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Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03260270
Enrollment
60
Registered
2017-08-24
Start date
2017-09-30
Completion date
2020-12-31
Last updated
2017-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Silent; Thrombosis

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 .

Interventions

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 .

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
detection of asymptomatic venous thrombosisone week before operationsilent venous thrombosis in gynecological patients with pelvic masses

Contacts

Primary ContactDr. Gehan Sayed, assit prof
gehanseifeldein@yahoo.com00201224417605
Backup ContactDr.Omran Khodary, lecturer
00201117298484

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026