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临床试验/NCT03260270
NCT03260270Unknown不适用

Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

Assiut University0 个研究点目标入组 60 人开始时间: 2017年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
detection of asymptomatic venous thrombosis

研究概览

简要总结

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 .

详细描述

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 .

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • patients with chronic kidney disease in case of contrast .
  • patients complaining from hematological diseases that may cause venous thromboembolism .
  • pregnant patients .
  • patients already diagnosed with deep venous thrombosis.
  • patients not fit for surgery.

结局指标

主要结局

detection of asymptomatic venous thrombosis

时间窗: one week before operation

silent venous thrombosis in gynecological patients with pelvic masses

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kero Wagdy

principal investigator

Assiut University

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