An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery
Conditions: Thromboembolic Disease, Gynecological Surgery
Sponsor: Second Affiliated Hospital of Wenzhou Medical University

 
 
 
 
 
 
 
 
 
 
 
 
 
An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in 
Gynecological Surgery 
 
2018.06.01 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

Study objectives The primary objective of this part is to describe the situations of thromboembolic 
disease in gynecological surgery like the different symptoms and locations of embolism. The 
secondary objective of this study is to identify the risk factors of thromboembolic disease using 
multiple linear regression analysis. 
Trial design This is an retrospective cross-sectional observatory trial. After signing of informed 
consent, the electronic medical data of patients undergoing gynecological surgery but developing 
embolism unfortunately will be analyzed retrospectively in this study. The symptoms of embolism 
like dyspnea, chest pain, hemoptysis and syncope during the procedure is spoken by patines and 
recorded by her doctor in charge. They are also responsible for writing down the location of 
embolism. All patients have complete blood counts before the operation and on the second or the 
third post-operative day. The risk factors of it can be identified using the multiple linear regression 
analysis. An overview of the study design is shown in Figure 1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect clinical data of patients (include: age, gender, 
body mass index, diagnosis, ASA classification, surgical 
time, surgical bleeding, blood transfusion volume, 
preoperative value of Hct, preoperative value of Hb, the 
amount of drainage) 
Describe the specific situations of embolism 
Apply multiple linear regression analysis to identify the 
risk factors of thromboembolic disease 

Sample size The planned sample size was based on data from a previous study, in which the standard 
deviation was 5. We assumed an one-tailed α error of 0.05 and a sampling error of 1.0. we propose 
to enroll 60 participants and allow for a dropout rate of 10% for an effective sample size of 54.  
Inclusion criteria 
1. 
Volunteer to participate in the study with informed consent; 
2. 
Females aged 20-80 who are confirmed with some gynecological diseases and are treated with 
surgery but embolism happens unfortunately. 
Exclusion criteria 
1. 
Pregnancy, lactation, postmenopause, or planned pregnancy within two years; 
2. 
Patients with blood diseases prone to thrombosis and those with a history of thrombus were 
excluded; 
3. 
History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune 
diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 
4. 
Other diseases or heavy injuries that will interfere with the results; 
5. 
Simultaneous participation in another clinical study with investigational medicinal product(s) 
or researcher thinks the subjects are not suitable for this trial. 
 
Outcomes measures 
The primary outcome is the percentage of different symptoms of thromboembolic disease(%) The 
secondary outcomes are the location of embolism according to the results of multiple linear 
regression analysis.  
Withdrawal Subjects must be withdrawn from the study when one of the following criteria occurs: 
1. At their own request. At any time during the study and without giving reasons, a subject may 
decline to participate further. The subject will not suffer any disadvantages as a result; 
2. In the investigator's opinion, continuation of the study treatment would be harmful to the subject's 
health; 
3. Obvious non-compliance; 
4. Lost to follow-up; 
5. Pregnancy; 
Safety assessments Safety will be assessed by renal and liver function test, electrolyte, routine 
blood test. Other indicators are detected during the operation and rehabilitation period. The 
occurrence of any adverse events in participants will be recorded in the case report forms during 
each patient visit. We will withdraw patients who have severe adverse events, as it is unsafe for 
them to continue the trial. Meanwhile, we will give them relevant medical care and follow them up 
until the reaction has terminated. 
Statistical analysis 
Multiple linear regression analysis was applied to evaluate the risk factors of embolism related to 
14 independent variables including four qualitative variables(hypertension, diabetes mellitus, 
diagnosis according to the FIGO staging system and the pathological tumor type) and eight 
quantitative variables (age, BMI, the numbr of lymph nodes, the interval between biopsy and 
operation, surgical time, surgical bleeding, postoperative anticoagulant time, preoperative value of 
Hb, preoperative value of RBC and preoperative value of Hct). All statistical analyses were 
performed by SPSS 17.0 software package and the level of statistical significance was set at P<0.05. 
All independent variables were incorporated into the model using the method of “Enter”. Data are 

presented as mean ± standard deviation.