An observational study in Colorectal Neoplasms Malignant, sponsored by Zealand University Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-10.
Sponsored by Zealand University Hospital · Observational
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:
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.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's planned enrollment of 35,000 is above the median of 262 across 363 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Zealand University Hospital is the lead sponsor of 236 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is retracted from the Danish Colorectal Cancer Group (DCCG.dk) database. See description of the database in cohort description.
Information regarding highest attained education, age- and sex-adjusted income, cohabitation, and urbanicity will be collected from the registry of education and knowledge, registry of labor, income and wealth, and registry of living conditions via Statistics Denmark, which are nation-wide register with information on health, income, education, family status and other social data from all Danish citizens.
From the National Patient Registry we collect data regarding SEMS and diverting stoma in relation to an emergency admission 72 hours before the procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
First study
Second study
Exclusion criteria:
Both studies:
Second study:
The DCCG.dk database is a national population-based, clinical database with a completeness proportion of 99% of all colorectal cancer patients in Denmark. Patients are included in the database if treated for or diagnosed with colorectal cancer at a public surgical department in Denmark. No patients underwent treatment for colorectal cancer at private hospitals in Denmark. Metachronous cancers, recurrence, and tumors of other histological origin than primary adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, medullary carcinoma, or undifferentiated carcinoma are not registered in the DCCG.dk database. The surgeon prospectively registers perioperative variables such as surgical priority, stent insertion and type of colectomy, and patient related variables. Information on postoperative mortality is imported to the database from the Danish Central Civil Registration Registry linking all Danish residents with a unique identification number.
Other: Socioeconomic position
Socioeconomic position is the exposure in both study 1 and 2. Four different socioeconomic measures will be tested. The primary socioeconomic position measure is highest attained education the year before surgery (short/medium/long). Secondary measures are: 1. age- and sex-adjusted available income the year before surgery 2. Cohabitation status at the year of surgery (living alone/living with a partner) at the year of surgery. 3. Urbanicity (in four officially, predefined categories).
Incidence of acute colorectal cancer surgery (study 1)
Acute surgery as the first surgical intervention for colorectal cancer. This is registered by the surgeon in the DCCG.dk database prior to surgery. A surgical procedure is registered as acute by the surgeon based on clinical symptoms of an abdominal crises and how fast the surgical procedure is performed after onset of acute symptoms. There was no defined time limit from onset of symptoms to onset of procedure in order to classify the procedure as acute. This was up to the surgeon who registered the patient.
Time frame: At the time of surgery
Postoperative 1-year mortality rate (study 2)
1-year mortality after acute colorectal cancer surgery
Time frame: Within 365 days of surgery
Postoperative 90-day mortality (study 2)
90-day mortality after acute colorectal cancer surgery
Time frame: Within 90-days of surgery
No study locations are listed for this record.
Plan to share: No — Since the data belongs to the DCCG.dk database, it is not possible to share them.
No publications or documents are linked to this record.
Ran from Dec 2007 to primary completion in May 2017, 113 months.
Of 126 non-industry observational studies under Colonic Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 127. This study's 113 months is above that.
Counting every sponsor, half of 148 studies reached it within 51 months; a quarter within 27 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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