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Clinical Trials/NCT01567917
NCT01567917
Unknown
Not Applicable

Incidence of Venous Thromboembolism Following Surgery in Korean Patients With Colorectal Cancer; a Prospective Study

Seoul National University Bundang Hospital1 site in 1 country600 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Symptomatic Venous Thromboembolism
Sponsor
Seoul National University Bundang Hospital
Enrollment
600
Locations
1
Primary Endpoint
The incidence of symptomatic or asymptomatic VTE
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
December 2013
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Keun-Wook Lee

Principal investigator

Seoul National University Bundang Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

The incidence of symptomatic or asymptomatic VTE

Time Frame: 5~14 days after CRC surgery (by doppler venous ultrasound [US]) or the follow-up period of postoperative 1 month

To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler US during postoperative periods in patients with CRC receiving surgery

Secondary Outcomes

  • Risk factors for the development of VTE(5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month)

Study Sites (1)

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