SurgeryRuSOSNCT06146270
Russian Registry of Surgical OutcomeS
An observational study of Surgery and Anesthesia, run by Russian Federation of Anesthesiologists and Reanimatologists at 16 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Anesthesia, Outcome, Fatal
- How many people
- 162,000 participants
- Where
- 16 sitesRussia
- Study dates
- 9 Jan 2025to 31 Jan 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing surgery in various areas of surgery
Who may be able to join
- Adult patients (age 18 years and older) undergoing elective surgery:
- In obstetrics
- In gynecology
- Breast
- In urology and kidneys
- In endocrine surgery
Show all 17Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Russia16 sites, 16 recruiting
- Recruiting
The First City Clinical Hospital. n.a. E. E. Volosevich
Arkhangelsk
Mikhail Kirov, MD
Mikhail Kirov, MD
- Recruiting
Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky
Kemerovo
Evgeny Grigoriev
Evgeny Grigoriev, MD
- Recruiting
Regional clinical hospital №2
Krasnodar, 350012
Nikita Trembach, PhD, nikitkax@mail.ru
Nikita Trembach, PhD
- Recruiting
Kuban State Medical University
Krasnodar, 350063
Igor Zabolotskikh, pobeda_zib@mail.ru
Igor Zabolotskikh, MD
- Not yet recruiting
Krasnodar regional hospital №2 (Kuban State Medical University)
Krasnodar
Igor Zabolotskikh, MD
Igor Zabolotskikh, MD
- Recruiting
Regional clinical hospital
Krasnoyarsk
Alexey Gritsan
Alexey Gritsan, MD
- Recruiting
Federal research and clinical center of intensive care medicine and rehabilitology
Moscow
Artem Kuzovlev
Kuzovlev Kuzovlev, MD
- Not yet recruiting
Loginov Moscow Clinical Scientific Center
Moscow
Valeriy Subbotin, MD
Valeriy Subbotin, MD
- Not yet recruiting
Military Medical Academy
Moscow
Alexey Shchegolev, MD
Alexey Shchegolev, MD
- Recruiting
Moscow cancer research Institute named after P. A. Herzen
Moscow
Victoria Khoronenko, MD, khoronenko_mnioi@mail.ru
Victoria Khoronenko, MD
- Not yet recruiting
Moscow Regional Research and Clinical Institute, Moscow, Russia
Moscow
Efim Shifman, MD
Efim Shifman, MD
- Recruiting
Moscow regional research clinical Institute named after M. F. Vladimirsky
Moscow
Alexey Ovezov, MD, amolex@mail.ru
Alexey Ovezov, MD
- Recruiting
Orenburg City N.I. Pirogov Clinical Hospital
Orenburg
Vadim Ershov
Vadim Ershov, MD
- Not yet recruiting
North-Western State Medical University named after Ilya I. Mechnikov,
Saint Petersburg
Konstantin Lebedinsii, MD
Konstantin Lebedinsii, MD
- Recruiting
Regional clinical hospital №2
Vladivostok
Pavel Dunts, PhD, dpv@bk.ru
Pavel Dunts, PhD
- Recruiting
Clinical city hospital № 40
Yekaterinburg
Andrey Belkin, MD
Andrey Belkin, MD
About this study
Official title: National Register of Postoperative Outcomes in the Russian Federation: a Multicenter Observational Study
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.
Read the detailed description
Currently, the incidence of perioperative complications and mortality associated with surgical intervention are minimized. However, taking into account the significant number of surgical interventions performed worldwide (more than 300 million per year), the total number of patients with complicated postoperative periods is large, and postoperative mortality ranks third in the structure of causes of death (7, 7%), second only to coronary heart disease and stroke. Moreover, even in discharged patients, complications that develop can significantly reduce quality of life and worsen long-term prognosis. To a greater extent, the above applies to high-risk patients, whose identification is a priority task of anesthesiology.
Identification of risk factors that cause a high probability of an unfavorable outcome is currently unthinkable without conducting comprehensive prospective population-based studies, which, on the one hand, make it possible to assess the contribution of many variables to the risk of complications and mortality, and on the other hand, to maximally cover a certain population by identifying characteristic predictors for it. To date, several population-based studies and programs have been described in the literature that have led to the creation of national databases (registries) of postoperative outcomes. Such studies include several international (ISOS, EuSOS and ASOS) and national ones, such as SweSOS [8] or ColSOS , which are at different stages of implementation. Among the national databases, the best known is the ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program) database, which contains information on the outcomes of surgical treatment for more than 5 million patients in the United States since 1991 .
The results obtained from these studies often vary widely, due to the diversity of approaches to study inclusion criteria, differences in the characteristics of the populations studied, and the lack of a uniform view on the classification of postoperative outcomes. When assessing mortality, the authors most often record 30-day mortality, however, taking into account modern ideas about the role of perioperative factors and complications in the development of an unfavorable long-term outcome, the need to determine one-year mortality becomes obvious. As shown by the national observational study SweSOS, the mortality rate increases significantly over time, with 30-day mortality being 1.8%, 3-month mortality - 3.9%, and 6-month and annual mortality - 5.0% and 8.5% , respectively .
There is also no uniform approach to the registration of postoperative complications, and modern protocols use several systems, the most common of which are the classification of the joint working group of ESA (The European Society of Anesthesiologists) and ESICM (The European Society of Intensive Care Medicine, The European). Society of Intensive Care Medicine) and the ACS-NSQIP classification (The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP)). And although they are similar in many ways (complications are grouped into blocks according to the nature of the disorders), differences are also present, and even the same complication may have a different definition. In addition, some significant outcomes are not included in these classifications, which predetermines their underestimation.
Of course, one of the advantages of creating a large population-based database is the recording of a large number of potential predictors of adverse outcome and subsequent assessment of their individual contribution to the complex perioperative risk. The type of surgical intervention itself is a factor that largely determines the likelihood of complications.
The goal is to create a Russian national calculator for the risk of postoperative complications and mortality.
Primary target points:
- Creation of a national register of postoperative outcomes in different areas of surgery.
- Determination of the frequency and structure of outcomes after elective and emergency surgery.
- Identification of predictors of unfavorable outcome.
- Development and validation of a model for predicting complications and mortality in various areas of surgery
- Creation of calculators for the risk of postoperative complications and mortality in various fields of surgery and their integration into a single calculator
- Analysis of long-term results in patients with postoperative complications (90 days and a year after surgery)
Secondary target points:
- The role of concomitant diseases in the development of unfavorable outcome
- The influence of age on primary and secondary postoperative outcomes
- The influence of the type of anesthesia on the course of the postoperative period
- The influence of oncological pathology and specific treatment on primary and secondary postoperative outcomes
- The impact of the urgency of surgery on the risk of an unfavorable outcome
- Influence of localization, access and duration of surgery on postoperative outcome
- Assessment and validation of surgical and anesthesiological risk scales for lethal outcome (can be listed)
- Evaluation and validation of surgical and anesthetic risk scales for primary and secondary outcomes
- Stratification of patients at high perioperative risk with details on cardiac, respiratory, neurological, renal, hepatic, hemostasiological, infectious and others.
- Influence of quality criteria for implementation of FAR recommendations on the course of the postoperative period
- Analysis of the course of ICU-syndrome in patients with complications and depending on the maximum score on the SOFA scale and the structure of MOF in the postoperative period
- Analysis of the effectiveness of rehabilitation measures in patients with ICU-syndrome
- Analysis of the causes of mortality (based on autopsy reports and clinical and laboratory data of patients).
Cohort A
The checklist (basic) is filled out for all patients with postoperative complications. At the same time, the total number of patients operated on in a particular center is taken into account on a quarterly basis, taking into account their distribution by area of surgery. Based on the data from the basic checklist, answers will be received to the following target points:
- Creation of a national register of postoperative outcomes in different areas of surgery.
- Determination of the frequency and structure of outcomes after planned and emergency surgical interventions.
- Analysis of long-term results in patients with postoperative complications (90 days and a year after surgery)
- Analysis of the course of ICU-syndrome in patients with complications and depending on the maximum score on the scale and the structure of MOF in the postoperative period
- Analysis of the effectiveness of rehabilitation measures in patients with ICU syndrome
Cohort B Basic checklist plus additional checklist: completed for all operated patients within one selected week quarterly The total number of patients operated on in a particular center is also taken into account quarterly, taking into account their distribution by area of surgery.
Based on the data from the basic and additional checklists, answers to the most important target points (3 primary and 10 secondary) will be obtained:
- Identification of predictors of unfavorable outcome.
- Development and validation of a model for predicting complications and mortality in various fields of surgery
- Creation of calculators for the risk of postoperative complications and mortality in various fields of surgery and their integration into a single calculator
- The role of concomitant diseases in the development of unfavorable outcome
- The influence of age on primary and secondary postoperative outcomes
- The influence of the type of anesthesia on the course of the postoperative period
- The influence of oncological pathology and specific treatment on primary and secondary postoperative outcomes
- The impact of the urgency of surgery on the risk of an unfavorable outcome
- The influence of localization, access and duration of surgery on postoperative outcome
- Assessment and validation of surgical and anesthesiological risk scales for lethal outcome (can be listed)
- Evaluation and validation of surgical and anesthetic risk scales for primary and secondary outcomes
- Stratification of patients at high perioperative risk with details on cardiac, respiratory, neurological, renal, hepatic, hemostasiological, infectious and others.
- Influence of quality criteria for implementation of FAR recommendations on the course of the postoperative period
- Conditions
- Surgery, Anesthesia, Outcome, Fatal, Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mortality
Incidence of postoperative death defined as any death occurring during and up to 30 days after surgery
Measured: 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
Measured: up to 30 days after surgery
Secondary outcomes (8)
Length of stay in the ICU
Number of days in the ICU
Measured: up to 30 days after surgery
Length of hospital stay
Number of days in the hospital
Measured: up to 30 days after surgery
Multiple organ failure (2 or more points on the SOFA (Sequential Organ Failure Assessment) scale)
Incidence of MOF
Measured: up to 30 days after surgery
90-days mortality
Incidence of postoperative death defined as any death occurring during and up to 90 days after anaesthesia
Measured: up to 90 days after surgery
90-days 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 PE 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
Measured: up to 90 days after surgery
ICU - syndrome
The intensive care unit (ICU) syndrome is a type of organic brain syndrome manifested by a variety of psychological reactions, including fear, anxiety, depression, hallucinations, and delirium.
Measured: up to 90 days after surgery
Readmission
Any readmission to the hospital
Measured: up to 1 year after surgery
1-year mortality
Incidence of death defined as any death occurring during and up to 1 year after surgery
Measured: up to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start9 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Federation of Anesthesiologists and Reanimatologists
- Sponsor type
- University, hospital or other
- Collaborators
- Kuban State Medical University
- Responsible party
- Sponsor
- Investigators
- Igor Zabolotskikh, MD, Study chair, Kuban State Medical UniversityNikita Trembach, MD, Study director, Kuban State Medical UniversityAndrey Belkin, MD, Study director, Clinical Institute of BrainEvgeniy Grigiriev, MD, Study director, Research Institute for Complex Issues of Cardiovascular DiseasesAlexei Gritsan, MD, Study director, Voino-Yasenetsky Krasnoyarsk State Medical UniversityPavel Dunts, PhD, Study director, Pacific State Medical UniversityVadim Ershov, MD, Study director, Orenburg State Medical UniversityMikhail Kirov, MD, Study director, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146270
- Sponsor's protocol ID
- FARCT0005
- Acronym
- RuSOS
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No