Deep Vein Thrombosis, Pulmonary EmbolusNCT06009484
VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program
An observational study of Deep Vein Thrombosis, Pulmonary Embolus and Colon Cancer, run by Nordsjaellands Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Pulmonary Embolus, Colon Cancer
- What is being tested?
- Colon resection
- Type of treatment
- Surgery or procedure
- How many people
- 2,141 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 15 Mar 2018
- How long will I take part?
- 60 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- elective macroradical resection for UICC Stage I-III colonic adenocarcinoma
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Colon resection
- Keywords
- Prolonged thromboembolic prophylaxis
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon resectionProcedure or surgery
Colon cancer resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative venous thromboembolic event
Deep venous thrombosis or pulmonary embolism
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis, Pulmonary EmbolusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,141 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital
- Responsible party
- Sponsor
- Investigators
- Claus A Bertelsen, Ph.D., Study chair, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009484
- Sponsor's protocol ID
- VTE-1
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Venous Thrombotic Event After Curative Colon Cancer Surgery in an Enhanced Recovery After Surgery Program
- ClinicalTrials.gov ID
- NCT06009484
- Acronym / sponsor ID
- VTE-1
- Keywords
- Prolonged thromboembolic prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,141 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- elective macroradical resection for UICC Stage I-III colonic adenocarcinoma
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colon resectionColon cancer resection | Procedure or surgery | – |
Primary outcome
Postoperative venous thromboembolic event
Time frame: 60 days
Deep venous thrombosis or pulmonary embolism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Deep Vein Thrombosis, Pulmonary Embolus
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingObservational study
TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization
Lower Extremity Injuries, Venous Thromboembolism (VTE)
Not yet recruitingPhase 4
Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
Venous Thromboembolism, Active Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus A Bertelsen, Ph.D. study chair
Copenhagen University Hospital - North Zealand
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, Pulmonary Embolus and Colon Cancer, run by Nordsjaellands Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative venous thromboembolic event (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.