Nghiên cứu thuyên tắc huyết khối tĩnh mạch và các yếu tố nguy cơ trên bệnh nhân phẫu thuật phụ khoa ttta

MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEALTH HANOI MEDICAL UNIVERSITY NGUYEN THI THU PHUONG VENOUS THROMBOEMBOLISM AND RISK FACTORS IN GYNECOLOGICAL SURGERY PATIENTS SUMMARY OF THESIS DOCTOR OF MEDICINE HANOI - 2023 THE THESIS IS COMPLETED AT HANOI MEDICAL UNIVERSITY Scientific mentor: Ass.Prof PhD Pham Ba Nha Ass.Prof.PhD Dinh Thi Thu Huong Reviewer 1: Prof PhD Cao Ngoc Thanh Reviewer 2: Prof PhD Nguyen Duy Anh Reviewer 3: Ass Prof PhD Nguyen Thi Bach Yen The thesis will be presented by the Board of thesis dissertation Meeting at Ha Noi Medical University At by the day of the: The thesis can be found in the libraries: - National Library of Vietnam - Library of Hanoi Medical University INTRODUCTION Venous thromboembolism (VTE) is a disorder of venous circulation due to the presence of thrombosis including deep vein thrombosis (DVT) and pulmonary embolism (PE) VTE is one of the common medical problems in many specialties include gynecological patients with exclusive high mortality, morbidity and medical costs, but it is often overlooked and unnoticed until important events after the surgery occurred The disease is not uncommon in many countries and in Vietnam with the number of new cases and the incidence is not small, in which the risk of un-preventive hospitalized patients ranges from 10-80% This is considered a silent killer as nearly 80% of cases were asymptomatic and over 70% of deaths due to PE were identified only after autopsies according to research by Stein Paul D et al in the US According to research by Clarke - Pearson, about 40% of deaths from PE were occurred after gynecological surgery; two-thirds patients died within the first 30 minutes of PE, VTE might be missed and blamed on surgical intervention, posing a difficult challenge for clinicians In the world and in Vietnam, many studies on VTE related to risk factors, diagnosis, treatment and prevention have been performed, but mainly on surgical patients - orthopedic trauma, internal medicine, resuscitation, cardiology In Vietnam, although the prevalence of gynecological diseases and surgery is increasing day by day, few studies on VTE on gynecological patients, especially surgical patients have been conducted, almost no information was published The status of VTE is still not fully understood, the symptoms of the disease are not always clear, the risk factors of the group of gynecological surgery patients are not evaluated systematically, the gynecological clinicians have not yet having a lot of experience and paying enough attention to the disease, so data on the actual status of the disease was not published, so official guideline process and management protocol in diagnosis, treatment and prevention of the specialty has not been completely developed….VTE with the short-term complications of sudden death due to PE and the long-term complications of postthrombotic syndrome that can affect the quality of life, activities and work of patients undergoing gynecological surgery is gradually posed more care and attention With the desire to have more scientific evidence to better understand the status and risk factors of this pathology, we conducted the study “Venous thromboembolism and risk factors in gynecological surgery patients” with the objectives: Determining the prevalence, clinical and paraclinical characteristics of venous thromboembolism in gynecological surgery patients Evaluating several risk factors for venous thromboembolism in gynecological surgery patients NEW CONTRIBUTIONS OF THE THESIS The study has determined the prevalence of venous thromboembolism, clinical and laboratory characteristics in gynecological surgery patients with thrombosis Given some risk factors of VT in gynecological surgery patients such as Age over 45 years, heavy physical labor of work; being suffered from uterine fibroids, ovarian cancer, malignant diseases; experiencing uterine related surgery; several acquired risk factors; acquired diseases (chronic heart failure, history of trauma of spine, spinal cord, lower extremities, hypertension, diabetes), huge blood loss in surgery would increase the risk of venous thromboembolism STRUCTURE OF THE THESIS In addition to parts Introduction and Conclusion, the thesis includes chapters: Chapter 1: Literature review 41 pages; Chapter 2: Subjects and research methods 20 pages; Chapter 3: Research results 30 pages; Chapter 4: Discussion 44 pages The thesis has 12 figures, 57 tables, charts, diagrams, 148 references (18 Vietnamese, 130 English) CHAPTER 1- LITERATURE REVIEW 1.1 Diagnosis of venous thromboembolism 1.1.1 Diagnosis of deep vein thrombosis (DVT) Definitive diagnosis: based on clinical and paraclinical symptoms and assessment of risk factors: - Clinical symptoms: swelling, pain, purpleness, leg numbness, increased calf-thigh circumference, Homans sign; Posterior leg muscle mass compression test (+); some chronic symptoms; Assessment of risk factors to promote DVT and evaluate the risk of DVT in clinical practice, based on that to indicate D-dimers test (for patients with low clinical probability to exclude diagnosis of DVT) or venous ultrasound (for patients with intermediate or high clinical probability to confirm the diagnosis of DVT) - Subclinical symptoms: + D-Dimer test: Negative result (D-Dimer < 500 µg/L) has a value to exclude DVT Patients with low risk of DVT clinically are recommended to have a D-Dimer test first A negative result helps to rule out DVT without further testing + Intravenous Doppler ultrasound with pressure test (or with pressure): It is a simple method, with high sensitivity and specificity, especially for proximal venous thrombosis (above the knee) Doppler ultrasound is recommended in patients with a high or moderate clinical probability of developing DVT Diagnosis is confirmed when a thrombus is observed filling the venous lumen, causing the vein to not collapse, or only partially Positive ultrasound results allow the diagnosis of DVT A negative result requires additional D-dimer test, and a repeat ultrasound may be required within a week + Contrast venography: Although it is the "Gold standard" for diagnosing DVT, it has been replaced by venous ultrasound with pressure test Contrast venography is considered indicated in patients at high clinical risk for DVT, but noninvasive tests have been inconsistent, or not available Differential diagnosis With some diseases with similar clinical signs of DVT However, venous ultrasound with compression, by an experienced physician, can help in the differential diagnosis of these conditions: Cellulitis; Superficial VTE of the lower extremities; Baker's cocoon; Intramuscular hematoma 1.1.2 Diagnosis of acute pulmonary embolism (PE) Definitive diagnosis: based on clinical, laboratory and risk factors assessment - Clinical symptoms: dyspnea when resting or exertion, appeared often suddenly; crackles or wet rales, feeling of chest tightness, hemoptysis, pleuritic chest pain; tachypnea, tachycardia, strong pulmonary S2, pulmonary rales, decreased vibration, neck veins distention; swelling, pain, redness of lower limb if accompanied by the DVT Finding signs showing severity (in order to decide on the diagnosis process, emergency treatment of PE): shock, prolonged hypotension - Subclinical symptoms: + D-Dimer test + Some diagnostic imaging methods: # Multi-slice computed tomography (MDCT) pulmonary artery: # Lung ventilation/perfusion scintigraphy: # Contrast Pulmonary Angiography: Although it is the "gold standard" to diagnose or rule out pulmonary embolism, it is currently very rarely indicated because it is replaced by a pulmonary artery MDCT For patients with suspected pulmonary embolism who are hemodynamically stable, contrast-enhanced pulmonary angiography may be considered if there is no agreement between the clinical assessment and the noninvasive imaging studies # Venous Doppler ultrasound with pressure manoeuvres # Doppler echocardiography: Diagnosis of right ventricular dysfunction and increased right ventricular pressure burden in acute pulmonary embolism Differential diagnosis For other causes of shock, hypotension, or chest pain, dyspnea: Acute myocardial infarction, Lobar pneumonia, Acute left heart failure, Primary pulmonary hypertension, Bronchial asthma attacks, Pericarditis, Pneumothorax, Broken rib, Costochondritis, Myalgia, intercostal neuralgia Diagnosis of severity: Based on hemodynamic status and clinical and laboratory parameters, risk stratification Assessing the risk of clinical pulmonary artery obstruction: Using forecasting scale such as Wells, Improved Geneva is an important starting step to assess the risk of clinical pulmonary artery blockage 1.2 Gynecological surgery The female reproductive system is located deep in the pelvis, including: ovaries, fallopian tubes, uterus, vagina, vulva, not to mention dependent glands and mammary glands Gynecological diseases that require surgery include benign and malignant diseases of the genital organs such as: Fibroids - cysts - endometriosis - cancer in the uterus, fallopian tubes, and ovaries, vagina, vulva; genital prolapse, molar pregnancy, trophoblastoma, suspected lesions and cervical cancer, cervical and uterine polyps Gynecological surgery is classified according to the surgical route, including abdominal surgery, vaginal surgery, and laparoscopy; according to surgical organs including surgery on the ovaries, fallopian tubes, broad ligament, uterus, cervix, surgery on rectal prolapse and urinary incontinence (urinary tract), surgery on the vagina-vulva- perineal; according to the degree of surgery minor surgery, intermediate surgery and major surgery 1.3 Venous thromboembolism with Gynecological surgery Venous thromboembolism (VTE) is the general term for two clinical forms of the same disease: Deep vein thrombosis, mainly lower limb deep vein thrombosis (DVT) and Pulmonary embolism (PE) Studies in the world have shown that for gynecological surgery, PE is the leading cause of postoperative mortality, especially for gynecological cancer; Cases of MS that can develop into PE lead to a mortality rate of about 10% From the statistics on these fatal complications, VTE has received high interest in gynecological surgery Liu et al reported 22 cases of DVT in total 141 cases experienced gynecological surgery (15.6%) In addition, the incidence of DVT is relatively higher in patients with gynecological tumors; The perioperative risk of DVT has been reported to range from 19.6 to 38% in gynecological cancers compared with 10 to 15% in benign tumors A retrospective study by a group of Chinese authors in 2015 showed that among 498 patients, 58 patients had thrombosis, the prevalence of VTE was 11.6%; Of these, cases developed into PE and patients died, the mortality rate for PE was 33.3% The ACCP 2008 recommendations indicate that the absolute risk of DVT in inpatients without thromboprophylaxis in the group of patients undergoing major gynecological surgery is very high, ranging from 15 to 40% There are many independent risk factors, of which immobility is one of the major risk factors for the development of VTE - a nearly 9- fold increase in bed-ridden patients In addition, time of hospital stay and surgery also increased the risk of thrombosis (11.9 and 5.9 times, respectively) In Vietnam, in recent years, the pathology of VTE has been receiving widespread and intense attention from medical scientists, but there have not been many studies in the field of Obstetrics and Gynecology, mainly on other specialties as internal medicine, resuscitation, surgery trauma The initial study on the rate of deep vein thrombosis of the lower extremities (DVT) in pregnant women after cesarean section at Bach Mai hospital, published in 2012 by Luu Tuyet Minh, was 13.5% Another study of the same author on 846 women after cesarean section at Bach Mai hospital and at other hospitals who transferred to Bach Mai hospital for post-operative treatment gave the following results: the percentage of surgery group Pregnancy at Bach Mai hospital was 0.98% (4/407 women) and 15.26% (67/439 women) in the group transferred to Bach Mai hospital for post-surgery treatment Statistically significant associations with the factors of this study include: Labor lasting more than 24 hours, pathological pregnancy; infection status (+) prolonged immobilization and hospital stay for more than days are: OR19.9 (95%CI: 5.35 - 73.97); (OR 47.2; 95%CI: 1.12 - 1994) CHAPTER 2- RESEARCH SUBJECTS AND METHODS 2.1 Research object Objective - Determine the prevalence, clinical and subclinical characteristics of venous thromboembolism in gynecological surgery patients Patients undergoing gynecological surgery were diagnosed with thrombosis when the results of deep vein Doppler ultrasound of the lower extremities after gynecological surgery showed thrombosis Patients with thrombosis or receiving measures to prevent deep vein thrombosis or patients receiving unfractionated heparin or lowmolecular-weight heparin for medical treatment of non-DVT, Warfarin in 48 hours before surgery were not included in the study Objective - To study some risk factors for venous thromboembolism in gynecological surgery patients Gynecological surgery patients who met the inclusion criteria and agreed to participate in the study were divided into groups with lower extremity deep vein thrombosis and no, and then conducted comparative tests between the two groups Group to determine factors related to the incidence of DVT 2.2 Research Methods 2.2.1 Research design a Objective 1- Determine the prevalence, clinical and paraclinical characteristics of venous thromboembolism in gynecological surgery patients : A prospective descriptive study with analysis on patients before and after minor surgery department Apply the sample size estimation formula for a research population to calculate the minimum sample size for the study : p (1 - p) n = Z2(1-/2) (p.Ɛ)2 In which: n: Minimum study sample size; Z (1-α/2): Reliability coefficient, with statistical significance = 0.05; corresponding to the 95% confidence level, then Z (1-α/2) = 1.96; p: The estimated rate of VTE in gynecological surgery patients is 11.6% [According to Lihua Zhang (2015) in China]; Ɛ: Relative error (Ɛ = 0.24) Substitute the above formula for n = 508 patients Use non-probability convenience sampling method Take all patients indicated for Gynecological surgery who meet the selection criteria until the sample size is sufficient In fact, the study collected 532 patients who were eligible to participate in the study b Objective - To study some risk factors for venous thromboembolism in gynecological surgery patients All gynecological surgery patients included in the study according to objective will be interviewed by questionnaire about genetic factors, habits, medical history, then, using chi square test or Fisher' exact to test the difference between incidence rates and no incidence according to independent factors, put into univariate and multivariate regression models to determine related factors to DVT 2.2.2 Research process: The study will conduct a maximum of times of Doppler ultrasound, including: Patients with indications for Gynecological surgery should undergo Comprehensive clinical examination, risk stratification of VTE risk 1st time Doppler ultrasound of blood vessels in the lower extremities (before surgery) In case 1, no DVT/VTE is detected, the patient will be invited to participate in the study, then proceed to gynecological surgery Second time Doppler ultrasound of the lower extremities (3-7 days after surgery), the second time The third Doppler ultrasound will be conducted when the 2nd time had not detected thrombus and will be done in the 2nd to 4th week after gynecological surgery, during the Doppler ultrasound, if found to have DVT/VTE will be transferred to a specialist cardiology consultation for treatment coordination 2.2.3 Doppler ultrasound technique: Detecting venous thrombosis by Doppler ultrasound technique includes: Using an ultrasound probe that gently compresses the vein, surveying the flow on color Doppler on 2D ultrasound Sometimes using the “two-handed technique”, using the free hand to push the thigh against the transducer produces appropriate pressure Cross-sectional compression of the vein was examined using the transducer gently compressing the vessel at a distance of about cm, while observing changes in the diameter of the vessel on the ultrasound screen Conduct Doppler ultrasound to probe the vena cava - pelvis, femoral - popliteal veins, deep veins in the legs The ultrasound results are determined as follows: Complete thrombosis causes complete occlusion of the venous lumen: - Live images: Enlarged veins right in the lying position, round veins (cross section); Non-collapsed pressed vein under the transducer; On 2D ultrasound can clearly see the morphology of the thrombus, the thrombus usually adheres firmly to the vein wall, so the same thrombosed vein will not dilate during the Valsalva maneuver; On pulsed Doppler and color Doppler ultrasound: Absolutely no signal is recorded in the venous lumen - Indirect image: Decrease the velocity of circulation above the site of the vein occlusion; Increases circulation in the branches of the veins by the system (Saphenous veins in the lower extremities) Incomplete thrombus that partially fills the venous lumen - Incomplete compression of the vein, Valsalva maneuver or muscle contraction below the transducer site can cause varicose veins - On 2D ultrasound: Observe that the thrombus does not completely adhere to the vein wall Note the case where the venous lumen is not clear but dense with coiled sound and dark clouds When to test the "venous ejection" by squeezing muscles downstream of the vein examine: observe in longitudinal view if the vein wall and/or around the foot of the venous valve still have deep echoes and convex into the lumen vein, it was assessed as a new thrombus formed at the site of the exploratory vein - On color Doppler ultrasound, a part of the flow in the vein with thrombus is still recorded * New diagnostic criteria for thrombosis: - Brighter echo density, homophone The vein is not dilated if the thrombus is very fresh - There has been no phenomenon of recanalization of the flow between the thrombus and collateral circulation: Can be determined by color Doppler, pulse Doppler Very new case of thrombosis: Movable thrombus head (Very dangerous, possibly thrombus shooting into the pulmonary artery causing pulmonary embolism) A follow-up study of timed ultrasound scans before or within 24 hours after surgery and 3-7 days to weeks after surgery in all sites of the lower extremity deep vein system to detect thrombosis newly formed, developing new thrombus within the first weeks after surgery 2.3 Time and location of study -Research location: Department of Obstetrics and Gynecology, Bach Mai Hospital -Research period: From January 1, 2018 to July 7, 2020 11 3.2 Some risk factors for venous thromboembolism in gynecological surgery patients found in the study group Table 3.1 Multivariable regression model of the association between demographic characteristics and deep vein thrombosis Characteristic Age group Under 45 45 - 60 61 - 74 Above 75 Professional nature Light labor Heavy labor Multivariable logistic model aOR 95%CI p 7.95 21.46 8.84 2.09 – 30.29 4.89 – 94.13 0.76 – 103.59