Russian Registry of Surgical OutcomeS

NCT06146270 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 162000

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Surgery
  • Anesthesia
  • Outcome, Fatal
  • Complication

Sponsors & Collaborators

  • Kuban State Medical University

    collaborator OTHER
  • Russian Federation of Anesthesiologists and Reanimatologists

    lead OTHER

Principal Investigators

  • Igor Zabolotskikh, MD · Kuban State Medical University

  • Nikita Trembach, MD · Kuban State Medical University

  • Andrey Belkin, MD · Clinical Institute of Brain

  • Evgeniy Grigiriev, MD · Research Institute for Complex Issues of Cardiovascular Diseases

  • Alexei Gritsan, MD · Voino-Yasenetsky Krasnoyarsk State Medical University

  • Pavel Dunts, PhD · Pacific State Medical University

  • Vadim Ershov, MD · Orenburg State Medical University

  • Mikhail Kirov, MD · Northern State Medical University

  • Artem Kuzovlev, MD · Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

  • Alexandr Kulikov, MD · Ural State Medical University

  • Alexey Ovezov, MD · Moscow Regional Research and Clinical Institute

  • Denis Protsenko, MD · Pirogov Russian National Research Medical University

  • Valeriy Subbotin, MD · Loginov Moscow Clinical Scientific Center

  • Victoria Khoronenko, MD · P. A. Hertsen Moscow Oncology Research Center

  • Efim Shifman, MD · Moscow Regional Research and Clinical Institute, Moscow, Russia

  • Alexey Shchegolev, MD · Military Medical Academy, Bulgaria

  • Konstantin Lebedinskii, MD · North-Western State Medical University named after Ilya I. Mechnikov

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06146270 on ClinicalTrials.gov