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.
調査の概要
状態
介入・治療
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Gyeonggi-do
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Seongnam、Gyeonggi-do、大韓民国、463-707
- 募集
- Seoul National University Bundang Hospital
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コンタクト：
- Keun-Wook Lee, M.D.. & Ph.D.
- 電話番号：82-31-787-7009
- メール：hmodoctor@hanmail.net
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副調査官：
- Jee Hyun Kim, M.D. & Ph.D.
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副調査官：
- Sung-Bum Kang, M.D. & Ph.D.
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副調査官：
- Duck-Woo Kim, M.D. & Ph.D.
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副調査官：
- Jin Won Kim, M.D.
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副調査官：
- Sang Il Choi, M.D. & Ph.D.
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副調査官：
- Eun Ju Chun, M.D. & Ph.D.
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副調査官：
- Soo Mee Bang, M.D. & Ph.D.
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副調査官：
- Jeong-Ok Lee, M.D.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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 |
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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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The incidence of symptomatic or asymptomatic VTE
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Risk factors for the development of VTE
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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