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

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

Detailed Description
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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.

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

Conditions
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Pediatric Inflammatory Bowel Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011. Exclusion Criteria: None

Ages Eligible for Study
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Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of surgical resection in CD and colectomy in pediatric UC | 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. | end of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease extension according to Montreal classification | Phenotype of MICI maximum monitoring (Montreal classification), according to the date of diagnosis | end of follow up | 
| Treatment during the follow up | treatment | end of follow up | 
| information about occurrence of postoperative complications | Presence, date and type of occurrence of postoperative complications (Dindo classification). | end of follow up | 
| Weight and size | Weight and size at diagnosis, at the first intestinal resection and at the end of follow up | end of follow up | 
| Hospitalisations | number, duration, date | end of follow up | 
| Studies category Socio-Professional | Studies category Socio-Professional (CSP) and occupation | end of follow up | 
| Age of puberty | Age of puberty | end of follow up | 
| Death | Death and if so; due date and | end of follow up | 
| Complications | Serious infectious complications and cancer | end of follow up | 
| cost-effectiveness evalutation of different management strategies of IBD | cost-effectiveness evalutation of different management strategies of IBD according comparison of groups of patients | end of follow up | 
| cost-effectiveness evalutation of different management strategies of IBD | cost-effectiveness evalutation of different management strategies of IBD according the period of diagnosis | end of follow up | 
| cost-effectiveness evalutation of different management strategies of IBD | cost-effectiveness evalutation of different management strategies of IBD according Markov model of disease natural history | end of follow up | 
| Variation of cost-effectiveness ratio of IBD treatment strategies | Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries. | at 5 years | 
| Variation of cost-effectiveness ratio of IBD treatment strategies | Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries. | at 15 years | 
| Variation of cost-utility ratio of IBD treatment strategies | Variation of cost-utility ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries. | at 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease (CD), Pediatric, Inflammatory Bowel Disease