Colorectal Neoplasms Malignant Clinical Trial
Official title:
Is Socioeconomic Position Associated With Acute Onset of Colon Cancer and 1-year Mortality After Acute Colon Cancer Surgery
Acute colon cancer surgery has a poor 90-day mortality of 21.0% compared with only 3% after
elective colorectal cancer surgery in Denmark. The high mortality after acute colon cancer
surgery compared with elective surgery emphasizes the importance of identifying factors
associated with acute onset and poor short-term survival after acute surgery. Socioeconomic
position has previously showed to be a risk factor for acute versus elective onset of
colorectal cancer. Furthermore, if patients with low socioeconomic position have higher
postoperative mortality this could reflect differences in the treatment of patients according
to their socioeconomic position.
The aim of the clinical study is:
1. To examine if patients with short education, low income, living alone, or living in
rural areas are more likely to undergo acute colorectal cancer surgery than elective
surgery compared with patients with longer educations, higher income, living with a
partner, or living in urban areas.
2. To examine if there is an association between education, income, cohabitation, or
urbanicity and 1-year mortality after acute colorectal cancer surgery.
Hypothesis
The investigators hypothesize that patients with short education, low income, living alone,
or living in rural areas are, themselves or their physician, less likely to react to
unspecified symptoms of colon cancer and have a higher risk of acute onset due to more
progressed disease compared with patients with a higher socioeconomic position. Furthermore,
the hypothesis is that there is an association between socioeconomic position and 90-day
mortality after acute colorectal surgery, explained by patient, treatment or organizational
related factors.
Methods
The study is a nationwide, historical cohort study with prospective collected data. All
patients in Denmark will be followed up one year after surgery. Exposure is socioeconomic
position measured by highest attained education, age and sex-adjusted income, cohabitation
status, and urbanicity. Primary outcome in the first study is acute surgical procedure for
colorectal cancer. Primary outcome in the second study is year mortality after acute
colorectal cancer surgery or insertion of self-expanding metallic stent (SEMS).
Analysis
First study:
Differences in socioeconomic position between patients undergoing acute and elective CRC
surgery will be explored with a logistic regression model. We will include the following
covariates in the analysis:
Confounders: age, sex.
Mediators: comorbidity (Charlson Comorbidity Index), BMI (Body Mass Index), alcohol,
UICC-stage (The Union for International Cancer Control), smoking, tumor localization, income,
education, cohabitation, urbanicity A sensitivity analysis will be conducted to examine if
department volume adds to the effect of urbanicity.
Second study:
Differences in socioeconomic position in postoperative 1-year mortality after acute
colorectal cancer surgery will be analysed with a cox regression model. We will include the
following covariates in the analysis:
Confounders: age, sex.
Mediators: comorbidity (Charlson Comorbidity Index), BMI (Body Mass Index), alcohol,
UICC-stage (The Union for International Cancer Control), smoking, tumor localization, income,
education, cohabitation, urbanicity A sensitivity analysis will be conducted to examine if
department volume adds to the effect of urbanicity.
Ethical considerations
The project has been approved by the Danish Data Protection Agency with journal no. 2015-41-
3726. Data will be handled according to Danish law and the Helsinki declaration. This study
does not require written content from the participants, thus all data is retracted from
databases and registries.
In the presentation of final results all patients will remain anonymous and not identifiable
according to Danish law. All data will be kept a minimum of 5 years.
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