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NCT06009484 Clinical Trial

VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06009484
Other study ID # VTE-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date March 15, 2018

Study information
Verified date August 2023
Source Nordsjaellands Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2141
Est. completion date March 15, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Colon resection
Colon cancer resection

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Nordsjaellands Hospital Bispebjerg Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative venous thromboembolic event Deep venous thrombosis or pulmonary embolism 60 days
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