Pediatric GI Endoscopy at Assiut University
NCT07239934
Chronic Diarrhea, Deglutition Disorders
Asyut, Asyut Governorate, Egypt
View Trial DetailsNCT Number: NCT02392221
Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.
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Notify MeUp to 26 year
All sexes
Observational
CHRU Lille, Lille, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.
Exclusion criteria
Time frame: 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.
Time frame: end of follow up
Phenotype of MICI maximum monitoring (Montreal classification), according to the date of diagnosis
Time frame: end of follow up
treatment
Time frame: end of follow up
Presence, date and type of occurrence of postoperative complications (Dindo classification).
Time frame: end of follow up
Weight and size at diagnosis, at the first intestinal resection and at the end of follow up
Time frame: end of follow up
number, duration, date
Time frame: end of follow up
Studies category Socio-Professional (CSP) and occupation
Time frame: end of follow up
Age of puberty
Time frame: end of follow up
Death and if so; due date and
Time frame: end of follow up
Serious infectious complications and cancer
Time frame: end of follow up
cost-effectiveness evalutation of different management strategies of IBD according comparison of groups of patients
Time frame: end of follow up
cost-effectiveness evalutation of different management strategies of IBD according the period of diagnosis
Time frame: end of follow up
cost-effectiveness evalutation of different management strategies of IBD according Markov model of disease natural history
Time frame: at 5 years
Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.
Time frame: at 15 years
Variation of cost-effectiveness ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.
Time frame: at 15 years
Variation of cost-utility ratio of IBD treatment strategies. Efficacy will be measured with number of avoided surgeries.
Centre Hospitalier Universitaire, Amiens
Other
Acronym: Inspired
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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