<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03260270</url>
  </required_header>
  <id_info>
    <org_study_id>ASU</org_study_id>
    <nct_id>NCT03260270</nct_id>
  </id_info>
  <brief_title>Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses</brief_title>
  <official_title>Detection of Asymptomatic Venous Thrombosis in Gynecological Patients With Pelvic Masses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Venous thromboembolism (VTE) is a serious preventable complication of gynecological surgery.&#xD;
      High incidence of silent VTE before surgery seems attributable to the high incidence of VTE&#xD;
      after surgery in ovarian cancer .so the aim of work is to detect silent venous thrombosis in&#xD;
      gynecological patients suffering from pelvic masses using different imaging modalities .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High incidence of silent VTE before surgery seems attributable to the high incidence of VTE&#xD;
      after surgery in ovarian cancer .&#xD;
&#xD;
      The incidence rate of DVT is about 10% to 40% in medical or general surgical patients without&#xD;
      prophylaxis .With prophylaxis, the postoperative incidence of VTE was 1.14% in women with&#xD;
      gynecological disease, and 0.7% in patients undergoing laparoscopic gynecological surgery,&#xD;
      0.3% in patients undergoing urogynecological surgery, and 4% in gynecological cancer&#xD;
      patients, respectively. Most of published studies enrolled only symptomatic patients with&#xD;
      DVT, whereas asymptomatic patients could be easily neglected under the absence of effective&#xD;
      detection. In fact, approximately 50% of DVT patients are silent, so the actual incidence of&#xD;
      postoperative DVT might be higher than reported . The asymptomatic DVT has been confirmed to&#xD;
      increase the development of post-thrombotic syndrome (PTS).&#xD;
&#xD;
      The essence of any surveillance strategy would be the identification of DVT in the&#xD;
      expectation that anticoagulation at the presymptomatic stage would prevent fatal pulmonary&#xD;
      embolism .&#xD;
&#xD;
      A number of imaging modalities are currently available to evaluate deep venous system in a&#xD;
      comprehensive manner allowing correct assessment of presence of thrombosis . Color Doppler&#xD;
      ultrasound has become the primary non invasive diagnostic method for DVT.&#xD;
&#xD;
      All patients are going to be examined by color Doppler ultrasound and by direct MDCT&#xD;
      venography .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Week</target_duration>
  <primary_outcome>
    <measure>detection of asymptomatic venous thrombosis</measure>
    <time_frame>one week before operation</time_frame>
    <description>silent venous thrombosis in gynecological patients with pelvic masses</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Silent; Thrombosis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>color doppler ultrasound</intervention_name>
    <description>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 .</description>
    <other_name>direct MDCT venography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients admitted to Assiut University hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patients in different age groups with gynecological masses detected by clinical&#xD;
             examination and different imaging modalities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with chronic kidney disease in case of contrast .&#xD;
&#xD;
          2. patients complaining from hematological diseases that may cause venous thromboembolism&#xD;
             .&#xD;
&#xD;
          3. pregnant patients .&#xD;
&#xD;
          4. patients already diagnosed with deep venous thrombosis.&#xD;
&#xD;
          5. patients not fit for surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities.</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Dr. Gehan Sayed, assit prof</last_name>
    <phone>00201224417605</phone>
    <email>gehanseifeldein@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dr.Omran Khodary, lecturer</last_name>
    <phone>00201117298484</phone>
  </overall_contact_backup>
  <reference>
    <citation>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.</citation>
    <PMID>24586595</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26426660</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17954642</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11588209</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17895896</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Kero Wagdy</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260270
org study id: ASU
nct id: NCT03260270
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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 .
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 .
observational model: Case-Only
time perspective: Prospective
measure: detection of asymptomatic venous thrombosis
time frame: one week before operation
description: silent venous thrombosis in gynecological patients with pelvic masses
intervention type: Diagnostic Test
intervention name: color doppler ultrasound
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: female patients in different age groups with gynecological masses detected by clinical examination and different imaging modalities.
minimum age: N/A
maximum age: N/A
last name: Dr. Gehan Sayed, assit prof
phone: 00201224417605
email: gehanseifeldein@yahoo.com
last name: Dr.Omran Khodary, lecturer
phone: 00201117298484
citation: 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: 24586595
citation: 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: 26426660
citation: 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: 17954642
citation: 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: 11588209
citation: 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: 17895896
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Kero Wagdy
investigator title: principal investigator
mesh term: Thrombosis
mesh term: Venous Thrombosis