Assessing the impact of comorbidities on postoperative complications.
The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study
This study looks at how having other health issues affects the chances of complications after abdominal surgery to help doctors better understand and manage risks for their patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Russian Federation of Anesthesiologists and Reanimatologists Academic / other |
| Locations | 38 sites (Arkhangelsk and 37 other locations) |
| Trial ID | NCT03945968 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence and structure of comorbidities among patients undergoing abdominal surgery. It seeks to stratify the risk of postoperative complications by identifying independent predictors that contribute to these risks. By analyzing a large cohort of surgical patients, the study will provide insights into how concomitant diseases affect surgical outcomes and mortality rates. The findings could help in developing better risk assessment tools for anesthesiologists and surgeons.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for abdominal surgery with an ASA physical status class of 1-3.
Not a fit: Patients with acute conditions such as massive blood loss, bronchospasm, or anaphylactic reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of patients undergoing surgery, potentially reducing postoperative complications.
How similar studies have performed: Previous studies have indicated the importance of comorbidities in surgical outcomes, suggesting that this approach has been validated in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * surgical interventions on the abdominal organs, * 1-3 ASA physical status class Exclusion Criteria: * the inability to assess the factors included in the study, * acute massive blood loss, aspiration, * bronchospasm, * anaphylactic reactions, * malignant hyperthermia
Where this trial is running
Arkhangelsk and 37 other locations
- The First City Clinical Hospital. n.a. E. E. Volosevich — Arkhangelsk, Russia (Recruiting)
- Astrakhan State Medical University — Astrakhan, Russia (Recruiting)
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine — Chelyabinsk, Russia (Recruiting)
- South-Ural State Medical University — Chelyabinsk, Russia (Recruiting)
- Chita state medical Academy of the Ministry of health of the Russian Federation — Chita, Russia (Recruiting)
- Kazan State Medical University — Kazan', Russia (Recruiting)
- Republic Clinical Hospital Ministry of Health care of the Republic of Tatarstan — Kazan', Russia (Recruiting)
- Research Institute for Complex Issues of Cardiovascular Diseases — Kemerovo, Russia (Recruiting)
- Regional clinical hospital №2 — Krasnodar, Russia (Recruiting)
- Kuban State Medical University — Krasnodar, Russia (Recruiting)
- Research Institute Regional Clinical Hospital named after S.V. Ochapovsky — Krasnodar, Russia (Recruiting)
- Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky — Krasnoyarsk, Russia (Recruiting)
- Burnasyan federal medical biophysical center of federal medical biological agency — Moscow, Russia (Recruiting)
- City clinical hospital named after S.S. Yudin — Moscow, Russia (Recruiting)
- City clinical hospital №1 named after N.I. Pirogov — Moscow, Russia (Recruiting)
- City Clinical Hospital. n.a. F.I. Inozemtseva — Moscow, Russia (Recruiting)
- FGBU "Central clinical hospital with polyclinic" of the President administration of the Russian Federation — Moscow, Russia (Recruiting)
- Moscow cancer research Institute named after P. A. Herzen — Moscow, Russia (Recruiting)
- Moscow City Oncological Hospital № 62 — Moscow, Russia (Recruiting)
- Moscow regional research clinical Institute named after M. F. Vladimirsky — Moscow, Russia (Recruiting)
- National Medical and Surgical Center named after N.I. Pirogov — Moscow, Russia (Recruiting)
- Privolzhsky district medical center — Nizhny Novgorod, Russia (Recruiting)
- State Novosibirsk Regional Clinical Hospital — Novosibirsk, Russia (Recruiting)
- Orenburg Regional Clinical Hospital — Orenburg, Russia (Recruiting)
- "Republican hospital named after V. A. Baranov" — Petrozavodsk, Russia (Recruiting)
- Rostov State Medical University — Rostov-on-Don, Russia (Recruiting)
- North-West State Medical University named after I.I.Mechnikov — Saint Petersburg, Russia (Recruiting)
- St. Petersburg state budgetary healthcare institution " City clinical Oncology dispensary" — Saint Petersburg, Russia (Recruiting)
- "Samara Regional Clinical Oncology Dispensary" — Samara, Russia (Recruiting)
- Clinical Hospital named after SR. Mirotvortseva (FGBOU VO "Saratov State Medical University. n.a. V.I.Razumovsky" Ministry of Health of the Russian Federation — Saratov, Russia (Recruiting)
- Stavropol regional clinical hospital — Stavropol, Russia (Recruiting)
- Regional Clinical Hospital No. 1 — Tyumen, Russia (Not_yet_recruiting)
- Regional clinical hospital №2 — Vladivostok, Russia (Recruiting)
- Emergency hospital — Volgograd, Russia (Recruiting)
- Volgograd regional clinical hospital — Volgograd, Russia (Recruiting)
- Yakut Republican Oncological Dispensary — Yakutsk, Russia (Recruiting)
- Ekaterinburg City clinical hospital № 40 — Yekaterinburg, Russia (Recruiting)
- Sverdlovsk regional clinicl hospital №1 — Yekaterinburg, Russia (Recruiting)
Study contacts
- Principal investigator: Igor Zabolotskikh, MD — Russian Federation of Anesthesiologists and Reanimatologists
- Study coordinator: Nikita Trembach, PhD
- Email: nikitkax@mail.ru
- Phone: +79528589299
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.