National registry for surgical outcomes in Russia
National Register of Postoperative Outcomes in the Russian Federation: a Multicenter Observational Study
This study is trying to find out what factors lead to problems after surgery by collecting information from adult patients in Russia who have had different types of surgeries, so they can improve safety and outcomes for future patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 162000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Russian Federation of Anesthesiologists and Reanimatologists Academic / other |
| Locations | 16 sites (Arkhangelsk and 15 other locations) |
| Trial ID | NCT06146270 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify risk factors associated with unfavorable postoperative outcomes by creating a national database of surgical patients in Russia. It will involve a multicenter approach, collecting data from adult patients undergoing both elective and emergency surgeries across various specialties. The study seeks to develop a risk calculator for postoperative complications and mortality, enhancing the understanding of predictors that contribute to adverse outcomes. By analyzing a comprehensive dataset, the study aims to improve patient safety and surgical practices.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older who are undergoing elective or emergency surgical procedures.
Not a fit: Patients who do not meet the inclusion criteria, such as those lacking informed consent or those undergoing procedures without an anesthesiologist, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of high-risk patients and better management of surgical outcomes.
How similar studies have performed: Previous international and national registries have shown success in identifying risk factors and improving surgical outcomes, indicating that this approach is supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Arkhangelsk and 15 other locations
- 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, Russia (Recruiting)
- Kuban State Medical University — Krasnodar, 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 contacts
- Study coordinator: Igor Zabolotskikh, MD
- Email: pobeda_zib@mail.ru
- Phone: +79183883499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.