Unique ID issued by UMIN | UMIN000017475 |
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Receipt number | R000020252 |
Scientific Title | Incidence of Venous Thromboembolism Following Laparoscopic Surgery for Gastrointestinal Cancer: A Single-Center, Prospective Cohort Study |
Date of disclosure of the study information | 2015/05/09 |
Last modified on | 2015/05/09 07:52:00 |
Incidence of Venous Thromboembolism Following Laparoscopic Surgery for Gastrointestinal Cancer: A Single-Center, Prospective Cohort Study
Incidence of Venous Thromboembolism Following Laparoscopic Surgery
Incidence of Venous Thromboembolism Following Laparoscopic Surgery for Gastrointestinal Cancer: A Single-Center, Prospective Cohort Study
Incidence of Venous Thromboembolism Following Laparoscopic Surgery
Japan |
Gastric cancer, colorectal cancer
Surgery in general |
Malignancy
NO
The purpose of this study was to investigate the safety of using Fondaparinux sodium and intermittent pneumatic compressionand for laparoscopic surgery identify the associated risk factors.
Safety
Others
Others
Not applicable
Safety assessment of Fondaparinux sodium and intermittent pneumatic compression for laparoscopic surgery
1) Identify the incidence of VTE in Japanese patients undergoing laparoscopic surgery
2) Identify the risk factors for VTE
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Fondaparinux sodium
40 | years-old | <= |
Not applicable |
Male and Female
1) Forty years or over 40 years old.
The patient
2) Planned elective laparoscopic surgery for gastric and colorectal malignancy
1) Treatment with anticoagulants, dextran, thrombolytics, or antiplatelet agents within the past week.
2) Active bleeding
3) Thrombocytopenia
4) Disorders associated with an increased risk of bleeding, such as gastrointestinal tract ulcers, diverticulitis, colitis, acute bacterial endocarditis, severe uncontrolled hypertension, or severe uncontrolled diabetes mellitus
5) Severe hepatic dysfunction (Child class C)
6) A known history of hypersensitivity to unfractionated heparins, low-molecular-weight heparins, or heparinoids; a history of intracranial bleeding
7) A history of surgical intervention of the central nervous system or ocular surgery within the past 3 months; severe renal dysfunction, defined as a creatinine clearance of <20 ml/min; a history of major orthopedic, abdominal, or cardiovascular surgery within the past 3 months; clinical signs of VTE
8) A history of arterial thromboembolism
9) Drug abuse or alcohol dependence
10) Another elective surgical intervention during the study period
11) Pregnancy or lactation; and deemed by the attending physician as unfit for the study.
100
1st name | |
Middle name | |
Last name | Eiji Oki |
Kyushu University
Department of Surgery and Science,
Maidashi 3-1-1, Higashi-ku, Fukuoka
092-642-5466
okieiji@surg2.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Eiji Oki |
Kyushu University
Department of Surgery and Science,
Maidashi 3-1-1, Higashi-ku, Fukuoka
092-642-5466
okieiji@surg2.med.kyushu-u.ac.jp
Graduate School of Kyushu University
none
Other
NO
2015 | Year | 05 | Month | 09 | Day |
Unpublished
Terminated
2012 | Year | 05 | Month | 31 | Day |
2012 | Year | 05 | Month | 12 | Day |
2015 | Year | 05 | Month | 09 | Day |
2015 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020252
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