Incidence of Venous Thromboembolism Following Surgery in Patients With Colorectal Cancer
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.
研究概览
地位
干预/治疗
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Keun-Wook Lee, M.D. & Ph.D.
- 电话号码:82-31-787-7009
- 邮箱:hmodoctor@hanmail.net
学习地点
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Gyeonggi-do
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Seongnam、Gyeonggi-do、大韩民国、463-707
- 招聘中
- Seoul National University Bundang Hospital
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接触:
- Keun-Wook Lee, M.D.. & Ph.D.
- 电话号码:82-31-787-7009
- 邮箱:hmodoctor@hanmail.net
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副研究员:
- Jee Hyun Kim, M.D. & Ph.D.
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副研究员:
- Sung-Bum Kang, M.D. & Ph.D.
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副研究员:
- Duck-Woo Kim, M.D. & Ph.D.
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副研究员:
- Jin Won Kim, M.D.
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副研究员:
- Sang Il Choi, M.D. & Ph.D.
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副研究员:
- Eun Ju Chun, M.D. & Ph.D.
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副研究员:
- Soo Mee Bang, M.D. & Ph.D.
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副研究员:
- Jeong-Ok Lee, M.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
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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 |
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 |
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 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The incidence of symptomatic or asymptomatic VTE
大体时间:5~14 days after CRC surgery (by doppler venous ultrasound [US]) or the follow-up period of postoperative 1 month
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To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler US during postoperative periods in patients with CRC receiving surgery
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5~14 days after CRC surgery (by doppler venous ultrasound [US]) or the follow-up period of postoperative 1 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Risk factors for the development of VTE
大体时间:5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month
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To identify risk factors for the development of VTE in this population
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5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
CRC surgery的临床试验
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University of California, San FranciscoSan Francisco State University; NICOS Chinese Health Coalition完全的
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Memorial Sloan Kettering Cancer CenterCANCER PREVENTION FUND招聘中
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Digital Health Navigation Solutions, IncNational Cancer Institute (NCI); Wake Forest University Health Sciences尚未招聘
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI)招聘中
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