Russian Registry of Surgical OutcomeS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRussian Federation of Anesthesiologists and Reanimatologists

About this trial

Identification of risk factors that cause a high probability of an unfavorable outcome in the postoperative period is an urgent problem. The creation of national databases (registries) makes it possible to maximally cover a certain patient population by identifying its characteristic risk predictors. As literature data show, existing registries differ in the criteria for inclusion in the study, in the characteristics of the populations studied, and there is often no common view on the classification of postoperative outcomes. Goal of a study is a creation of a Russian national calculator for the risk of postoperative complications and mortality.

Two-level observational retrospective-prospective study was planned. Setting: National multicenter study of surgical inpatients. Patients: Adult patients undergoing elective and emergency surgery. Types of interventions: in obstetrics, in gynecology, on the breast, in urology and kidneys, in endocrine surgery, in maxillofacial surgery, in orthopedics and traumatology, on the lower floor of the abdominal cavity, on the liver and biliary tract, on the upper floor of the abdominal cavity cavities, in thoracic surgery, in vascular surgery, in neurosurgery, in cardiac surgery, in other areas (with mandatory specification).

The study was organized by the Federation of Anesthesiologists and Reanimatologists of Russia. Primary (30-day mortality, 30-day complications) and secondary (hospital mortality, hospital complications, length of stay in anesthesiology, resuscitation and intensive care departments, length of hospital stay, multiple organ failure (2 or more points on the SOFA scale (Sequential)) Organ Failure Assessment), 90-day mortality, 90-day complications, intensive care after-effects syndrome, readmission, 1-year mortality) outcomes were determined. The required sample size and statistical analysis methods are described. The planned duration of the study is 2024-2028.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

In obstetrics

In gynecology

Breast

In urology and kidneys

Disqualifiers

Lack of informed consent from the patient

Complications associated with the manipulations of an anesthesiologist

Interventions without the participation of an anesthesiologist-resuscitator

Incomplete checklists

Trial population

Adult patients undergoing surgery in various areas of surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

162,000 Participants
are grouped into 2 trial groups
Group A: Cohort A
Group B: Cohort B

Trial outcomes

Primary outcomes

1

Postoperative mortality

Incidence of postoperative death defined as any death occurring during and up to 30 days after surgery

Time frame
up to 30 days after surgery
2

Postoperative complications

Incidence of the following complications with severity due to Clavien-Dindo classification: Arrhythmia Cardiac arrest Cardiogenic pulmonary edema Deep vein thrombosis Myocardial infarction Myocardial damage after non-cardiac operations Pulmonary embolism Postoperative transfusion Postoperative delirium Stroke ARDS Acute respiratory failure Pneumonia Pleural effusion Atelectasis Respiratory infection Bronchospasm Pneumothorax Aspiration pneumonitis Reintubation Renal injury Infection without a specific source Laboratory confirmed bacteremia Superficial wound infection Deep wound infection Postoperative infection Urinary tract infection Sepsis Septic shock Gastrointestinal bleeding Paralytic ileus Postoperative bleeding Anastomotic leakage Dehiscence of wound Other Malignant hyperthermia Anaphylaxis Anaphylactic shock Fat embolism

Time frame
up to 30 days after surgery

Secondary outcomes

1

Length of stay in the ICU

Number of days in the ICU

Time frame
up to 30 days after surgery
2

Length of hospital stay

Number of days in the hospital

Time frame
up to 30 days after surgery
3

Multiple organ failure (2 or more points on the SOFA (Sequential Organ Failure Assessment) scale)

Incidence of MOF

Time frame
up to 30 days after surgery
4

90-days mortality

Incidence of postoperative death defined as any death occurring during and up to 90 days after anaesthesia

Time frame
up to 90 days after surgery

Other outcomes

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