Russian Registry of Surgical OutcomeS
Recruiting now
Conditions studied: Surgery, Anesthesia, Outcome, Fatal, Complication
In brief
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.
Key facts
- Study ID
- NCT06146270
- Run by
- Russian Federation of Anesthesiologists and Reanimatologists
- People needed
- 162000
- Starts
- 2025-01-09
- Expected to finish
- 2029-01-31
- Last updated by the study team
- 2025-04-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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).
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
Where it is running
- The First City Clinical Hospital. n.a. E. E. Volosevich — Arkhangelsk, Russia (enrolling)
- Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky — Kemerovo, Russia (enrolling)
- Regional clinical hospital №2 — Krasnodar, Russia (enrolling)
- Kuban State Medical University — Krasnodar, Russia (enrolling)
- Moscow cancer research Institute named after P. A. Herzen — Moscow, Russia (enrolling)
- Moscow regional research clinical Institute named after M. F. Vladimirsky — Moscow, Russia (enrolling)
- Orenburg City N.I. Pirogov Clinical Hospital — Orenburg, Russia (enrolling)
- Regional clinical hospital №2 — Vladivostok, Russia (enrolling)
- Clinical city hospital № 40 — Yekaterinburg, Russia (enrolling)
- Regional clinical hospital — Krasnoyarsk, Russia (enrolling)
- Federal research and clinical center of intensive care medicine and rehabilitology — Moscow, Russia (enrolling)
- Krasnodar regional hospital №2 (Kuban State Medical University) — Krasnodar, Russia
- North-Western State Medical University named after Ilya I. Mechnikov, — Saint Petersburg, Russia
- Moscow Regional Research and Clinical Institute, Moscow, Russia — Moscow, Russia
- Loginov Moscow Clinical Scientific Center — Moscow, Russia
- Military Medical Academy — Moscow, Russia
Full record on ClinicalTrials.gov
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