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临床试验/NCT03581890
NCT03581890Unknown不适用

Is Socioeconomic Position Associated With Acute Onset of Colon Cancer and 1-year Mortality After Acute Colon Cancer Surgery

Zealand University Hospital0 个研究点目标入组 35,000 人开始时间: 2007年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
35,000
主要终点
Postoperative 1-year mortality rate (study 2)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Postoperative 1-year mortality rate (study 2)

时间窗: Within 365 days of surgery

1-year mortality after acute colorectal cancer surgery

Incidence of acute colorectal cancer surgery (study 1)

时间窗: 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.

次要结局

  • Postoperative 90-day mortality (study 2)(Within 90-days of surgery)

研究者

申办方类型
Other
责任方
Sponsor

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