The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.

Stroke Clinical Trial

— STOPRISK  

Official title:

The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03945968
• Other study ID #: FARCT0001
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Russian Federation of Anesthesiologists and Reanimatologists
• Contact: Nikita Trembach, PhD
• Phone: +79528589299
• Email: nikitkax[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Advances in modern anesthesiology have significantly reduced the risk of anesthesia compared to the last century, however, the level of perioperative hospital mortality of planned operations at the moment is on average about 0.5% (ISOS group, 2016). Weiser et al. (2016) estimated that more than 313 million adults worldwide are subject to surgery each year. Thus, the number of deaths may result in several million each year worldwide. However, the study of the mortality risk is associated with certain difficulties, because over the past half century, this figure has decreased a hundred times and the study requires studies that include a large number of participants.

Current research focuses on other outcome criteria - postoperative complications. Thus, anesthetic risk often refers to the risk of postoperative complications. The frequency of these complications varies in a wide range, ranging from 3 to 18 % (Gawande AA, 1999, Kable AK, 2002, Malik OS, 2018). The differences in the data are explained by the lack of clear definitions and differences in the design of studies, but the fact that the development of postoperative complications increases the risk of death several times (ISOS group, 2016) can be considered undoubted. However, despite the importance of this issue, in modern literature there is no clear idea of what is considered a high risk and which of the patients corresponds to this category.

Understanding whether a patient is at high risk is an essential task - it allows you to obtain meaningful informed consent of the patient, as well as to understand whether to apply strategies for the prevention of complications (targeted infusion therapy, protective respiratory support, especially monitoring in the postoperative period, etc.).

Attempts at preoperative risk stratification have been made for many decades, some scales estimate the initial physical status (ASA scale) (Young J, 2015) and predict mortality, others estimate the risk of specific complications (Lee index, respiratory risk scale, etc.) .

Scales including intraoperative and postoperative parameters such as the POSSUM series of scales (Whiteley MS, 1996) are also being developed. The analysis shows that in routine clinical practice, these scales are not used very often, due to their limitations: subjectivity, technical complexity and often - low specificity and sensitivity.

Concomitant diseases are the strongest predictors of postoperative adverse events and annual mortality. Monk et al. (2005) demonstrated that Charlson's comorbidity score of 3 or more significantly increased the risk of death. In addition, in most clinical studies, the ASAclassification of physical status as a kind of comprehensive assessment of patient comorbidity has repeatedly proved to be one of the strongest independent predictors of postoperative morbidity and mortality, despite the fact that this assessment is based on subjective perception (Watt J., 2018).

The main concomitant diseases that are independent predictors of perioperative complications are diseases of the cardiovascular and respiratory systems (Van Diepen S, 2011). Increasing age, anemia, obesity, diabetes - these conditions also increase the risk of an adverse outcome. Diseases of the Central nervous system and neuromuscular diseases significantly disrupt the function of respiration, can change the level of the Autonomous regulation of the cardiovascular system, lead to significant cognitive disorders and nutritional deficiency, which also increases the risk of perioperative complications (Hachenberg T, 2014).

On the other hand, large-scale observational studies conducted in recent years in a number of countries have not identified comorbidities as independent predictors of postoperative complications (Malik, 2018).

Thus, data on the risk effects of comorbidities are contradictory and may be influenced by differences in the frequency and structure of these diseases in heterogeneous populations, as well as in different treatment strategies for cardiovascular, respiratory and other diseases. The identification of these risk factors is necessary to understand the pathophysiology of complications and identify potential ways to reduce anesthetic risk, such as the correction of concomitant disease.

The degree of risk of surgery, of course, depends not only on the presence of comorbidities and their combinations, but also on the severity of surgical injury (Pearse RM, 2012, ISOS group, 2017), as well as the level of exposure to drugs for anesthesia and anesthetic techniques (Malik OS, 2018), therefore, the allocation of risk groups without these factors is also not appropriate.

Objective: to assess the frequency and structure of comorbidities in patients undergoing surgery on the abdominal organs and to stratify the risk of postoperative complications by determining independent

Evaluated parameters in study:

1. Age, gender; 2. Class of physical status by ASA; 3. The presence and type of concomitant disease; 3.1 CHD; 3.2 CHF; 3.3 Heart rhythm disorders; 3.4 COPD; 3.5 Bronchial Asthma; 3.6 CKD; 3.7 CNS diseases; 3.7.1 Stroke; 3.7.2 Epilepsy; 3.7.3 Parkinson's Disease; 3.7.4 Alzheimer's Disease; 3.8 Neuromuscular diseases; 3.9 Diabetes; 3.10 Anemia; 4 Treatment received by the patient; 4.1 β-blockers; 4.2 ACE Inhibitors; 4.3 Aldosterone antagonists; 4.4 Statins; 4.5 Anticoagulants; 4.6 Diuretics; 4.7 Bronchodilators; 4.8 Corticosteriods; 4.9 Insulin; 4.10 Anticonvulsants; 5. The type and severity of surgery ; 5.1 Open surgery on the organs of the upper abdomen; 5.2 Coloproctological operations; 5.3 Gynecological surgery; 5.4 Urological surgery; 5.5 Operations on vessels of the abdominal cavity; 5.6 Abdominal wall surgery; 5.7 Laparoscopic surgery; 6 Type of anesthesia; 6.1 Spinal; 6.2 Epidural; 6.3 Combined spinal-epidural; 6.4 Intravenous; 6.5 Combined; 6.6 General+epidural; 7. Integral scales; 7.1 The cognitive function of the Montreal scale ; 7.2 Respiratory risk ; 7.3 Lee's Cardiovascular Risk Scale ; 7.4 NSQIP Cardiac risk scale ; 7.5 Hepatic insufficiency according to MELD; 7.6 CKD Stage by Level of GFR and Albuminuria; 7.7 COPD degree by GOLD.

Order of conduct

1. The data is registered in the Excel electronic database in a uniform format for all centers (the form will be sent by the coordinator to all centers participating in the study prior to the inclusion of patients).

2. All centers need to get approval by the local ethics committee before the start of the study. The study protocol will be registered in Clinicaltrial.gov.

3. The study includes all patients operated on within one operational day at the discretion of the center and meeting the inclusion criteria with registration in the questionnaire of the day of the week.

4. All patients could sign informed consent to participate in the study prior to inclusion in the study.

5. Before surgery, data on the patient and all studied factors specified in the study protocol are entered into the database.

6. All patients included in the study are monitored before discharge from the hospital with registration of the data specified in the protocol.

6. Every last day of the working week, all completed cases are sent as a separate Excel file to the study coordinator by email to trembachnv@mail.ru 7. The originals of the questionnaires are stored in the centers for the entire study time and for 3 years after its completion.

8. The summary database is formed by the study coordinator and provided to the centers after the end of the study.

Statistical analysis The sample size was calculated taking into account the fact that at least 10 cases of postoperative complications per one factor included in the final regression model are required. Given the wide range of complication rates in previous studies (from 3% to 20%), we have chosen a lower bound for a more accurate assessment. To include 20 potential risk factors in the regression model, 200 cases of postoperative complications are required, which at a frequency of 3% is not less than 7000 people. Taking into account the risk of data loss, and taking into account as many potential risk factors as possible, the size of the required sample was increased to 12,000 people, which will also assess the contribution of comorbidities to certain groups of complications. For validation of predictive models will be recruited 4,000 additional. The inclusion of the patient in the main and validation group will be carried out randomly.

The character of distribution of studied parameters will be evaluated using the criterion Kolmogorov-Smirnov. The continuous data will be presented as the median and interquartile range for the nonparametric distribution and as the mean and standard deviation for the parametric distribution. Categorical variables will be presented as the number of patients and a percentage of the total number of patients.

For the initial assessment of the Association of the factor with postoperative complications, a single-factor analysis using the χ2 criterion and the Mann-Whitney test will be carried out. All variables with a reliable relationship identified in the univariate analysis (p less than 0.05) will be included in logistic regression if there is no collinearity between them (correlation coefficient less than 0.25). The logistic regression model will be constructed using a step-by-step reverse inclusion procedure in which the presence of a complication will be a dependent variable. Potential predictors will be removed if this exception does not cause a significant change in the log likelihood ratio. The criterion for excluding the factor will be set at the significance level of 0.05. Adjusted odds ratios and 95% confidence intervals will also be calculated.

The resulting predictive model will be evaluated in the validation group using ROC analysis and the Hosmer-Lemeshov test.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Anemia
• Arrhythmias, Cardiac
• Asthma
• Bronchial Asthma
• Chronic Heart Failure
• Chronic Kidney Diseases
• Chronic Obstructive Pulmonary Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes
• Epilepsy
• Heart Rhythm Disorders
• Kidney Diseases
• Lung Diseases, Obstructive
• Neuromuscular Diseases
• Parkinson Disease
• Parkinson's Disease
• Postoperative Complications
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic
• Stroke

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Russian Federation of Anesthesiologists and Reanimatologists	Kuban State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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