Stroke Clinical Trial
— STOPRISKOfficial title:
The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study
NCT number | NCT03945968 |
Other study ID # | FARCT0001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | February 28, 2025 |
Study is conducted to assess the prevalence and structure of comorbidity among patients undergoing abdominal surgery and produce the stratification of the risk of postoperative complications by identifying independent predictors for its development.
Status | Recruiting |
Enrollment | 16000 |
Est. completion date | February 28, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | The First City Clinical Hospital. n.a. E. E. Volosevich | Arkhangel'sk | |
Russian Federation | Astrakhan State Medical University | Astrakhan | |
Russian Federation | Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine | Chelyabinsk | |
Russian Federation | South-Ural State Medical University | Chelyabinsk | |
Russian Federation | Chita state medical Academy of the Ministry of health of the Russian Federation | Chita | |
Russian Federation | Ekaterinburg City clinical hospital ? 40 | Ekaterinburg | |
Russian Federation | Sverdlovsk regional clinicl hospital ?1 | Ekaterinburg | |
Russian Federation | Kazan State Medical University | Kazan | |
Russian Federation | Republic Clinical Hospital Ministry of Health care of the Republic of Tatarstan | Kazan | |
Russian Federation | Research Institute for Complex Issues of Cardiovascular Diseases | Kemerovo | |
Russian Federation | Kuban State Medical University | Krasnodar | |
Russian Federation | Regional clinical hospital ?2 | Krasnodar | |
Russian Federation | Research Institute Regional Clinical Hospital named after S.V. Ochapovsky | Krasnodar | |
Russian Federation | Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky | Krasnoyarsk | |
Russian Federation | Burnasyan federal medical biophysical center of federal medical biological agency | Moscow | |
Russian Federation | City clinical hospital ?1 named after N.I. Pirogov | Moscow | |
Russian Federation | City clinical hospital named after S.S. Yudin | Moscow | |
Russian Federation | City Clinical Hospital. n.a. F.I. Inozemtseva | Moscow | |
Russian Federation | FGBU "Central clinical hospital with polyclinic" of the President administration of the Russian Federation | Moscow | |
Russian Federation | Moscow cancer research Institute named after P. A. Herzen | Moscow | |
Russian Federation | Moscow City Oncological Hospital ? 62 | Moscow | |
Russian Federation | Moscow regional research clinical Institute named after M. F. Vladimirsky | Moscow | |
Russian Federation | National Medical and Surgical Center named after N.I. Pirogov | Moscow | |
Russian Federation | Privolzhsky district medical center | Nizhny Novgorod | |
Russian Federation | State Novosibirsk Regional Clinical Hospital | Novosibirsk | |
Russian Federation | Orenburg Regional Clinical Hospital | Orenburg | |
Russian Federation | "Republican hospital named after V. A. Baranov" | Petrozavodsk | |
Russian Federation | Rostov State Medical University | Rostov-on-Don | |
Russian Federation | North-West State Medical University named after I.I.Mechnikov | Saint Petersburg | |
Russian Federation | St. Petersburg state budgetary healthcare institution " City clinical Oncology dispensary" | Saint Petersburg | |
Russian Federation | "Samara Regional Clinical Oncology Dispensary" | Samara | |
Russian Federation | 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 | |
Russian Federation | Stavropol regional clinical hospital | Stavropol' | |
Russian Federation | Regional Clinical Hospital No. 1 | Tyumen | |
Russian Federation | Regional clinical hospital ?2 | Vladivostok | |
Russian Federation | Emergency hospital | Volgograd | |
Russian Federation | Volgograd regional clinical hospital | Volgograd | |
Russian Federation | Yakut Republican Oncological Dispensary | Yakutsk |
Lead Sponsor | Collaborator |
---|---|
Russian Federation of Anesthesiologists and Reanimatologists | Kuban State Medical University |
Russian Federation,
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van Diepen S, Bakal JA, McAlister FA, Ezekowitz JA. Mortality and readmission of patients with heart failure, atrial fibrillation, or coronary artery disease undergoing noncardiac surgery: an analysis of 38 047 patients. Circulation. 2011 Jul 19;124(3):289-96. doi: 10.1161/CIRCULATIONAHA.110.011130. Epub 2011 Jun 27. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of postoperative complications | Postoperative complications (according to the definitions of ESA-SCICM, 2015)
Acute kidney damage ARDS The failure of the anastomose Arrhythmias Cardiac arrest Cardiogenic pulmonary edema Postoperative delirium Myocardial infarction Pneumonia Paresis of the intestine Postoperative bleeding Pulmonary thromboembolism Stroke Wound infection NSQIP complications: Acute respiratory failure Unplanned reintubation Sepsis/septic shock Wound dehiscence Postoperative transfusion |
7 days after surgery | |
Secondary | mortality after abdominal surgery | 30-day mortality | 30 days |
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