Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis
Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon.
Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy.
The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Muenster, Alemania, 48149
- University of Muenster, Dept. of Medicine B
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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 over 18 years of age with
- known ulcerative colitis
- Indication for Standard Colonoscopy
- Informed Consent given by the patient
Exclusion Criteria:
- Patient has dysphagia
- Patient has congestive heart failure
- Patient has renal insufficiency
- Patient is known or is suspected to suffer from intestinal obstruction
- Patient has a cardiac pacemaker or other implanted electronical medical devices
- Patient is pregnant
- Patient has had prior abdominal surgery of the GI tract
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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UC
Patients with known ulcerative colitis
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PillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends.
It is 31.11
mm in size and takes pictures at a rate of 4 frames per second.
The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy.
Standard Colonoscopy: Pts.
undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)
Periodo de tiempo: 12 months
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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a) patient comfort b) detection of polyps c) differences in recognition of disease activity (physicians, nurses) d) differences in findings in the group of physicians (inter-observer differences)
Periodo de tiempo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tobias Meister, MD, University of Muenster, Dept. of Medicine B
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Med-B_CCE_vs_SC
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