跳至主要内容
临床试验/NCT06146270
NCT06146270招募中不适用

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

Russian Federation of Anesthesiologists and Reanimatologists15 个研究点 分布在 1 个国家目标入组 162,000 人开始时间: 2025年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
162,000
试验地点
15
主要终点
Postoperative mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age 18 years and older) undergoing elective surgery:
  • In obstetrics
  • In gynecology
  • 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).

排除标准

  • 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

结局指标

主要结局

Postoperative mortality

时间窗: up to 30 days after surgery

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

Postoperative complications

时间窗: up to 30 days after surgery

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

次要结局

  • 90-days mortality(up to 90 days after surgery)
  • 1-year mortality(up to 1 year after surgery)
  • ICU - syndrome(up to 90 days after surgery)
  • 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 postoperative complications(up to 90 days after surgery)
  • Readmission(up to 1 year after surgery)

研究者

发起方
Russian Federation of Anesthesiologists and Reanimatologists
申办方类型
Other
责任方
Sponsor

研究点 (15)

Loading locations...

相似试验