Socioeconomic Position in Acute Colorectal Cancer Surgery

NCT03581890 | Unknown

• 1 other identifier: 2015-41-3726
• Study Type: observational
• Target: 35,000
• Locations: 0 countries
• Sites: N/A

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. 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. 2.To examine if there is an association between education, income, cohabitation, or urbanicity and 1-year mortality after acute colorectal cancer surgery.

Conditions

Colorectal Neoplasms Malignant

Keywords

Colorectal cancer; Socioeconomic position

Outcome Measures

Primary Outcomes (2)

• 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.

  At the time of surgery

• Postoperative 1-year mortality rate (study 2)

  1-year mortality after acute colorectal cancer surgery

  Within 365 days of surgery

Secondary Outcomes (1)

• Postoperative 90-day mortality (study 2)

  Within 90-days of surgery

Study Arms (1)

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

Interventions

Socioeconomic position OTHER

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).

Danish Colorectal Cancer Group (DCCG.dk) database

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Danish Cancer Society: collaborator

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Thea H. Degett, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: July 10, 2018
• Study Start: December 1, 2007
• Primary Completion: May 31, 2017
• Study Completion: July 31, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share