Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

NCT ID: NCT03260270

Last Updated: 2017-08-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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 .

Conditions

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Silent; Thrombosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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 .

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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direct MDCT venography

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Kero Wagdy

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Dr. Gehan Sayed, assit prof

Role: CONTACT

00201224417605

Dr.Omran Khodary, lecturer

Role: CONTACT

00201117298484

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.

Reference Type BACKGROUND
PMID: 24586595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26426660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17954642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11588209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17895896 (View on PubMed)

Other Identifiers

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ASU

Identifier Type: -

Identifier Source: org_study_id

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