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NCT Number: NCT05336110

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens, Amiens, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postponing surgery

Other

Postponing surgery for patients with Sars-cov-2 infection

Primary outcomes

  1. 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.

Secondary outcomes

  1. Secondary Outcome Measures include hospital mortality,

    Time frame: up to 30 postoperative days.

    The secondary endpoints will be the hospital mortality (number of death during hospitalization)

  2. Secondary Outcome Measures include mortality at D30,

    Time frame: up to 30 postoperative days.

    The secondary endpoints will be the mortality at D30 (number of death since surgery until Day 30);

  3. Secondary Outcome Measures include the occurrence of a deep vein thrombosis,

    Time frame: up to 30 postoperative days.

    The secondary endpoints will be the number of occurrence of a deep vein thrombosis (excluding pulmonary embolism),

  4. Secondary Outcome Measures include non-respiratory infection and septic shock,

    Time frame: up to 30 postoperative days.

    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.

  5. Secondary Outcome Measures include non-respiratory infection or septic shock,

    Time frame: up to 30 postoperative days.

    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.

  6. Secondary Outcome Measures include length of hospital stay and length of critical care stay.

    Time frame: up to 30 postoperative days.

    The secondary endpoints will be the length of hospital stay, length of critical care stay (if hospitalization in critical care).

  7. Secondary Outcome Measures include the need for re-hospitalization during the first 30 days after surgery

    Time frame: up to 30 postoperative days.

    The secondary endpoints will be the need for re-hospitalization during the first 30 days after surgery (number of patients with re-hospitalization)

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Official study title

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

Acronym: DROMIS-22

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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