Clinical trial NCT06146270: Russian Registry of Surgical OutcomeS
Official title: National Register of Postoperative Outcomes in the Russian Federation: a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Anesthesia
Outcome, Fatal
Complication
Lead sponsor: Russian Federation of Anesthesiologists and Reanimatologists
Sponsor class: OTHER
Collaborators: name: Kuban State Medical University
First posted: 2023-11-24
Enrollment: 162000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing surgery in various areas of surgery

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.

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:

1. Creation of a national register of postoperative outcomes in different areas of surgery.
2. Determination of the frequency and structure of outcomes after elective and emergency surgery.
3. Identification of predictors of unfavorable outcome.
4. Development and validation of a model for predicting complications and mortality in various areas of surgery
5. Creation of calculators for the risk of postoperative complications and mortality in various fields of surgery and their integration into a single calculator
6. Analysis of long-term results in patients with postoperative complications (90 days and a year after surgery)

Secondary target points:

1. The role of concomitant diseases in the development of unfavorable outcome
2. The influence of age on primary and secondary postoperative outcomes
3. The influence of the type of anesthesia on the course of the postoperative period
4. The influence of oncological pathology and specific treatment on primary and secondary postoperative outcomes
5. The impact of the urgency of surgery on the risk of an unfavorable outcome
6. Influence of localization, access and duration of surgery on postoperative outcome
7. Assessment and validation of surgical and anesthesiological risk scales for lethal outcome (can be listed)
8. Evaluation and validation of surgical and anesthetic risk scales for primary and secondary outcomes
9. Stratification of patients at high perioperative risk with details on cardiac, respiratory, neurological, renal, hepatic, hemostasiological, infectious and others.
10. Influence of quality criteria for implementation of FAR recommendations on the course of the postoperative period
11. 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
12. Analysis of the effectiveness of rehabilitation measures in patients with ICU-syndrome
13. 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:

1. Creation of a national register of postoperative outcomes in different areas of surgery.
2. Determination of the frequency and structure of outcomes after planned and emergency surgical interventions.
3. Analysis of long-term results in patients with postoperative complications (90 days and a year after surgery)
4. 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
5. 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:

1. Identification of predictors of unfavorable outcome.
2. Development and validation of a model for predicting complications and mortality in various fields of surgery
3. Creation of calculators for the risk of postoperative complications and mortality in various fields of surgery and their integration into a single calculator
4. The role of concomitant diseases in the development of unfavorable outcome
5. The influence of age on primary and secondary postoperative outcomes
6. The influence of the type of anesthesia on the course of the postoperative period
7. The influence of oncological pathology and specific treatment on primary and secondary postoperative outcomes
8. The impact of the urgency of surgery on the risk of an unfavorable outcome
9. The influence of localization, access and duration of surgery on postoperative outcome
10. Assessment and validation of surgical and anesthesiological risk scales for lethal outcome (can be listed)
11. Evaluation and validation of surgical and anesthetic risk scales for primary and secondary outcomes
12. Stratification of patients at high perioperative risk with details on cardiac, respiratory, neurological, renal, hepatic, hemostasiological, infectious and others.
13. Influence of quality criteria for implementation of FAR recommendations on the course of the postoperative period

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

1. Lack of informed consent from the patient
2. Complications associated with the manipulations of an anesthesiologist
3. Interventions without the participation of an anesthesiologist-resuscitator
4. Incomplete checklists
5. Errors when filling checklists
6. Deviations from the Register protocol

Primary outcomes:
measure: Postoperative mortality
timeFrame: up to 30 days after surgery
measure: Postoperative complications
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Length of stay in the ICU
timeFrame: up to 30 days after surgery
measure: Length of hospital stay
timeFrame: up to 30 days after surgery
measure: Multiple organ failure (2 or more points on the SOFA (Sequential Organ Failure Assessment) scale)
timeFrame: up to 30 days after surgery
measure: 90-days mortality
timeFrame: up to 90 days after surgery
measure: 90-days postoperative complications
timeFrame: up to 90 days after surgery
measure: ICU - syndrome
timeFrame: up to 90 days after surgery
measure: Readmission
timeFrame: up to 1 year after surgery
measure: 1-year mortality
timeFrame: up to 1 year after surgery
Other outcomes:
Locations:
city: Arkhangel'sk
country: Russian Federation
facility: The First City Clinical Hospital. n.a. E. E. Volosevich
city: Ekaterinburg
country: Russian Federation
facility: Clinical city hospital № 40
city: Kemerovo
country: Russian Federation
facility: Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky
city: Krasnodar
country: Russian Federation
facility: Regional clinical hospital №2
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University
city: Krasnodar
country: Russian Federation
facility: Krasnodar regional hospital №2 (Kuban State Medical University)
city: Krasnoyarsk
country: Russian Federation
facility: Regional clinical hospital
city: Moscow
country: Russian Federation
facility: Federal research and clinical center of intensive care medicine and rehabilitology
city: Moscow
country: Russian Federation
facility: Loginov Moscow Clinical Scientific Center
city: Moscow
country: Russian Federation
facility: Military Medical Academy
city: Moscow
country: Russian Federation
facility: Moscow cancer research Institute named after P. A. Herzen
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute, Moscow, Russia
city: Moscow
country: Russian Federation
facility: Moscow regional research clinical Institute named after M. F. Vladimirsky
city: Orenburg
country: Russian Federation
facility: Orenburg City N.I. Pirogov Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: North-Western State Medical University named after Ilya I. Mechnikov,
city: Vladivostok
country: Russian Federation
facility: Regional clinical hospital №2
Study officials:
affiliation: Kuban State Medical University
name: Igor Zabolotskikh, MD
role: STUDY_CHAIR
affiliation: Kuban State Medical University
name: Nikita Trembach, MD
role: STUDY_DIRECTOR
affiliation: Clinical Institute of Brain
name: Andrey Belkin, MD
role: STUDY_DIRECTOR
affiliation: Research Institute for Complex Issues of Cardiovascular Diseases
name: Evgeniy Grigiriev, MD
role: STUDY_DIRECTOR
affiliation: Voino-Yasenetsky Krasnoyarsk State Medical University
name: Alexei Gritsan, MD
role: STUDY_DIRECTOR
affiliation: Pacific State Medical University
name: Pavel Dunts, PhD
role: STUDY_DIRECTOR
affiliation: Orenburg State Medical University
name: Vadim Ershov, MD
role: STUDY_DIRECTOR
affiliation: Northern State Medical University
name: Mikhail Kirov, MD
role: STUDY_DIRECTOR
affiliation: Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
name: Artem Kuzovlev, MD
role: STUDY_DIRECTOR
affiliation: Ural State Medical University
name: Alexandr Kulikov, MD
role: STUDY_DIRECTOR
affiliation: Moscow Regional Research and Clinical Institute
name: Alexey Ovezov, MD
role: STUDY_DIRECTOR
affiliation: Pirogov Russian National Research Medical University
name: Denis Protsenko, MD
role: STUDY_DIRECTOR
affiliation: Loginov Moscow Clinical Scientific Center
name: Valeriy Subbotin, MD
role: STUDY_DIRECTOR
affiliation: P. A. Hertsen Moscow Oncology Research Center
name: Victoria Khoronenko, MD
role: STUDY_DIRECTOR
affiliation: Moscow Regional Research and Clinical Institute, Moscow, Russia
name: Efim Shifman, MD
role: STUDY_DIRECTOR
affiliation: Military Medical Academy, Bulgaria
name: Alexey Shchegolev, MD
role: STUDY_DIRECTOR
affiliation: North-Western State Medical University named after Ilya I. Mechnikov
name: Konstantin Lebedinskii, MD
role: STUDY_DIRECTOR
References: