Incidence of Venous Thromboembolism Following Surgery in Patients With Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Keun-Wook Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01567917
First received: March 28, 2012
Last updated: March 29, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Study Population

Patients with CRC receiving curative or palliative surgery

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567917

Contacts
Contact: Keun-Wook Lee, M.D. & Ph.D. 82-31-787-7009 hmodoctor@hanmail.net

Locations
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.         
Sponsors and Collaborators
Seoul National University Bundang Hospital
  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 August 28, 2014