NCT06009484

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,141

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

4 years

First QC Date

August 18, 2023

Last Update Submit

August 18, 2023

Conditions

Deep Vein Thrombosis, Pulmonary EmbolusColon Cancer

Keywords

Prolonged thromboembolic prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Postoperative venous thromboembolic event

    Deep venous thrombosis or pulmonary embolism

    60 days

Interventions

Colon resectionPROCEDURE

Colon cancer resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismColonic Neoplasms

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Claus A Bertelsen, Ph.D.

    Copenhagen University Hospital - North Zealand

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 24, 2023

Study Start

January 1, 2014

Primary Completion

December 31, 2017

Study Completion

March 15, 2018

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share