ClinicalTrials.gg
Status unknownNCT03260270Updated Aug 24, 2017

Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses

An observational study in Silent; Thrombosis, sponsored by Assiut University. Status unknown. Open to female participants. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Sex
Female
01

Study 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 .

Read the 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 .

02

Conditions studied

  • Silent; Thrombosis

Browse trials for

03

In context

Thrombosis

1,528 studies on the registry are indexed under Thrombosis; 240 are open to participants now.

This study's planned enrollment of 60 is below the median of 212 across 591 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

patients admitted to Assiut University hospitals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Interventions

  • Diagnostic testcolor 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 .

    Also known as: direct MDCT venography

06

What researchers measure

Primary outcomes

  1. detection of asymptomatic venous thrombosis

    silent venous thrombosis in gynecological patients with pelvic masses

    Time frame: one week before operation

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24586595 ↗
  • 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. PubMed 26426660 ↗
  • 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. PubMed 17954642 ↗
  • 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. PubMed 11588209 ↗
  • 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. PubMed 17895896 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2017; primary completion for Sep 2020, 36 months later.

Of 243 non-industry observational studies under Thrombosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 107. This study's planned 36 months is below that.

Counting every sponsor, half of 267 studies reached it within 42 months; a quarter within 19 and three quarters within 99.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2017
First posted
Aug 24, 2017
StartEst.
Sep 2017
Primary completionEst.
Sep 2020
CompletionEst.
Dec 2020
Last update
Aug 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03260270
Lead sponsor
Assiut University
Responsible party
Kero Wagdy (principal investigator, Assiut University) — Principal investigator
First posted
Aug 24, 2017
Start date
Sep 2017 (estimated)
Primary completion
Sep 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Aug 24, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion