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
2 other identifiers
observational
5,189
1 country
40
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Shorter than P25 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2022
CompletedFirst Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2022
CompletedJuly 18, 2022
July 1, 2022
2 months
March 21, 2022
July 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Secondary Outcome Measures include hospital mortality,
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.
Secondary Outcome Measures include non-respiratory infection or septic shock,
up to 30 postoperative days.
- +2 more secondary outcomes
Study Arms (1)
Patient with a positive preoperative SARS-CoV-2 test
Patient with a positive preoperative SARS-CoV-2 test
Interventions
Postponing surgery for patients with Sars-cov-2 infection
Eligibility Criteria
Patient going to have surgery
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
CH Victor Dupouy
Argenteuil, France
Cinique Belharra
Bayonne, France
CH de Blois
Blois, France
CHU de Brest - la Cavale Blanche
Brest, France
HIA Clermont Tonnerre
Brest, France
CHU de Caen - Anesthésie Réanimation
Caen, France
CHU de Caen
Caen, France
CH Charleville Mézière - CH Intercommunal Nord Ardennes
Charleville-Mézières, France
AP-HP - Hôpital Beaujon
Clamart, France
Hôpital Antoine Béclère, Clamart
Clamart, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
CHU Grenoble-Alpes
La Tronche, France
CHU de Lille - hôpital Claude Huriez
Lille, France
Hôpital E. Herriot - Hospices Civils de Lyon
Lyon, France
CHU La Timone - Marseille
Marseille, France
Hôpital Nord, Marseille
Marseille, France
Clinique du Sport de Bordeaux Mérignac
Mérignac, France
CHU de Nantes
Nantes, France
Hopital Tenon
Paris, 75020, France
AP-H P - Hôpital Lariboisière
Paris, France
AP-HP - Groupe Hospitalier Pitié-Salpêtrière (bloc central)
Paris, France
AP-HP - Groupe Hospitalier Pitié-Salpêtrière
Paris, France
AP-HP - Hôpital Bichat
Paris, France
AP-HP - Hôpital Saint-Antoine
Paris, France
AP-HP - Hôpital Saint-Louis
Paris, France
Clinique Drouot Rémusa
Paris, France
Clinique Saint Jean de Dieu
Paris, France
Centre Henri Becquerel
Rouen, France
CHU Sud Réunion (Saint-Pierre)
Saint-Pierre, France
CHU Strasbourg- Hautepierre
Strasbourg, France
CHU de Toulouse -Hôpital Purpan
Toulouse, France
CHU de Toulouse -Hôpital rangueil
Toulouse, France
Clinique Pasteur, Toulouse
Toulouse, France
CHRU de Tours - Hôpital Trousseau
Tours, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Centre Gustave Roussy
Villejuif, France
Polyclinique de Villeneuve Saint Georges
Villeneuve-Saint-Georges, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc GARNIER, MD
HOPITAL TENON - PARIS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
April 20, 2022
Study Start
March 14, 2022
Primary Completion
May 13, 2022
Study Completion
May 13, 2022
Last Updated
July 18, 2022
Record last verified: 2022-07