Russian Registry of Surgical OutcomeS

NCT06146270 | Recruiting

• 1 other identifier: FARCT0005
• Study Type: observational
• Target: 162,000
• Locations: 1 country
• Sites: 16

Brief 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

Outcome Measures

Primary Outcomes (2)

• Postoperative mortality

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

  up to 30 days after surgery

• 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

  up to 30 days after surgery

Secondary Outcomes (8)

• Length of stay in the ICU

  up to 30 days after surgery

• Length of hospital stay

  up to 30 days after surgery

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

  up to 30 days after surgery

• 90-days mortality

  up to 90 days after surgery

• 90-days postoperative complications

  up to 90 days after surgery

Study Arms (2)

Cohort A

A cohort in which the incidence of the primary outcomes in the study population will be assessed.

Cohort B

A cohort in which risk factors for primary outcomes will be identified, and a risk calculator for their development will be developed and validated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing surgery in various areas of surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Russian Federation of Anesthesiologists and Reanimatologists: lead
• Kuban State Medical University: collaborator

Study Sites (16)

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

Arkhangelsk, Russia

RECRUITING

Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky

Kemerovo, Russia

RECRUITING

Regional clinical hospital №2

Krasnodar, 350012, Russia

RECRUITING

Kuban State Medical University

Krasnodar, 350063, Russia

RECRUITING

Krasnodar regional hospital №2 (Kuban State Medical University)

Krasnodar, Russia

NOT YET RECRUITING

Regional clinical hospital

Krasnoyarsk, Russia

RECRUITING

Federal research and clinical center of intensive care medicine and rehabilitology

Moscow, Russia

RECRUITING

Loginov Moscow Clinical Scientific Center

Moscow, Russia

NOT YET RECRUITING

Military Medical Academy

Moscow, Russia

NOT YET RECRUITING

Moscow cancer research Institute named after P. A. Herzen

Moscow, Russia

RECRUITING

Moscow Regional Research and Clinical Institute, Moscow, Russia

Moscow, Russia

NOT YET RECRUITING

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

Moscow, Russia

RECRUITING

Orenburg City N.I. Pirogov Clinical Hospital

Orenburg, Russia

RECRUITING

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

Saint Petersburg, Russia

NOT YET RECRUITING

Regional clinical hospital №2

Vladivostok, Russia

RECRUITING

Clinical city hospital № 40

Yekaterinburg, Russia

RECRUITING

Study Officials

• Igor Zabolotskikh, MD

  Kuban State Medical University

  STUDY CHAIR

• Nikita Trembach, MD

  Kuban State Medical University

  STUDY DIRECTOR

• Andrey Belkin, MD

  Clinical Institute of Brain

  STUDY DIRECTOR

• Evgeniy Grigiriev, MD

  Research Institute for Complex Issues of Cardiovascular Diseases

  STUDY DIRECTOR

• Alexei Gritsan, MD

  Voino-Yasenetsky Krasnoyarsk State Medical University

  STUDY DIRECTOR

• Pavel Dunts, PhD

  Pacific State Medical University

  STUDY DIRECTOR

• Vadim Ershov, MD

  Orenburg State Medical University

  STUDY DIRECTOR

• Mikhail Kirov, MD

  Northern State Medical University

  STUDY DIRECTOR

• Artem Kuzovlev, MD

  Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

  STUDY DIRECTOR

• Alexandr Kulikov, MD

  Ural State Medical University

  STUDY DIRECTOR

• Alexey Ovezov, MD

  Moscow Regional Research and Clinical Institute

  STUDY DIRECTOR

• Denis Protsenko, MD

  Pirogov Russian National Research Medical University

  STUDY DIRECTOR

• Valeriy Subbotin, MD

  Loginov Moscow Clinical Scientific Center

  STUDY DIRECTOR

• Victoria Khoronenko, MD

  P. A. Hertsen Moscow Oncology Research Center

  STUDY DIRECTOR

• Efim Shifman, MD

  Moscow Regional Research and Clinical Institute, Moscow, Russia

  STUDY DIRECTOR

• Alexey Shchegolev, MD

  Military Medical Academy, Bulgaria

  STUDY DIRECTOR

• Konstantin Lebedinskii, MD

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

  STUDY DIRECTOR

Central Study Contacts

Igor Zabolotskikh, MD

CONTACT

+79183883499; pobeda_zib@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 24, 2023
• Study Start: January 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

RU (16)