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Coronary Heart Disease Clinical Trial
Have you or your loved ones been diagnosed with coronary heart disease?
You may be eligible to participate in a coronary heart disease clinical trial.
Have you or your loved ones been diagnosed with coronary heart disease? You may be eligible to participate in a coronary heart disease clinical trial.
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Male & Female
18 Years +
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.
Details for the study
Population
Adult atients undergoing an abdominal surgery in study centers
Brief Title
The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.
Official Title
The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study
Brief Summary
Study is conducted to assess the prevalence and structure of comorbidity among patients <br /> undergoing abdominal surgery and produce the stratification of the risk of postoperative <br /> complications by identifying independent predictors for its development.
Detailed 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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
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
Secondary
mortality after abdominal surgery
30-day mortality
Study 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