VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program

NCT ID: NCT06009484

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Deep Vein Thrombosis, Pulmonary Embolus Colon Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Colon resection

Colon cancer resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claus A Bertelsen, Ph.D.

Role: STUDY_CHAIR

Copenhagen University Hospital - North Zealand

Other Identifiers

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VTE-1

Identifier Type: -

Identifier Source: org_study_id

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