VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program

August 18, 2023 updated by: Nordsjaellands Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective macroradical resection for UICC Stage I-III colonic adenocarcinoma in the Capital Region of Denmark between January 1, 2014, and December 31, 2017. The database does not include acute cases, cases of metachronous colorectal cancers or rectal cancers without synchronous colonic adenocarcinoma.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative venous thromboembolic event
Time Frame: 60 days
Deep venous thrombosis or pulmonary embolism
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Collaborators

Hvidovre University Hospital
Bispebjerg Hospital
Herlev and Gentofte Hospital

Investigators

  • Study Chair: Claus A Bertelsen, Ph.D., Copenhagen University Hospital - North Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

March 15, 2018

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTE-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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