An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery
1 other identifier
observational
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 24, 2018
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 28, 2020
October 1, 2020
1 month
August 21, 2018
October 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
the location of embolism
10 months after the operation
the risk factors of thromboembolic disease
10 months after the operation
Study Arms (1)
Thromboembolic Disease
the patients who undergo gynecological operations but develop thromboembolic disease
Eligibility Criteria
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.
You may qualify if:
- Volunteer to participate in the study with informed consent;
- Females aged 20-80 who are confirmed with some gynecological diseases and are treated with surgery but embolism happens unfortunately.
You may not qualify if:
- Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
- Patients with blood diseases prone to thrombosis and those with a history of thrombus were excluded;
- History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
- Other diseases or heavy injuries that will interfere with the results;
- Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TING LI
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 24, 2018
Study Start
September 1, 2022
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
October 28, 2020
Record last verified: 2020-10