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

• Conditions: Thromboembolic Disease; Gynecological Surgery

• Registration Number: NCT03644992
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-24
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-28
• Study Start: 2022-09-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the percentage of different symptoms of thromboembolic disease(%)	10 months after the operation	different patients will have various symptoms of embolism like dyspnea, chest pain, hemoptysis and syncope. And we plan to describe the distribution of it.

Secondary Outcome Measures

Name	Time	Method
the location of embolism	10 months after the operation	embolism can occur in different parts like the brain, limb, pulmonary and coronary systems. We plan to summarize the location of embolism.
the risk factors of thromboembolic disease	10 months after the operation	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.

Trial Locations

Locations (1)

TING LI; 🇨🇳 Wenzhou, Zhejiang, China