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

Thromboembolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03644992
• Other study ID #: SAHoWMU-CR2018-07-232
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Qiong ZHANG, Ph.D.
• Phone: 13587605820
• Email: joan_zhang2002[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this cross-sectional study is to describe the specific situations of thromboembolic disease in gynecological surgery and identify the risk factors of it.

Description:

The electronic medical data of 54 patients who undergo operations to treat gynecological diseases but develop thromboembolic disease will be analyzed retrospectively in this study. The location, symptom and other situations of embolism will be described and multiple linear analyse will be employed to identify the risk factors of it.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gynecological Surgery
• Thromboembolic Disease
• Thromboembolism

Locations

Country	Name	City	State
China	TING LI	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of different symptoms of thromboembolic disease(%)	different patients will have various symptoms of embolism like dyspnea, chest pain, hemoptysis and syncope. And we plan to describe the distribution of it.	10 months after the operation
Secondary	the location of embolism	embolism can occur in different parts like the brain, limb, pulmonary and coronary systems. We plan to summarize the location of embolism.	10 months after the operation
Secondary	the risk factors of thromboembolic disease	Performing multiple linear regression analysis with statistical product and service solutions(SPSS) 17.0, we plan to identify the risk factors which can increase the possibility of thromboembolic disease from possible factors like hypertension, diabetes, etc.	10 months after the operation