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

S

Société Française d'Anesthésie et de Réanimation

Status

Completed

Conditions

SARS CoV 2 Infection

Treatments

Other: Postponing surgery

Study type

Observational

Funder types

Other

Identifiers

NCT05336110
2022-A00228-35 (Other Identifier)
DROMIS-22 / 2022-01

Details and patient eligibility

About

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

Full 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

Enrollment

5,189 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

5,189 participants in 1 patient group

Patient with a positive preoperative SARS-CoV-2 test
Description:
Patient with a positive preoperative SARS-CoV-2 test
Treatment:
Other: Postponing surgery

Trial contacts and locations

40

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Data sourced from clinicaltrials.gov

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