Silent; ThrombosisNCT03260270
Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses
An observational study of Silent; Thrombosis, run by Assiut University.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Silent; Thrombosis
- What is being tested?
- color doppler ultrasound
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Dec 2020
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Study population: patients admitted to Assiut University hospitals
Who may be able to join
- female patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Dr.Omran Khodary, lecturer contact
About this study
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 .
- Conditions
- Silent; Thrombosis
- Being tested
- color doppler ultrasound
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color doppler ultrasoundDiagnostic test
Also called direct MDCT venography
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of asymptomatic venous thrombosis
silent venous thrombosis in gynecological patients with pelvic masses
Measured: one week before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Silent; ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kero Wagdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260270
- Sponsor's protocol ID
- ASU
- Status last verified
- Aug 2017
- First submitted
- 22 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 24586595Qu 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 26426660Goodman 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 17954642Kelly 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 11588209Satoh 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses
- ClinicalTrials.gov ID
- NCT03260270
- Acronym / sponsor ID
- ASU
- Conditions
- Silent; Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted to Assiut University hospitals
Key inclusion criteria (1 listed)
- female patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| color doppler ultrasoundAlso: direct MDCT venographyAll patients are going to be examined by color Doppler ultrasound and the high risk patients are going to be examined by direct MDCT venography . | Diagnostic test | – |
Primary outcome
detection of asymptomatic venous thrombosis
Time frame: one week before operation
silent venous thrombosis in gynecological patients with pelvic masses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Background: PubMed 24586595Ikeda 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.
- Background: PubMed 26426660Qu 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.
- Background: PubMed 17954642Goodman 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.
- Background: PubMed 11588209Kelly 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.
- Background: PubMed 17895896Satoh 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Omran Khodary, lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Silent; Thrombosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Gehan Sayed, assit prof (00201224417605, gehanseifeldein@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of asymptomatic venous thrombosis (time frame: one week before operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260270, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.