Incidence of Venous Thromboembolism Following Surgery in Patients With Colorectal Cancer
NCT ID: NCT01567917
Last Updated: 2012-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2011-06-30
2013-12-31
Brief Summary
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Although colorectal cancer (CRC) is one of the common cancers and the incidence is rapidly increasing in Asia, there have been few prospective data on the incidence of VTE development during the postoperative period in Asian CRC patients. To our knowledge, there have been a few small-sized prospective studies in Asia and thus clear conclusions could have not been drawn based on those studies. Most Korean colorectal surgeons think that the incidence of postoperative VTE development is very rare based on their own clinical experiences. They also have much concern about the complications such as bleeding that might be caused by routine use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation, many Korean colorectal surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Asia including Korea, the uncritical acceptance of Western guidelines may be inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be answered only from our own prospective study on the incidence of postoperative VTE development after CRC surgery. Moreover, current surgical trend in cancer patients is minimally invasive approach such as laparoscopic surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not been evaluated even in Western countries. Western guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds, this study was designed.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
Patients who gave a permission to this study and underwent doppler US (Doppler US cohort
\- Expected subject no.: 400 patients
CRC surgery
Patients will receive surgery for the treatment of CRC as routine clinical practice. These patients will be prospectively observed for the development of VTE(Group A; Doppler US cohort vs. Group B; Simple observation cohort)
\- Doppler US is not an intervention. The Doppler US is a non-invasive test (ultrasonography) for the detection of VTE
Group B
Patient who gave a permission to this study, but who did not receive doppler US (Although this group of patients did not undergo doppler US, these patients will be included as group B \[simple observation cohort without doppler US examination\])
\- Expected subject no.: 200 patients
CRC surgery
Patients will receive surgery for the treatment of CRC as routine clinical practice. These patients will be prospectively observed for the development of VTE(Group A; Doppler US cohort vs. Group B; Simple observation cohort)
\- Doppler US is not an intervention. The Doppler US is a non-invasive test (ultrasonography) for the detection of VTE
Interventions
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CRC surgery
Patients will receive surgery for the treatment of CRC as routine clinical practice. These patients will be prospectively observed for the development of VTE(Group A; Doppler US cohort vs. Group B; Simple observation cohort)
\- Doppler US is not an intervention. The Doppler US is a non-invasive test (ultrasonography) for the detection of VTE
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 20 years
* Patients receiving curative or palliative abdominal surgery (lasting ≥ 30 minutes) (both open and laparoscopic surgery will be included)
Exclusion Criteria
* Patients who already have VTE (or pulmonary embolism) at the screening periods of this study
* Past medical history of VTE or pulmonary embolism
* Patients with the history of other cancer (Patients who were disease-free for \> 5 years from previous other cancer is allowed to be included in this study)
* Patients with thrombophilia or other comorbidities requiring anticoagulation (i.e. atrial fibrillation or cerebral infarct requiring anticoagulation
20 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Keun-Wook Lee
Principal investigator
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Keun-Wook Lee, M.D.. & Ph.D.
Role: primary
Other Identifiers
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CRC-SNUBH-2012-01
Identifier Type: -
Identifier Source: org_study_id