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Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

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ClinicalTrials.gov Identifier: NCT03260270
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Kero Wagdy, 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 .

Condition or disease Intervention/treatment
Silent; Thrombosis Diagnostic Test: color doppler ultrasound

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 Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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 .
    Other Name: direct MDCT venography


Primary Outcome Measures :
  1. detection of asymptomatic venous thrombosis [ Time Frame: one week before operation ]
    silent venous thrombosis in gynecological patients with pelvic masses



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities.
Sampling Method:   Non-Probability Sample
Study Population
patients admitted to Assiut University hospitals
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260270


Contacts
Contact: Dr. Gehan Sayed, assit prof 00201224417605 gehanseifeldein@yahoo.com
Contact: Dr.Omran Khodary, lecturer 00201117298484

Sponsors and Collaborators
Assiut University

Publications:
Responsible Party: Kero Wagdy, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03260270     History of Changes
Other Study ID Numbers: ASU
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases