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:
Condition or disease | Intervention/treatment |
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Colorectal Neoplasms Malignant | Other: Socioeconomic position |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 35000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Is Socioeconomic Position Associated With Acute Onset of Colon Cancer and 1-year Mortality After Acute Colon Cancer Surgery |
Actual Study Start Date : | December 1, 2007 |
Actual Primary Completion Date : | May 31, 2017 |
Estimated Study Completion Date : | July 31, 2018 |
Group/Cohort | Intervention/treatment |
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Danish Colorectal Cancer Group (DCCG.dk) database
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.
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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:
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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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion criteria:
First study
Second study
Exclusion criteria:
Both studies:
Second study:
Principal Investigator: | Thea H. Degett, MD | Zealand University Hospital |
Tracking Information | |||||
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First Submitted Date | March 22, 2018 | ||||
First Posted Date | July 10, 2018 | ||||
Last Update Posted Date | July 10, 2018 | ||||
Actual Study Start Date | December 1, 2007 | ||||
Actual Primary Completion Date | May 31, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
Postoperative 90-day mortality (study 2) [ Time Frame: Within 90-days of surgery ] 90-day mortality after acute colorectal cancer surgery
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Socioeconomic Position in Acute Colorectal Cancer Surgery | ||||
Official Title | Is Socioeconomic Position Associated With Acute Onset of Colon Cancer and 1-year Mortality After Acute Colon Cancer Surgery | ||||
Brief Summary |
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:
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Detailed Description |
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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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 1 Year | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population |
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. |
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Condition | Colorectal Neoplasms Malignant | ||||
Intervention | 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:
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Study Groups/Cohorts | Danish Colorectal Cancer Group (DCCG.dk) database
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.
Intervention: Other: Socioeconomic position
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
35000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 31, 2018 | ||||
Actual Primary Completion Date | May 31, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion criteria: First study
Second study
Exclusion criteria: Both studies:
Second study:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03581890 | ||||
Other Study ID Numbers | 2015-41-3726 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Zealand University Hospital | ||||
Study Sponsor | Zealand University Hospital | ||||
Collaborators | Danish Cancer Society | ||||
Investigators |
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PRS Account | Zealand University Hospital | ||||
Verification Date | July 2018 |