Incidence of Venous Thromboembolism Following Surgery in Patients With Colorectal Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Symptomatic Venous Thromboembolism Asymptomatic Venous Thromboembolism |
Procedure: CRC surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Incidence of Venous Thromboembolism Following Surgery in Korean Patients With Colorectal Cancer; a Prospective Study |
- 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 ] [ Designated as safety issue: No ]To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler US during postoperative periods in patients with CRC receiving surgery
- Risk factors for the development of VTE [ Time Frame: 5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month ] [ Designated as safety issue: No ]To identify risk factors for the development of VTE in this population
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group A
Patients who gave a permission to this study and underwent doppler US (Doppler US cohort - Expected subject no.: 400 patients |
Procedure: 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 |
Procedure: 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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with CRC receiving curative or palliative surgery
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
Contacts and Locations| Contact: Keun-Wook Lee, M.D. & Ph.D. | 82-31-787-7009 | hmodoctor@hanmail.net |
| Korea, Republic of | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam, Gyeonggi-do, Korea, Republic of, 463-707 | |
| Contact: Keun-Wook Lee, M.D.. & Ph.D. 82-31-787-7009 hmodoctor@hanmail.net | |
| Sub-Investigator: Jee Hyun Kim, M.D. & Ph.D. | |
| Sub-Investigator: Sung-Bum Kang, M.D. & Ph.D. | |
| Sub-Investigator: Duck-Woo Kim, M.D. & Ph.D. | |
| Sub-Investigator: Jin Won Kim, M.D. | |
| Sub-Investigator: Sang Il Choi, M.D. & Ph.D. | |
| Sub-Investigator: Eun Ju Chun, M.D. & Ph.D. | |
| Sub-Investigator: Soo Mee Bang, M.D. & Ph.D. | |
| Sub-Investigator: Jeong-Ok Lee, M.D. | |
More Information
No publications provided
| Responsible Party: | Keun-Wook Lee, Principal investigator, Seoul National University Bundang Hospital |
| ClinicalTrials.gov Identifier: | NCT01567917 History of Changes |
| Other Study ID Numbers: | CRC-SNUBH-2012-01 |
| Study First Received: | March 28, 2012 |
| Last Updated: | March 29, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Bundang Hospital:
|
Venous thromboembolism Colorectal cancer Postoperative period detected on 5th~14th days after surgery (by doppler US) or the follow-up period of postoperative 1 month |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Thromboembolism Venous Thromboembolism Venous Thrombosis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on May 23, 2013