The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.

NCT03945968 | Recruiting

• 1 other identifier: FARCT0001
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 38

Brief Summary

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.

Conditions

Coronary Heart Disease; Anemia; Bronchial Asthma; Stroke; Epilepsy; Parkinson's Disease; Heart Rhythm Disorders; Alzheimer's Disease; Neuromuscular Diseases; Diabetes; Chronic Heart Failure; Chronic Obstructive Pulmonary Disease; Chronic Kidney Diseases

Keywords

anesthesia; concomitant diseases; risk stratification

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative complications

  Postoperative complications (according to the definitions of ESA-SCICM, 2015) 1. Acute kidney damage 2. ARDS 3. The failure of the anastomose 4. Arrhythmias 5. Cardiac arrest 6. Cardiogenic pulmonary edema 7. Postoperative delirium 8. Myocardial infarction 9. Pneumonia 10. Paresis of the intestine 11. Postoperative bleeding 12. Pulmonary thromboembolism 13. Stroke 14. Wound infection NSQIP complications: 1. Acute respiratory failure 2. Unplanned reintubation 3. Sepsis/septic shock 4. Wound dehiscence 5. Postoperative transfusion

  7 days after surgery

Secondary Outcomes (1)

• mortality after abdominal surgery

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult atients undergoing an abdominal surgery in study centers

You may qualify if:

• surgical interventions on the abdominal organs,
• ASA physical status class

You may not qualify if:

• the inability to assess the factors included in the study,
• acute massive blood loss, aspiration,
• bronchospasm,
• anaphylactic reactions,
• malignant hyperthermia

Sponsors & Collaborators

• Russian Federation of Anesthesiologists and Reanimatologists: lead
• Kuban State Medical University: collaborator

Study Sites (38)

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, 650002, Russia

RECRUITING

Regional clinical hospital №2

Krasnodar, 350012, Russia

RECRUITING

Kuban State Medical University

Krasnodar, 350063, 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, 660022, Russia

RECRUITING

Burnasyan federal medical biophysical center of federal medical biological agency

Moscow, 123098, 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

Related Publications (12)

• Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2017 Sep 1;119(3):553. doi: 10.1093/bja/aew472. No abstract available.

  PMID: 28498884 BACKGROUND

• Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Size and distribution of the global volume of surgery in 2012. Bull World Health Organ. 2016 Mar 1;94(3):201-209F. doi: 10.2471/BLT.15.159293.

  PMID: 26966331 BACKGROUND

• Gawande AA, Thomas EJ, Zinner MJ, Brennan TA. The incidence and nature of surgical adverse events in Colorado and Utah in 1992. Surgery. 1999 Jul;126(1):66-75. doi: 10.1067/msy.1999.98664.

  PMID: 10418594 BACKGROUND

• Kable AK, Gibberd RW, Spigelman AD. Adverse events in surgical patients in Australia. Int J Qual Health Care. 2002 Aug;14(4):269-76. doi: 10.1093/intqhc/14.4.269.

  PMID: 12201185 BACKGROUND

• Malik OS, Brovman EY, Urman RD. The Use of Regional or Local Anesthesia for Carotid Endarterectomies May Reduce Blood Loss and Pulmonary Complications. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):935-942. doi: 10.1053/j.jvca.2018.08.195. Epub 2018 Aug 23.

  PMID: 30243870 BACKGROUND

• Young J, Badgery-Parker T, Dobbins T, Jorgensen M, Gibbs P, Faragher I, Jones I, Currow D. Comparison of ECOG/WHO performance status and ASA score as a measure of functional status. J Pain Symptom Manage. 2015 Feb;49(2):258-64. doi: 10.1016/j.jpainsymman.2014.06.006. Epub 2014 Jul 1.

  PMID: 24996034 BACKGROUND

• Whiteley MS, Prytherch DR, Higgins B, Weaver PC, Prout WG. An evaluation of the POSSUM surgical scoring system. Br J Surg. 1996 Jun;83(6):812-5. doi: 10.1002/bjs.1800830628.

  PMID: 8696749 BACKGROUND

• Watt J, Tricco AC, Talbot-Hamon C, Pham B, Rios P, Grudniewicz A, Wong C, Sinclair D, Straus SE. Identifying older adults at risk of harm following elective surgery: a systematic review and meta-analysis. BMC Med. 2018 Jan 12;16(1):2. doi: 10.1186/s12916-017-0986-2.

  PMID: 29325567 BACKGROUND

• Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

  PMID: 15616043 BACKGROUND

• 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.

  PMID: 21709059 BACKGROUND

• Hachenberg T, Schneemilch C. Anesthesia in neurologic and psychiatric diseases: is there a 'best anesthesia' for certain diseases? Curr Opin Anaesthesiol. 2014 Aug;27(4):394-402. doi: 10.1097/ACO.0000000000000098.

  PMID: 24979067 BACKGROUND

• Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

  PMID: 22998715 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, white cells, albumin, erythrocytes, thromocytes

MeSH Terms

Conditions

Coronary Disease; Anemia; Asthma; Stroke; Epilepsy; Parkinson Disease; Arrhythmias, Cardiac; Alzheimer Disease; Neuromuscular Diseases; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Igor Zabolotskikh, MD

  Russian Federation of Anesthesiologists and Reanimatologists

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikita Trembach, PhD

CONTACT

+79528589299; nikitkax@mail.ru

Igor Zabolotskikh, MD

CONTACT

pobeda_zib@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of guidelines and clinical stгdies commettee

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 10, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (38)