SARS CoV 2 InfectionDROMIS-22NCT05336110
Impact of the Postponement of Surgery on Postoperative Morbidity After Sars-cov-2 Infection
An observational study of SARS CoV 2 Infection, run by Société Française d'Anesthésie et de Réanimation at 40 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- Postponing surgery
- How many people
- 5,189 participants
- Where
- 40 sitesFrance
- Study dates
- 14 Mar 2022to 13 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient going to have surgery
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
CHU d'Amiens
Amiens
CHU d'Angers
Angers
CH Victor Dupouy
Argenteuil
Cinique Belharra
Bayonne
CH de Blois
Blois
CHU de Brest - la Cavale Blanche
Brest
HIA Clermont Tonnerre
Brest
CHU de Caen - Anesthésie Réanimation
Caen
CHU de Caen
Caen
CH Charleville Mézière - CH Intercommunal Nord Ardennes
Charleville-Mézières
AP-HP - Hôpital Beaujon
Clamart
Hôpital Antoine Béclère, Clamart
Clamart
CHU Clermont-Ferrand
Clermont-Ferrand
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
CHU Grenoble-Alpes
La Tronche
CHU de Lille - hôpital Claude Huriez
Lille
Hôpital E. Herriot - Hospices Civils de Lyon
Lyon
CHU La Timone - Marseille
Marseille
Hôpital Nord, Marseille
Marseille
Clinique du Sport de Bordeaux Mérignac
Mérignac
CHU de Nantes
Nantes
Hopital Tenon
Paris, 75020
AP-H P - Hôpital Lariboisière
Paris
AP-HP - Groupe Hospitalier Pitié-Salpêtrière (bloc central)
Paris
AP-HP - Groupe Hospitalier Pitié-Salpêtrière
Paris
AP-HP - Hôpital Bichat
Paris
AP-HP - Hôpital Saint-Antoine
Paris
AP-HP - Hôpital Saint-Louis
Paris
Clinique Drouot Rémusa
Paris
Clinique Saint Jean de Dieu
Paris
Centre Henri Becquerel
Rouen
CHU Sud Réunion (Saint-Pierre)
Saint-Pierre
CHU Strasbourg- Hautepierre
Strasbourg
CHU de Toulouse -Hôpital Purpan
Toulouse
CHU de Toulouse -Hôpital rangueil
Toulouse
Clinique Pasteur, Toulouse
Toulouse
CHRU de Tours - Hôpital Trousseau
Tours
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Centre Gustave Roussy
Villejuif
Polyclinique de Villeneuve Saint Georges
Villeneuve-Saint-Georges
About this study
Official title: 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
Read the 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
- Conditions
- SARS CoV 2 Infection
- Being tested
- Postponing surgery
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postponing surgeryOther
Postponing surgery for patients with Sars-cov-2 infection
| Study group | Role | What they receive |
|---|---|---|
| Patient with a positive preoperative SARS-CoV-2 test | Patient with a positive preoperative SARS-CoV-2 test Receives: Other: Postponing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 postoperative days.
Secondary outcomes (7)
Secondary Outcome Measures include hospital mortality,
The secondary endpoints will be the hospital mortality (number of death during hospitalization)
Measured: 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);
Measured: 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),
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: up to 30 postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start14 Mar 2022
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc GARNIER, MD, Principal investigator, HOPITAL TENON - PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336110
- Sponsor's protocol ID
- DROMIS-22 / 2022-01
- Other IDs
- 2022-A00228-35
- Acronym
- DROMIS-22
- Status last verified
- Jul 2022
- First submitted
- 21 Mar 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of the Postponement of Surgery on the Postoperative Morbidity After Sars-cov-2 Infection in 2022
- ClinicalTrials.gov ID
- NCT05336110
- Acronym / sponsor ID
- DROMIS-22 / DROMIS-22 / 2022-01
- Conditions
- SARS CoV 2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,189 participants (actual)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with a positive preoperative SARS-CoV-2 test | – | Other: Postponing surgeryPatient with a positive preoperative SARS-CoV-2 test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient going to have surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Minor patient
- Pregnant patient
- Surgery or an intervention performed outside the operating room
- Patient operated under sedation alone,
- Patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postponing surgeryPostponing surgery for patients with Sars-cov-2 infection | Other | Patient with a positive preoperative SARS-CoV-2 test |
Primary outcome
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.
7 secondary outcomes
Secondary Outcome Measures include hospital mortality,
Time frame: up to 30 postoperative days.
Secondary Outcome Measures include mortality at D30,
Time frame: up to 30 postoperative days.
Secondary Outcome Measures include the occurrence of a deep vein thrombosis,
Time frame: up to 30 postoperative days.
Secondary Outcome Measures include non-respiratory infection and septic shock,
Time frame: up to 30 postoperative days.
Secondary Outcome Measures include non-respiratory infection or septic shock,
Time frame: up to 30 postoperative days.
Secondary Outcome Measures include length of hospital stay and length of critical care stay.
Time frame: up to 30 postoperative days.
Secondary Outcome Measures include the need for re-hospitalization during the first 30 days after surgery
Time frame: up to 30 postoperative days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc GARNIER, MD principal investigator
HOPITAL TENON - PARIS
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection, run by Société Française d'Anesthésie et de Réanimation at 40 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.