RecruitingNCT06146270

Russian Registry of Surgical OutcomeS

National Register of Postoperative Outcomes in the Russian Federation: a Multicenter Observational Study


Sponsor

Russian Federation of Anesthesiologists and Reanimatologists

Enrollment

162,000 participants

Start Date

Jan 9, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria17

  • Adult patients (age 18 years and older) undergoing elective surgery:
  • In obstetrics
  • In gynecology
  • Breast
  • In urology and kidneys
  • In endocrine surgery
  • In maxillofacial surgery
  • In orthopedics and traumatology
  • On the lower abdominal cavity
  • On the liver and biliary tract
  • On the upper abdominal cavity
  • In thoracic surgery
  • In vascular surgery
  • In neurosurgery
  • In cardiac surgery
  • In other areas (with mandatory specification)
  • Adult patients (age 18 years and older) undergoing emergency surgery in the listed and other areas of surgery (for example, in purulent surgery).

Exclusion Criteria6

  • 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
  • Errors when filling checklists
  • Deviations from the Register protocol

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Locations(16)

The First City Clinical Hospital. n.a. E. E. Volosevich

Arkhangelsk, Russia

Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky

Kemerovo, Russia

Regional clinical hospital №2

Krasnodar, Russia

Kuban State Medical University

Krasnodar, Russia

Krasnodar regional hospital №2 (Kuban State Medical University)

Krasnodar, Russia

Regional clinical hospital

Krasnoyarsk, Russia

Federal research and clinical center of intensive care medicine and rehabilitology

Moscow, Russia

Loginov Moscow Clinical Scientific Center

Moscow, Russia

Military Medical Academy

Moscow, Russia

Moscow cancer research Institute named after P. A. Herzen

Moscow, Russia

Moscow Regional Research and Clinical Institute, Moscow, Russia

Moscow, Russia

Moscow regional research clinical Institute named after M. F. Vladimirsky

Moscow, Russia

Orenburg City N.I. Pirogov Clinical Hospital

Orenburg, Russia

North-Western State Medical University named after Ilya I. Mechnikov,

Saint Petersburg, Russia

Regional clinical hospital №2

Vladivostok, Russia

Clinical city hospital № 40

Yekaterinburg, Russia

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NCT06146270


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