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OpenTrials
Completed

NCT Number: NCT06009484

VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program

Based on data on a cohort of 2,141 patients undergoing elective colonic cancer resection in an ERAS program, the incidence of postoperative thromboembolic events is estimated in patients no receiving prolonged thromboembolic prophylaxis.

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Key information

About this study

The Copenhagen cOmplete Mesocolic Excision Study (COMES) database contains comprehensive data on preoperative, intraoperative, postoperative and tumor related variable on patients undergoing elective colonic cancer resection at four public university clinics providing all colorectal cancer treatment for the 1.8 million residents of the Capital Region of Denmark during the period 2014-2017.

None of these hospitals had implemented prolonged thromboembolic prophylaxis after discharge.

The medical records were reviewed with focusing on VTE prophylaxis, ongoing preoperative and postoperative anticoagulant treatment, the length of hospital stay (LOS), and readmission to ensure high data validity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective macroradical resection for UICC Stage I-III colonic adenocarcinoma

Exclusion criteria

  • concomitant rectum resection
  • soly appendix carcinoma
  • diagnosed with pulmonary embolism or deep venous thrombosis before primary discharge
  • dying before discharge from the hospital or discharged at postoperative day 28 or later
  • treatment with vitamin K antagonists, heparin or new oral anticoagulants before or after surgery
  • VTE less than 3 months before the colon resection

Treatment and study plan

Colon resection

Procedure

Colon cancer resection

Primary outcomes

  1. Postoperative venous thromboembolic event

    Time frame: 60 days

    Deep venous thrombosis or pulmonary embolism

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Bispebjerg Hospital
  • Herlev and Gentofte Hospital
  • Hvidovre University Hospital

Registry information

Official study title

Incidence of Venous Thrombotic Event After Curative Colon Cancer Surgery in an Enhanced Recovery After Surgery Program

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Aug 24, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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