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

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

Study Overview

• Status: Completed
• Conditions: Pediatric Inflammatory Bowel Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 966

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • CHRU Lille
  • Rouen, France, 7700
    • CHU Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric IBD patients in the area of EPIMAD registry Age of diagnosis < 17 years

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Funding from DGOS (PHRC IR 2013 and PRME)
• Investigators: Study Director: Mathurin Fumery, Doctor, CHU Amiens France; Study Director: Jean-Louis Dupas, professor, CHU Amiens France

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pediatric; Inflammatory Bowel Disease; Crohn's disease (CD)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: PI2013_843_0022