Socioeconomic Position in Acute Colorectal Cancer Surgery
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|ClinicalTrials.gov Identifier: NCT03581890|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
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:
- 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.
- To examine if there is an association between education, income, cohabitation, or urbanicity and 1-year mortality after acute colorectal cancer surgery.
|Condition or disease||Intervention/treatment|
|Colorectal Neoplasms Malignant||Other: Socioeconomic position|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||35000 participants|
|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|
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.
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:
- Incidence of acute colorectal cancer surgery (study 1) [ Time Frame: At the time of surgery ]
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.
- Postoperative 1-year mortality rate (study 2) [ Time Frame: Within 365 days of surgery ]1-year mortality after acute colorectal cancer surgery
- Postoperative 90-day mortality (study 2) [ Time Frame: Within 90-days of surgery ]90-day mortality after acute colorectal cancer surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581890
|Principal Investigator:||Thea H. Degett, MD||Zealand University Hospital|