Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT03644992
Status:
UNKNOWN
Last Update Posted:
2020-10-28
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-01', 'size': 158593, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-20T11:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-25', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of different symptoms of thromboembolic disease(%)', 'timeFrame': '10 months after the operation', 'description': 'different patients will have various symptoms of embolism like dyspnea, chest pain, hemoptysis and syncope. And we plan to describe the distribution of it.'}], 'secondaryOutcomes': [{'measure': 'the location of embolism', 'timeFrame': '10 months after the operation', 'description': 'embolism can occur in different parts like the brain, limb, pulmonary and coronary systems. We plan to summarize the location of embolism.'}, {'measure': 'the risk factors of thromboembolic disease', 'timeFrame': '10 months after the operation', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thromboembolic Disease', 'Gynecological Surgery']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Volunteer to participate in the study with informed consent;\n2. Females aged 20-80 who are confirmed with some gynecological diseases and are treated with surgery but embolism happens unfortunately.\n\nExclusion Criteria:\n\n1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;\n2. Patients with blood diseases prone to thrombosis and those with a history of thrombus were excluded;\n3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);\n4. Other diseases or heavy injuries that will interfere with the results;\n5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.'}, 'identificationModule': {'nctId': 'NCT03644992', 'briefTitle': 'An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2018-07-232'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thromboembolic Disease', 'description': 'the patients who undergo gynecological operations but develop thromboembolic disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'TING LI', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Qiong ZHANG, Ph.D.', 'role': 'CONTACT', 'email': 'joan_zhang2002@sina.com', 'phone': '13587605820'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}