grenoble-Alpes
city: Lille
country: France
facility: CHU de Lille - hôpital Claude Huriez
city: Lyon
country: France
facility: Hôpital E. Herriot - Hospices Civils de Lyon
city: Marseille
country: France
facility: CHU La Timone - Marseille
city: Marseille
country: France
facility: Hôpital Nord, Marseille
city: Mérignac
country: France
facility: Clinique du Sport de Bordeaux Mérignac
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: AP-H P - Hôpital Lariboisière
city: Paris
country: France
facility: AP-HP - Groupe Hospitalier Pitié-Salpêtrière (bloc central)
city: Paris
country: France
facility: AP-HP - Groupe Hospitalier Pitié-Salpêtrière
city: Paris
country: France
facility: AP-HP - Hôpital Bichat
city: Paris
country: France
facility: AP-HP - Hôpital Saint-Antoine
city: Paris
country: France
facility: AP-HP - Hôpital Saint-Louis
city: Paris
country: France
facility: Clinique Drouot Rémusa
city: Paris
country: France
facility: Clinique Saint Jean de Dieu
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Pierre
country: France
facility: CHU Sud Réunion (Saint-Pierre)
city: Strasbourg
country: France
facility: CHU Strasbourg- Hautepierre
city: Toulouse
country: France
facility: CHU de Toulouse -Hôpital Purpan
city: Toulouse
country: France
facility: CHU de Toulouse -Hôpital rangueil
city: Toulouse
country: France
facility: Clinique Pasteur, Toulouse
city: Tours
country: France
facility: CHRU de Tours - Hôpital Trousseau
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Villejuif
country: France
facility: Centre Gustave Roussy
city: Villeneuve-Saint-Georges
country: France
facility: Polyclinique de Villeneuve Saint Georges
Study officials:
affiliation: HOPITAL TENON - PARIS
name: Marc GARNIER, MD
role: PRINCIPAL_INVESTIGATOR
References: