Thromboembolic DiseaseNCT03644992
An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery
An observational study of Thromboembolic Disease and Gynecological Surgery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Thromboembolic Disease, Gynecological Surgery
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Thromboembolic Disease, Gynecological Surgery
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thromboembolic Disease | the patients who undergo gynecological operations but develop thromboembolic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months after the operation
Secondary outcomes (2)
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.
Measured: 10 months after the operation
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.
Measured: 10 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644992
- Sponsor's protocol ID
- SAHoWMU-CR2018-07-232
- Status last verified
- Oct 2020
- First submitted
- 21 Aug 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03644992
- Acronym / sponsor ID
- SAHoWMU-CR2018-07-232
- Conditions
- Thromboembolic Disease, Gynecological Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thromboembolic Disease | – | –the patients who undergo gynecological operations but develop thromboembolic disease |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the percentage of different symptoms of thromboembolic disease(%)
Time frame: 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.
2 secondary outcomes
the location of embolism
Time frame: 10 months after the operation
the risk factors of thromboembolic disease
Time frame: 10 months after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolic Disease and Gynecological Surgery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiong ZHANG, Ph.D. (13587605820, joan_zhang2002@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of different symptoms of thromboembolic disease(%) (time frame: 10 months after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.