Impact of the Postponement of Surgery on Postoperative Morbidity After Sars-cov-2 Infection (DROMIS-22)

Assessment of the Impact of the Postponement of Surgery on the Postoperative Morbidity After Sars-cov-2 Infection in 2022

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

Study Overview

• Status: Completed
• Conditions: SARS CoV 2 Infection
• Intervention / Treatment: Other: Postponing surgery

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 Type: Observational
• Enrollment (Actual): 5189

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU d'Amiens
  • Angers, France
    • CHU d'Angers
  • Argenteuil, France
    • CH Victor Dupouy
  • Bayonne, France
    • Cinique Belharra
  • Blois, France
    • CH de Blois
  • Brest, France
    • HIA Clermont Tonnerre
  • Brest, France
    • CHU de Brest - la Cavale Blanche
  • Caen, France
    • CHU de Caen
  • Caen, France
    • CHU de Caen - Anesthésie Réanimation
  • Charleville-Mézières, France
    • CH Charleville Mézière - CH Intercommunal Nord Ardennes
  • Clamart, France
    • AP-HP - Hôpital Beaujon
  • Clamart, France
    • Hopital Antoine Béclère, CLAMART
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand
  • Corbeil-Essonnes, France
    • Centre Hospitalier Sud Francilien
  • La Tronche, France
    • CHU Grenoble-Alpes
  • Lille, France
    • CHU de Lille - Hopital Claude Huriez
  • Lyon, France
    • Hôpital E. Herriot - Hospices Civils de Lyon
  • Marseille, France
    • CHU la Timone - Marseille
  • Marseille, France
    • Hôpital Nord, Marseille
  • Mérignac, France
    • Clinique du Sport de Bordeaux Mérignac
  • Nantes, France
    • CHU de Nantes
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France
    • AP-HP - Hôpital Bichat
  • Paris, France
    • AP-HP - Groupe Hospitalier Pitié-Salpêtrière
  • Paris, France
    • AP-HP - Hôpital Saint-Louis
  • Paris, France
    • AP-H P - Hôpital Lariboisière
  • Paris, France
    • AP-HP - Groupe Hospitalier Pitié-Salpêtrière (bloc central)
  • Paris, France
    • Ap-Hp - Hopital Saint-Antoine
  • Paris, France
    • Clinique Drouot Rémusa
  • Paris, France
    • Clinique Saint Jean de Dieu
  • Rouen, France
    • Centre Henri Becquerel
  • Saint-Pierre, France
    • CHU Sud Réunion (Saint-Pierre)
  • Strasbourg, France
    • CHU Strasbourg- Hautepierre
  • Toulouse, France
    • CHU de Toulouse -Hôpital Purpan
  • Toulouse, France
    • CHU de Toulouse -Hôpital rangueil
  • Toulouse, France
    • Clinique Pasteur, Toulouse
  • Tours, France
    • CHRU de Tours - Hôpital Trousseau
  • Vandœuvre-lès-Nancy, France
    • Institut de Cancérologie de Lorraine
  • Villejuif, France
    • Centre Gustave Roussy
  • Villeneuve-Saint-Georges, France
    • Polyclinique de Villeneuve Saint Georges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient going to have surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with a positive preoperative SARS-CoV-2 test	Other: Postponing surgery; Postponing surgery for patients with Sars-cov-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint, that consist of respiratory morbidity associated with occurrence of respiratory events and use or prolongation of mechanical ventilation.	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.	up to 30 postoperative days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measures include hospital mortality,	The secondary endpoints will be the hospital mortality (number of death during hospitalization)	up to 30 postoperative days.
Secondary Outcome Measures include mortality at D30,	The secondary endpoints will be the mortality at D30 (number of death since surgery until Day 30);	up to 30 postoperative days.
Secondary Outcome Measures include the occurrence of a deep vein thrombosis,	The secondary endpoints will be the number of occurrence of a deep vein thrombosis (excluding pulmonary embolism),	up to 30 postoperative days.
Secondary Outcome Measures include non-respiratory infection and septic shock,	The secondary endpoints will be the numberof non-respiratory infection or septic shock during the post-operative hospital stay and within the limit of postoperative 30 days.	up to 30 postoperative days.
Secondary Outcome Measures include non-respiratory infection or septic shock,	The secondary endpoints will be the number of non-respiratory infection or septic shock during the post-operative hospital stay and within the limit of postoperative 30 days.	up to 30 postoperative days.
Secondary Outcome Measures include length of hospital stay and length of critical care stay.	The secondary endpoints will be the length of hospital stay, length of critical care stay (if hospitalization in critical care).	up to 30 postoperative days.
Secondary Outcome Measures include the need for re-hospitalization during the first 30 days after surgery	The secondary endpoints will be the need for re-hospitalization during the first 30 days after surgery (number of patients with re-hospitalization)	up to 30 postoperative days.

Collaborators and Investigators

• Sponsor: Société Française d'Anesthésie et de Réanimation
• Investigators: Principal Investigator: Marc GARNIER, MD, HOPITAL TENON - PARIS

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: DROMIS-22 / 2022-01; 2022-A00228-35 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No