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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
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Zealand University Hospital

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:

  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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Malignant Other: Socioeconomic position

  Show Detailed Description

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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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:

  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).




Primary Outcome Measures :
  1. 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.


  2. Postoperative 1-year mortality rate (study 2) [ Time Frame: Within 365 days of surgery ]
    1-year mortality after acute colorectal cancer surgery


Secondary Outcome Measures :
  1. 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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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
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.

Criteria

Inclusion criteria:

First study

  • All patients undergoing a surgical procedure for colorectal cancer in Denmark and registered in the Danish Colorectal Cancer Group (DCCG.dk) database from 1st of January 2007 to 31st of December 2016. If a patient dies during surgery, they will also be included.

Second study

  • All patients operated for acute colorectal cancer in Denmark from 1st of January 2007 to 31st of December 2016 and registered in the DCCG.dk database. Acute surgery can either be colectomy, placement of self-expanding metallic stent, diverting stoma, or damage control surgery. If a patient dies during surgery, they will also be included.

Exclusion criteria:

Both studies:

  • Not registered In the DCCG.dk database with a colorectal cancer diagnose.
  • Missing on income, urbanicity, cohabitation, or UICC-stage.

Second study:

  • Registered in the DCCG.dk database with an elective surgical procedure without a registration of SEMS or diverting stoma 72 hours before an emergency admission in NPR.
  • lost to follow-up one year postoperative.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Zealand University Hospital
Danish Cancer Society
Investigators
Principal Investigator: Thea H. Degett, MD Zealand University Hospital

Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03581890     History of Changes
Other Study ID Numbers: 2015-41-3726
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Since the data belongs to the DCCG.dk database, it is not possible to share them.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zealand University Hospital:
Colorectal cancer
Socioeconomic position

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases