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- Ensayo clínico NCT04837963
Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children
Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children ? A Case-control Study
Febrile urinary tract infection (FUTIs) are the most common bacterial infections in children under the age of 2 years. They represent 7% of children presenting with fever without a source. In case of recurrent or undertreated FUTIs there is a risk for kidney function with the threat of chronic renal failure [7]. They are more often isolated but some FUTIs may reveal an underlying and facilitating condition. Beside the well-known congenital anomalies of the kidneys and urinary tract such as reflux or obstructions, others risk factors for FUTI are reported. Age less than 1 year, uncircumcised males, poor fluid intake, bladder bowel dysfunction (BBD) including dysfunctional voiding pattern and constipation increase the risk of FUTI. The prevalence of BBD in children with FUTIs is far higher than in the general population. Recommendations emphasize on an efficient treatment of BBD in the first-line management of recurring FUTIs and it has been proven to be efficient (ref).
One of the BBD may include Hirschsprung's Disease (HD). HD is the first congenital malformation of the enteric nervous system with a reported prevalence of 1 in 5000 live birth. It's characterized by an aganglionosis and subsequent dysmotility affect by always the anal canal, most commonly there is a rectosigmoid form (74-80%), and less commonly involves a long segment of colon (12-22%) or a total colonic aganglionosis with ileal involvement upto 50 cm proximal to ileocecal junction (4-13%). The treatment is based on the resection of dysfunctional segment of colon with an anastomosis between the normally innervated bowel to the anus, while preserving normal sphincter function. But significant bowel dysfunction may persist postoperatively. 20% of the children present a fecal incontinence, and 14% a constipation in long-term studies. Bladder dysfunction and associated urological anomalies are also reported in these patients. All of that may facilitate the occurrence of febrile urinary tract infections (FUTI) in patients with HD. Unfortunately, few studies focused on this specific population.
The objective of this study was to find out whether children with HD are more prone to develop FUTIs than controls and which patient with HD are more at risk to develop UTIs.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Montpellier, Francia, 34295
- University hospital of Montpellier
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion criteria:
Patients :
- surgical treatment of an HD confirmed on histopathologic exam.
Controls :
- appendicetomy for acute appendicitis without history of HD, ano rectal malformation or any other colic disease
Exclusion criteria:
- patients with HD but not yet operated
- patient with a stoma at the time of the study
- patient with chronic intestinal pseudo obstruction without HD
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Retrospectivo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Compare the risk of febril urinary tract infection
Periodo de tiempo: Day 1
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Compare the risk of febril urinary tract infection between children with Hirschsprung disease and control Febrile urinary tract infection was defined as a positive urine examination with a single bacteria with more than 10.5 cfu/mL and more than 10.4 leukocytes/ml associated with fever above 38.5°C
and C-reactive protein (CRP) above 50 mg/
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Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Compare the age at the time of febrile urinary tract infection
Periodo de tiempo: Day 1
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Compare the age at the time of febrile urinary tract infection between children with Hirschsprung disease and control.
This event could occur sooner in children with Hirschsprung disease than controls.
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Day 1
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Febrile urinary tract infection risk factor
Periodo de tiempo: Day 1
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Febrile urinary tract infection risk factor for children with Hirschsprung disease based upon the form of the disease, kinf of surgery, functional results For each patient treated by Hirschsprung disease, surgical technique, the level of involvement and the functional outcome will be collected. The functional outcome was evaluated through the number of stool per day, the presence of soiling, the need of additional antegrade or retrograde colonic enema |
Day 1
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Enfermedades urológicas
- Heridas y Lesiones
- Atributos de la enfermedad
- Anomalías congénitas
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Cambios de temperatura corporal
- Trastornos de estrés por calor
- Anormalidades del Sistema Digestivo
- Megacolon
- Infecciones
- Enfermedades contagiosas
- Infecciones del tracto urinario
- Hipertermia
- Fiebre
- Enfermedad de Hirschsprung
Otros números de identificación del estudio
- RECHMPL21_0225
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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