SurgeryNCT03476707
Association of Anemia With Hospital Costs in Elective Colorectal Surgery
An observational study of Surgery and Surgical Blood Loss, run by Ottawa Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Surgical Blood Loss, Anemia
- What is being tested?
- Anemia
- How many people
- 851 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: All adults having elective colorectal surgery with national surgical quality improvement program data available
Who may be able to join
- Elective hospital admission
- having colorectal surgery
Who cannot join
- not enrolled in national surgical quality improvement program data collection
About this study
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.
Read the 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.
- Conditions
- Surgery, Surgical Blood Loss, Anemia, Colon Cancer, Economic Problems
- Being tested
- Anemia
- Medical subject headings
- Blood Loss, Surgical, Anemia, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnemiaOther
Hematocrit less than 0.39
| Study group | Role | What they receive |
|---|---|---|
| Anemic | People with a preoperative hematocrit less than 0.39 Receives: Other: Anemia | |
| Non-anemic | People with a preoperative hematocrit greater than or equal to 0.39 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first
Secondary outcomes (2)
Length of Stay
Number of days in hospital after surgery
Measured: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)
Red Blood Cell Transfusion
Any red blood cell transfusion received
Measured: Hospital admission to date of surgery, or 365 days after admission, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study startJan 2010
- Primary completionDec 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476707
- Sponsor's protocol ID
- DM9
- Status last verified
- Sep 2024
- First submitted
- 19 Mar 2018
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31044414
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Anemia With Hospital Costs in Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03476707
- Acronym / sponsor ID
- DM9
- Conditions
- Surgery, Surgical Blood Loss, Anemia, Colon Cancer, Economic Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemic | – | Other: AnemiaPeople with a preoperative hematocrit less than 0.39 |
| Non-anemic | – | –People with a preoperative hematocrit greater than or equal to 0.39 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults having elective colorectal surgery with national surgical quality improvement program data available
Key inclusion criteria (2 listed)
- Elective hospital admission
- having colorectal surgery
Key exclusion criteria (1 listed)
- not enrolled in national surgical quality improvement program data collection
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 |
|---|---|---|
| AnemiaHematocrit less than 0.39 | Other | Anemic |
Primary outcome
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. 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.
2 secondary outcomes
Length of Stay
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31044414Feng 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Surgical Blood Loss, run by Ottawa Hospital Research Institute.
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 2 inclusion and 1 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 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Hospital Costs (time frame: Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476707, which also lists 1 linked publication.
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 Sep 2024.