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临床试验/NCT02392221
NCT02392221已完成不适用

Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 966 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
966
试验地点
2
主要终点
Cumulative incidence of surgical resection in CD and colectomy in pediatric UC

研究概览

简要总结

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.

详细描述

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract. These are diseases of multifactorial origin in which environmental and genetic factors are predominant.The EPIMAD registry, the world's largest epidemiological register for IBD, identifying all incident cases in the four departments of the North West of France showed between 1988 and 2007, an increase in the annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p <0.0001) in the age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105 inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The increase in the incidence of CD will contribute to increase its weight in the health system, particularly in the pediatric CD frequently associated with an aggressive phenotype causing specific complications such as malnutrition, pubertal delay or thrive. These complications have a important impact on the quality of life with a long-term risk of functional disability. They may be associated with increased mortality. Immunosuppressants (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have profoundly changed the management of pediatric IBD. Although there is little data on the impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be associated with more frequent and deeper remission. With the advent of these new treatment, new therapeutic targets such as endoscopic mucosal healing and more recently the deep remission combining clinical remission, biological and endoscopic, appears. However there is no data in the general population assessing the impact of new treatments and new therapeutic strategies in the pediatric population. Potential risks associated with the increasing use and early use of biological treatments in this particular population remain to be determined in the general population.

The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed before 17 yeras old could influence the cumulative incidence of surgical resection and complications specific to this population as failure to thrive and delayed puberty, insertion socio-professional, the extension of the disease, hospitalization rates, and the rate of cancer.

研究设计

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

入排标准

年龄范围
— 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.

排除标准

  • 未提供

结局指标

主要结局

Cumulative incidence of surgical resection in CD and colectomy in pediatric UC

时间窗: end of follow up

Cumulative incidence of surgical resection in CD and colectomy in pediatric ulcerative colitis, depending on the date of diagnosis and the possibility of using immunosuppressants and / or anti-TNFs.

次要结局

  • Studies category Socio-Professional(end of follow up)
  • Disease extension according to Montreal classification(end of follow up)
  • information about occurrence of postoperative complications(end of follow up)
  • Weight and size(end of follow up)
  • Complications(end of follow up)
  • Hospitalisations(end of follow up)
  • Age of puberty(end of follow up)
  • Treatment during the follow up(end of follow up)
  • cost-effectiveness evalutation of different management strategies of IBD(end of follow up)
  • Variation of cost-effectiveness ratio of IBD treatment strategies(at 15 years)
  • Death(end of follow up)
  • Variation of cost-utility ratio of IBD treatment strategies(at 15 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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