Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses
NCT ID: NCT03260270
Last Updated: 2017-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2017-09-30
2020-12-31
Brief Summary
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Detailed Description
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The incidence rate of DVT is about 10% to 40% in medical or general surgical patients without prophylaxis .With prophylaxis, the postoperative incidence of VTE was 1.14% in women with gynecological disease, and 0.7% in patients undergoing laparoscopic gynecological surgery, 0.3% in patients undergoing urogynecological surgery, and 4% in gynecological cancer patients, respectively. Most of published studies enrolled only symptomatic patients with DVT, whereas asymptomatic patients could be easily neglected under the absence of effective detection. In fact, approximately 50% of DVT patients are silent, so the actual incidence of postoperative DVT might be higher than reported . The asymptomatic DVT has been confirmed to increase the development of post-thrombotic syndrome (PTS).
The essence of any surveillance strategy would be the identification of DVT in the expectation that anticoagulation at the presymptomatic stage would prevent fatal pulmonary embolism .
A number of imaging modalities are currently available to evaluate deep venous system in a comprehensive manner allowing correct assessment of presence of thrombosis . Color Doppler ultrasound has become the primary non invasive diagnostic method for DVT.
All patients are going to be examined by color Doppler ultrasound and by direct MDCT venography .
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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color doppler ultrasound
All patients are going to be examined by color Doppler ultrasound and the high risk patients are going to be examined by direct MDCT venography .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. patients complaining from hematological diseases that may cause venous thromboembolism .
3. pregnant patients .
4. patients already diagnosed with deep venous thrombosis.
5. patients not fit for surgery.
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Kero Wagdy
principal investigator
Central Contacts
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Dr.Omran Khodary, lecturer
Role: CONTACT
References
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Ikeda M, Kan-no H, Hayashi M, Tsukada H, Shida M, Hirasawa T, Muramatsu T, Ogushi Y, Mikami M. Predicting perioperative venous thromboembolism in Japanese gynecological patients. PLoS One. 2014 Feb 26;9(2):e89206. doi: 10.1371/journal.pone.0089206. eCollection 2014.
Qu H, Li Z, Zhai Z, Liu C, Wang S, Guo S, Zhang Z. Predicting of Venous Thromboembolism for Patients Undergoing Gynecological Surgery. Medicine (Baltimore). 2015 Sep;94(39):e1653. doi: 10.1097/MD.0000000000001653.
Goodman LR, Stein PD, Matta F, Sostman HD, Wakefield TW, Woodard PK, Hull R, Yankelevitz DF, Beemath A. CT venography and compression sonography are diagnostically equivalent: data from PIOPED II. AJR Am J Roentgenol. 2007 Nov;189(5):1071-6. doi: 10.2214/AJR.07.2388.
Kelly J, Rudd A, Lewis RR, Hunt BJ. Screening for subclinical deep-vein thrombosis. QJM. 2001 Oct;94(10):511-9. doi: 10.1093/qjmed/94.10.511. No abstract available.
Satoh T, Oki A, Uno K, Sakurai M, Ochi H, Okada S, Minami R, Matsumoto K, Tanaka YO, Tsunoda H, Homma S, Yoshikawa H. High incidence of silent venous thromboembolism before treatment in ovarian cancer. Br J Cancer. 2007 Oct 22;97(8):1053-7. doi: 10.1038/sj.bjc.6603989. Epub 2007 Sep 25.
Other Identifiers
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ASU
Identifier Type: -
Identifier Source: org_study_id
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