Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

Silent; Thrombosis Clinical Trial

Official title:

Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03260270
• Other study ID #: ASU
• Status: Not yet recruiting
• Phase: N/A
• First received: August 22, 2017
• Last updated: August 22, 2017
• Start date: September 2017
• Est. completion date: December 2020

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Dr. Gehan Sayed, assit prof
• Phone: 00201224417605
• Email: gehanseifeldein[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Silent; Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Diagnostic Test:
• 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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View Citation

Kelly J, Rudd A, Lewis RR, Hunt BJ. Screening for subclinical deep-vein thrombosis. QJM. 2001 Oct;94(10):511-9. Review. — View Citation

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. — View Citation

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. Epub 2007 Sep 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of asymptomatic venous thrombosis	silent venous thrombosis in gynecological patients with pelvic masses	one week before operation