An observational study in Pediatric Penetrating Crohn's Disease, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by University Hospital, Montpellier · Observational
The incidence of Crohn's disease (CD) increased the last few years, especially in children, with 20% percent of CD patients diagnosed during childhood. The CD is a chronic disease without curative treatment, medical or surgical, and evolution is longer in children, avoid iterative digestive resections and their consequences in these patients is a major issue.
The beginning of the disease at pediatric age is considered to be a poor prognostic factor and is considered to be more aggressive than that of adults: more extensive, more active and requiring more immunosuppressive treatments, with a more frequent dependence on corticosteroids and a shorter delay between the beginning of symptoms and the first surgery. After 5 years of evolution, 13 to 50% of patients with early pediatric MC have undergone intestinal resection.
The Paris' classification defined 3 phenotypes or behaviors in pediatric Crohn's disease. Penetrating phenotype (B3) is a heterogeneous group defined by the presence of intra-abdominal perforation, fistulas or abscesses. The B3 phenotype is a risk factor for pejorative evolution in CD with a risk increased of surgical resection.
In the pediatric population, the natural history of patients with penetrating CD is unknown. Most studies focus on CD beginning at pediatric age but with penetrating complications occurring in adulthood or pediatric penetrating CD but with relatively short follow-up. The risk of recurrence of the penetrating disease after a first complication in childhood is unknown, the factors influencing this risk also. And, there is no consensus either concerning optimal B3 management in children, and the practices are variable from specialist to specialist.
After describing the pediatric population with penetrating CD, the aim of this study was to know the incidence of bowel resection for B3 episode. The secondary aims were to describe the immediate management and long-term evolution of these patients and to identify risk factors for adverse evolution.
This study is cross-sectional and is carrying out between 1995 and 2017 in two French tertiary referral centers (Montpellier, Toulouse) and EPIMAD registry which is currently the largest Inflammatory Bowel Disease cohort in world and cover 9.6% of French population (Nord, Pas-de-Calais, Somme, and Seine-Maritime department).
All patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon) before the age of 18. Patient having isolated perineal disease, indeterminate colitis or with too much missing data were excluded.
The main endpoint: incidence of intestinal resection performed for B3 complication.
The secondary endpoints:
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 500 is above the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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Patients diagnosed with CD who had underwent a B3 complication (intra-abdominal abscess, fistula, perforation, peritonitis, or phlegmon) before the age of 18
Exclusion criteria:
incidence of intestinal resection performed for B3 complication in pediatric population
* Incidence of intestinal resection at the first episode of B3 * Cumulated incidence of intestinal resection in the follow up.
Time frame: through study completion, an average of 10 years
incidence of recurrence of B3 complication in pediatric population
Incidence of recurrence of B3 complication and specifying : * median duration of recurrence after the first episode * number of recurrence
Time frame: through study completion, an average of 10 years
identification of risk factors for pejorative evolution (recurrence of <B3 or intestinal resection) of the pediatric population with B3 complication
Multivariate analysis with the following data to define parameters associated with "recurrence of B3" or "intestinal resection"
Time frame: through study completion, an average of 10 years.
Plan to share: Undecided — NC
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier