NCT03260270

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

August 22, 2017

Last Update Submit

August 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • detection of asymptomatic venous thrombosis

    silent venous thrombosis in gynecological patients with pelvic masses

    one week before operation

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 .

Also known as: direct MDCT venography

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities.
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to Assiut University hospitals

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 24586595BACKGROUND
  • 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.

    PMID: 26426660BACKGROUND
  • 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.

    PMID: 17954642BACKGROUND
  • 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.

    PMID: 11588209BACKGROUND
  • 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.

    PMID: 17895896BACKGROUND

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Dr. Gehan Sayed, assit prof

CONTACT

Dr.Omran Khodary, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 24, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

August 24, 2017

Record last verified: 2017-08