Impact of the Postponement of Surgery on Postoperative Morbidity After Sars-cov-2 Infection

NCT ID: NCT05336110

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-14

Study Completion Date

2022-05-13

Brief Summary

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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

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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

Conditions

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SARS CoV 2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with a positive preoperative SARS-CoV-2 test

Patient with a positive preoperative SARS-CoV-2 test

Postponing surgery

Intervention Type OTHER

Postponing surgery for patients with Sars-cov-2 infection

Interventions

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Postponing surgery

Postponing surgery for patients with Sars-cov-2 infection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc GARNIER, MD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL TENON - PARIS

Locations

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CHU d'Amiens

Amiens, , France

Site Status

CHU d'Angers

Angers, , France

Site Status

CH Victor Dupouy

Argenteuil, , France

Site Status

Cinique Belharra

Bayonne, , France

Site Status

CH de Blois

Blois, , France

Site Status

CHU de Brest - la Cavale Blanche

Brest, , France

Site Status

HIA Clermont Tonnerre

Brest, , France

Site Status

CHU de Caen - Anesthésie Réanimation

Caen, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CH Charleville Mézière - CH Intercommunal Nord Ardennes

Charleville-Mézières, , France

Site Status

AP-HP - Hôpital Beaujon

Clamart, , France

Site Status

Hôpital Antoine Béclère, Clamart

Clamart, , France

Site Status

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

CHU Grenoble-Alpes

La Tronche, , France

Site Status

CHU de Lille - hôpital Claude Huriez

Lille, , France

Site Status

Hôpital E. Herriot - Hospices Civils de Lyon

Lyon, , France

Site Status

CHU La Timone - Marseille

Marseille, , France

Site Status

Hôpital Nord, Marseille

Marseille, , France

Site Status

Clinique du Sport de Bordeaux Mérignac

Mérignac, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

AP-H P - Hôpital Lariboisière

Paris, , France

Site Status

AP-HP - Groupe Hospitalier Pitié-Salpêtrière (bloc central)

Paris, , France

Site Status

AP-HP - Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Site Status

AP-HP - Hôpital Bichat

Paris, , France

Site Status

AP-HP - Hôpital Saint-Antoine

Paris, , France

Site Status

AP-HP - Hôpital Saint-Louis

Paris, , France

Site Status

Clinique Drouot Rémusa

Paris, , France

Site Status

Clinique Saint Jean de Dieu

Paris, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

CHU Sud Réunion (Saint-Pierre)

Saint-Pierre, , France

Site Status

CHU Strasbourg- Hautepierre

Strasbourg, , France

Site Status

CHU de Toulouse -Hôpital Purpan

Toulouse, , France

Site Status

CHU de Toulouse -Hôpital rangueil

Toulouse, , France

Site Status

Clinique Pasteur, Toulouse

Toulouse, , France

Site Status

CHRU de Tours - Hôpital Trousseau

Tours, , France

Site Status

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Centre Gustave Roussy

Villejuif, , France

Site Status

Polyclinique de Villeneuve Saint Georges

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

Other Identifiers

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2022-A00228-35

Identifier Type: OTHER

Identifier Source: secondary_id

DROMIS-22 / 2022-01

Identifier Type: -

Identifier Source: org_study_id

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