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Symptomatic Venous ThromboembolismNCT01567917

Incidence of Venous Thromboembolism Following Surgery in Patients With Colorectal Cancer

An observational study of Symptomatic Venous Thromboembolism and Asymptomatic Venous Thromboembolism, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
CRC surgery
Type of treatment
Surgery or procedure
How many people
600 participants
Where
1 siteSouth Korea
Study dates
Jun 2011to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with CRC receiving curative or palliative surgery

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Keun-Wook Lee, M.D. & Ph.D. contact

82-31-787-7009

hmodoctor@hanmail.net

South Korea1 site, 1 recruiting
  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

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

    Jee Hyun Kim, M.D. & Ph.D.

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Being tested
CRC surgery
Keywords
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
Medical subject headings
Venous Thromboembolism, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRC surgeryProcedure or 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
Study groups in NCT01567917
Study groupRoleWhat they receive
Group APatients who gave a permission to this study and underwent doppler US (Doppler US cohort - Expected subject no.: 400 patients
Receives: Procedure: CRC surgery
Group BPatient 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
Receives: Procedure: CRC surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of symptomatic or asymptomatic VTE

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

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

Secondary outcomes (1)
  1. Risk factors for the development of VTE

    To identify risk factors for the development of VTE in this population

    Measured: 5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2012 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01567917
Sponsor's protocol ID
CRC-SNUBH-2012-01
Status last verified
Mar 2012
First submitted
28 Mar 2012
Last updated
30 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Symptomatic Venous Thromboembolism and Asymptomatic Venous Thromboembolism, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Keun-Wook Lee, M.D. & Ph.D. (82-31-787-7009, hmodoctor@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.

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