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Incidence of Venous Thromboembolism Following Surgery in Patients With Colorectal Cancer

29. marts 2012 opdateret af: Keun-Wook Lee, Seoul National University Bundang Hospital

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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Forventet)

600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republikken, 463-707
        • Rekruttering
        • Seoul National University Bundang Hospital
        • Kontakt:
        • Underforsker:
          • Jee Hyun Kim, M.D. & Ph.D.
        • Underforsker:
          • Sung-Bum Kang, M.D. & Ph.D.
        • Underforsker:
          • Duck-Woo Kim, M.D. & Ph.D.
        • Underforsker:
          • Jin Won Kim, M.D.
        • Underforsker:
          • Sang Il Choi, M.D. & Ph.D.
        • Underforsker:
          • Eun Ju Chun, M.D. & Ph.D.
        • Underforsker:
          • Soo Mee Bang, M.D. & Ph.D.
        • Underforsker:
          • Jeong-Ok Lee, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with CRC receiving curative or palliative surgery

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of symptomatic or asymptomatic VTE
Tidsramme: 5~14 days after CRC surgery (by doppler venous ultrasound [US]) or the follow-up period of postoperative 1 month
To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler US during postoperative periods in patients with CRC receiving surgery
5~14 days after CRC surgery (by doppler venous ultrasound [US]) or the follow-up period of postoperative 1 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Risk factors for the development of VTE
Tidsramme: 5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month
To identify risk factors for the development of VTE in this population
5~14 days after CRC surgery (by doppler US) or the follow-up period of postoperative 1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2011

Primær færdiggørelse (Forventet)

1. juni 2013

Studieafslutning (Forventet)

1. december 2013

Datoer for studieregistrering

Først indsendt

28. marts 2012

Først indsendt, der opfyldte QC-kriterier

29. marts 2012

Først opslået (Skøn)

30. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med CRC surgery

3
Abonner