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临床试验/NCT02686892
NCT02686892已完成不适用

An Epidemiological Study of the Incidence of Inflammatory Bowel Disease in Spain

Javier P. Gisbert16 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,000
试验地点
16
主要终点
Number of participants with the incidence of inflammatory bowel disease in Spain

研究概览

简要总结

This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 1 year in Spain.

In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.

详细描述

Study design This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 1 year in Spain.

In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.

Study population Incident cases diagnosed with IBD over 12 months in the Spanish territory, which has a population of 46,439,864 inhabitants (1 January 2015) according to data from the National Statistics Institute (INE). According to recent data, only 3% of incident cases are diagnosed in the pediatric population, so the study will focus on adult patients (over 15 years of age).

Case detection In Spain, health care is performed mostly by the public health services. According to recent data, approximately 15% of the Spanish population has private health insurance (Informe Sanidad Privada: Aportando Valor. Análisis de situación 2014 (Report on Private Health Care: Providing Value. 2014 Situation Analysis); available at: https://www.fundacionidis.com/wp-content/informes/informe_analisis situac_2014_0.pdf). In addition, of those persons having private health insurance, only about 15% make exclusive use of it. For these reasons and taking into account the specific characteristics of IBD, the risk of underestimating the incidence of IBD considering only cases seen in public health centers would be of little relevance. Therefore, this study will be conducted at centers providing public health care within the National Health System.

Furthermore, as previously mentioned, according to recent data only 3% of incident cases are diagnosed in the pediatric population, so the study will focus on adult patients (over 16 years of age)4.

研究设计

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

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

  • Patients over 18 years of age diagnosed with IBD.
  • Diagnosis of IBD according to European Crohns and Colitis Organisation (ECCO) criteria.
  • The patient must belong to the health area of one of the participating center

排除标准

  • Patients who do not accept to participate in the study

结局指标

主要结局

Number of participants with the incidence of inflammatory bowel disease in Spain

时间窗: 1 year

次要结局

  • Number of patients with incidece of inflammatory bowel disease in diferent regions of the spanish territory(1 year)
  • Delay from onset of symptoms to diagnosis of the disease(1 year)
  • Resourses used in the first year after diagnosis.(1 year)
  • Characteristics of patients at diagnosis of inflammatory bowel disease(1 year)

研究者

发起方
Javier P. Gisbert
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Javier P. Gisbert

MD PhD

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

研究点 (16)

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