Pediatric Penetrating Crohn's Disease
Ключови думи
Резюме
Описание
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:
- description of the pediatric population with B3 complication with:
- demographic data: sex, family history, phenotype of the disease according to the Paris classification, age at diagnosis of B3, period of diagnosis of B3 (before or after 2001), time between the diagnosis of CD and the diagnosis of B3, a history of medical and surgical treatment for CD received before B3.
- clinical data: type of B3 complication, presence of stenosis and its location, clinical symptoms (fever, obstructive symptoms), nutritional status.
- description of the immediate management of these patients, specifying: the place of care, the type of immediate management performed, the drug treatments received in the acute phase, the medical treatments for CD introduced for the B3 episode, the intestinal resections performed for the B3 episode, the realization of a stoma, the radiological drainage of abscesses, the immediate complications of B3.
- description of the long-term evolution of these patients, specifying: the given drug treatments, the clinical recurrence of the CD, the recurrence of B3, the need for intestinal resection during follow-up, the occurrence of other events
- identification of risk factors for pejorative evolution defined by "recurrence of B3" or "intestinal resection" in these patients.
Дати
Последна проверка: | 09/30/2019 |
Първо изпратено: | 10/01/2019 |
Очаквано записване подадено: | 10/06/2019 |
Първо публикувано: | 10/07/2019 |
Изпратена последна актуализация: | 10/06/2019 |
Последна актуализация публикувана: | 10/07/2019 |
Действителна начална дата на проучването: | 08/31/2017 |
Приблизителна дата на първично завършване: | 08/31/2018 |
Очаквана дата на завършване на проучването: | 09/29/2018 |
Състояние или заболяване
Фаза
Критерии за допустимост
Полове, допустими за проучване | All |
Метод за вземане на проби | Non-Probability Sample |
Приема здрави доброволци | Да |
Критерии | Inclusion criteria: - 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: - patient having isolated perineal disease, indeterminate colitis or with too much missing data were excluded - patients refuse the use of medical data will be excluded. |
Резултат
Първични изходни мерки
1. incidence of intestinal resection performed for B3 complication in pediatric population [through study completion, an average of 10 years]
Вторични изходни мерки
1. incidence of recurrence of B3 complication in pediatric population [through study completion, an average of 10 years]
2. identification of risk factors for pejorative evolution (recurrence of