- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476707
Association of Anemia With Hospital Costs in Elective Colorectal Surgery
March 23, 2018 updated by: Ottawa Hospital Research Institute
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study will examine the association between preoperative anemia (hematocrit less than 0.39; low blood counts) and hospital total costs from elective colorectal surgery.
Total costs will be defined as the combination of direct and indirect costs ascertained using standardized patient-level costing algorithms (i.e. the standard way that hospital measure their costs).
Adjustment will be made for factors that are likely to influence both the presence of anemia and costs of care.
Study Type
Observational
Enrollment (Actual)
1000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adults having elective colorectal surgery with national surgical quality improvement program data available
Description
Inclusion Criteria:
- Elective hospital admission
- having colorectal surgery
Exclusion Criteria:
- not enrolled in national surgical quality improvement program data collection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Anemic
People with a preoperative hematocrit less than 0.39
|
Hematocrit less than 0.39
|
Non-anemic
People with a preoperative hematocrit greater than or equal to 0.39
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total hospital costs
Time Frame: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
|
Direct and indirect costs accrued during the index hospitalization
|
Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)
|
Number of days in hospital after surgery
|
Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)
|
Red blood cell transfusion
Time Frame: Hospital admission to date of surgery, or 365 days after admission, whichever came first
|
Any red blood cell transfusion received
|
Hospital admission to date of surgery, or 365 days after admission, whichever came first
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (Actual)
March 26, 2018
Study Record Updates
Last Update Posted (Actual)
March 27, 2018
Last Update Submitted That Met QC Criteria
March 23, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DM9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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