- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02627781
Diagnostic Algorithm for Appendizitis (DIALAPP) (DIALAPP)
Evaluation of Diagnostic Algorithm for Suspected Acute Appendicitis
The diagnosis of acute appendicitis remains a challenge in daily clinical practice. The high incidence of appendicitis drives the need to reduce morbidity and unnecessary costs due to negative appendectomies. The aim of the present observation study is to evaluate a diagnostic and therapeutic algorithm for suspected acute appendicitis.
The investigators believe that this diagnostic algorithm helps to simultaneously avoid unnecessary operations, costs and radiation exposure.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This prospective observation study will be performed in the university hospital Frankfurt with a 24-h emergency service, with surgery and radiology readily available. The data will be compiled on patients older than 18 years who will be admitted to the emergency unit with suspected appendicitis.
During the study period, the clinical workflow is standardized. In all cases a resident of surgery and/or consultant surgeon clinically evaluate and perform an ultrasound scan on all patients with suspected appendicitis. With the use of clinical and laboratory results the physician (surgeon) will calculate the Alvarado Score and depending on the result the next diagnostic steps or the treatment will be chosen. Additionally, the department of gynecology of the university hospital routinely evaluate all women of childbearing age. Upon other terms following variables will be collected: age, gender, white blood cells (WBC), C-reactive protein (CRP), Alvarado Score, visuell pain scale, CT scan results, pathologic findings, time between admission and operation, operation procedure, treatment and diagnosis of patients without operation, length of hospital stay, and 30-day complication rate. Furthermore, there will be a follow-up of all patients (with and without operation) after 30 days and 6 months.
The investigators assume that the use of a diagnostic and therapeutic algorithm reduces unnecessary negative appendectomies and optimizes the duration of the hospital stay and the costs.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Frankfurt, Alemania, 60590
- Reclutamiento
- Goethe University
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Contacto:
- Alexander Reinisch, MD
- Número de teléfono: +4963016502
- Correo electrónico: alexander.reinisch@kgu.de
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Contacto:
- Juliane Liese, MD
- Número de teléfono: +4963015251
- Correo electrónico: juliane.liese@kgu.de
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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:
- complete evaluation, examination and diagnostic pathways of the patients with suspected appendicitis in our University Hospital
Exclusion Criteria:
- appendectomy during other operations
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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suspected appendicitis
This group includes all patients with suspected appendicitis, who are admitted to our University Hospital.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Evaluation of the negative appendectomy rate
Periodo de tiempo: 6 months
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In this part of the study, the negative appendectomy rate will be determined.
A negative appendectomy is characterized by normal findings in the pathological examination and therefore constitutes a medically unnecessary appendectomy.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The influence of computed tomography for the diagnosis of acute appendicitis
Periodo de tiempo: 30 days
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In this part of the study the investigators evaluate the careful and cost-effective integration of computed tomography in the clinical pathway.
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30 days
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Incidence of readmission to hospital
Periodo de tiempo: 6 months
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In this part of the study the readmission rate to hospital will be evaluated because of postoperative complications, infections and continuous abdominal pain will be included.
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6 months
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Evaluation of postoperative complications
Periodo de tiempo: 6 months
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In all patients, who received an appendectomy the postoperative complication rate will be recorded.
In statistical analysis factors, which are associated with complications will be analyzed.
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Juliane Liese, MD, General and Visceral Surgery
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- 268/15
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