Asymptomatic Venous Thromboembolism Clinical Trial
Official title:
Incidence of Venous Thromboembolism Following Surgery in Korean Patients With Colorectal Cancer; a Prospective Study
Venous thromboembolism (VTE) has harmful effects on morbidity and mortality of cancer
patients. In Western VTE guidelines, all solid cancer patients receiving abdominal major
surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such
as low molecular weight heparin (LMWH) in the perioperative periods. These recommendations
are based on the high incidence of postoperative VTE development in Western cancer patients.
However, there have been many cumulative data about the effect of different ethnicity on the
VTE development and more and more investigators and clinicians admit that Asian ethnicity
has lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to
apply Western guidelines as it is to the clinical situation of Asian cancer patients.
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.
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | December 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically confirmed adenocarcinoma of colon or rectum - Age = 20 years - Patients receiving curative or palliative abdominal surgery (lasting = 30 minutes) (both open and laparoscopic surgery will be included) Exclusion Criteria: - No histological confirmation - 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Bundang Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The incidence of symptomatic or asymptomatic VTE | To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler US during postoperative periods in patients with CRC receiving surgery | 5~14 days after CRC surgery (by doppler venous ultrasound [US]) or the follow-up period of postoperative 1 month | No |
| Secondary | Risk factors for the development of VTE | To identify risk factors for the development of VTE in this population | 5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month | No |