Detection of Asymptomatic Venous Thrombosis in Gynecologi... | NCT03260270

Studies
Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

NCT03260270

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 24, 2017Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Silent; Thrombosis

Interventions

color doppler ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2017Estimated

Primary Completion Date

Sep 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Aug 22, 2017

First Submission Date that Met QC Criteria

Aug 22, 2017

First Posted Date

Aug 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2017

Last Update Posted Date

Aug 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
color doppler ultrasound	Diagnostic Test	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 .		direct MDCT venography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection of asymptomatic venous thrombosis	silent venous thrombosis in gynecological patients with pelvic masses	one week before operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

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

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients admitted to Assiut University hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr. Gehan Sayed, assit prof	Contact	00201224417605		gehanseifeldein@yahoo.com
Dr.Omran Khodary, lecturer	Contact	00201117298484

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24586595	Background	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.
26426660	Background	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.

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases