NCT03476707

Brief Summary

The objective is to measure the adjusted association between preoperative anemia and total hospital costs. We hypothesize that patients with anemia before surgery will have higher hospitalization costs than people without anemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
851

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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, 2010

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

September 24, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

6.9 years

First QC Date

March 19, 2018

Results QC Date

July 12, 2023

Last Update Submit

September 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total Hospital Costs

    Direct and indirect costs accrued during the index hospitalization. Costs were measured using standard and validated algorithms, standardized to 2016 CAD. This method accounts for a patient's resource intensity weight, their case mix group, as well as fixed patient costs (e.g., medications, investigations) and indirect costs to the hospital based on patient's location of care (intensive care unit versus ward) and length of stay.

    Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first

Secondary Outcomes (2)

  • Length of Stay

    Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)

  • Red Blood Cell Transfusion

    Hospital admission to date of surgery, or 365 days after admission, whichever came first

Study Arms (2)

Anemic

People with a preoperative hematocrit less than 0.39

Other: Anemia

Non-anemic

People with a preoperative hematocrit greater than or equal to 0.39

Interventions

AnemiaOTHER

Hematocrit less than 0.39

Anemic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults having elective colorectal surgery with national surgical quality improvement program data available

You may qualify if:

  • Elective hospital admission
  • having colorectal surgery

You may not qualify if:

  • not enrolled in national surgical quality improvement program data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Feng S, Greenberg J, Moloo H, Thavorn K, McIsaac DI. Hospital cost associated with anemia in elective colorectal surgery: a historical cohort study. Can J Anaesth. 2019 Aug;66(8):877-885. doi: 10.1007/s12630-019-01379-8. Epub 2019 May 1.

MeSH Terms

Conditions

Blood Loss, SurgicalAnemiaColonic Neoplasms

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsHematologic DiseasesHemic and Lymphatic DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Limitations and Caveats

Findings may not be generalizable to other jurisdictions with different hospital funding models and findings provide only an association between anemia and costs. There is risk of confounding bias due to unmeasured variables that might influence the presence of anemia or the accumulation of costs. The lack of integration of transfusion costs in our healthcare system required us to estimate the added cost of transfusions, and we were also unable to account for physician remuneration costs.

Results Point of Contact

Title
Dr. Daniel McIsaac
Organization
The Ottawa Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 26, 2018

Study Start

January 1, 2010

Primary Completion

December 1, 2016

Study Completion

March 1, 2018

Last Updated

September 24, 2024

Results First Posted

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share