Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

• Conditions: Silent; Thrombosis

• Registration Number: NCT03260270
• Lead Sponsor: Assiut University

Brief Summary

Venous thromboembolism (VTE) is a serious preventable complication of gynecological surgery. High incidence of silent VTE before surgery seems attributable to the high incidence of VTE after surgery in ovarian cancer .so the aim of work is to detect silent venous thrombosis in gynecological patients suffering from pelvic masses using different imaging modalities .

Detailed Description

High incidence of silent VTE before surgery seems attributable to the high incidence of VTE after surgery in ovarian cancer .

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 .

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Study First Posted: 2017-08-24
• Last Update Posted: 2017-08-24
• Study Start: 2017-09
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• female patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities.

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Exclusion Criteria

1. patients with chronic kidney disease in case of contrast .
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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection of asymptomatic venous thrombosis	one week before operation	silent venous thrombosis in gynecological patients with pelvic masses