Is the Preoperative Preparation of Sickle Cell Patients Optimal: Assessment of Practices and Post-operative Complications
Is the Preoperative Preparation of Sickle Cell Patients Optimal: Retrospective Assessment of Practices and Post-operative Complications in a Cohort of Children Followed at Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF) and Who Have Been Managed According Local Guidelines Including Transfusion or Exchange Transfusion Before Surgery
Children with sickle cell disease systematically receive a transfusion 2 to 5 days before scheduled surgery (with the exception of minor surgeries) in order to avoid post-operative complications of which the vaso-occlusive crisis and acute thoracic syndrome are the most frequent.
This standardized preoperative protocol was established on the basis of the results of large-scale randomized studies, most of which date back over ten years, and which have demonstrated the beneficial effects of transfusion (or transfusion exchange) preoperatively. To date, several other more recent studies (but not controlled) have questioned this type of systematic management.
The purpose of this study is to review retrospectively data of sickle cell children who have undergone elective surgery at the Huderf in the last ten years and to identify the eventual complications encountered. The most common procedures in these patients are: tonsillectomy with or without associated adenoids, splenectomy and cholecystectomy.
General data on sickle cell disease (history, genotype, G6PD deficiency, biology and previous complications), pre-surgical preparation, surgery and post surgical management and complications will be collected and analyzed.
This retrospective analysis will allow an objective assessment of the current quality of care and will provide useful data to improve patient management.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brussles
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Brussels, Brussles, Bélgica, 1020
- Hopital Universitaire des Enfants Reine Fabiola
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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:
- Sickle cell disease with surgery during the 2010-2019 period
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To assess the overall incidence of vaso-occlusive-events 1 month post surgery
Periodo de tiempo: 1 month after surgery
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Vaso-occlusive-events will include Vaso Occlusive Crisis (acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)), acute chest syndrome (new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever) and hemoglobin < 6g/dl
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1 month after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery
Periodo de tiempo: 1 month after surgery
|
Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)
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1 month after surgery
|
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To assess the incidence of Vaso Occlusive Crisis 3 months post surgery
Periodo de tiempo: 3 months after surgery
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Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)
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3 months after surgery
|
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To assess the incidence of Vaso Occlusive Crisis 12 months post surgery
Periodo de tiempo: 12 months after surgery
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Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)
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12 months after surgery
|
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To assess the incidence of Acute Chest Syndrome 1 month post surgery
Periodo de tiempo: 1 month after surgery
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Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
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1 month after surgery
|
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To assess the incidence of Acute Chest Syndrome 3 months post surgery
Periodo de tiempo: 3 months after surgery
|
Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
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3 months after surgery
|
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To assess the incidence of Acute Chest Syndrome 12 months post surgery
Periodo de tiempo: 12 months after surgery
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Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
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12 months after surgery
|
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To assess the duration of hospitalization post-surgery
Periodo de tiempo: 1 month after surgery
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number of days between surgery and day of discharge
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1 month after surgery
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To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery
Periodo de tiempo: 1 month after surgery
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incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
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1 month after surgery
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To assess the incidence of RBC allo-immunization 3 months post surgery
Periodo de tiempo: 3 months after surgery
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incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
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3 months after surgery
|
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To assess the incidence of RBC allo-immunization 12 months post surgery
Periodo de tiempo: 12 months after surgery
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incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
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12 months after surgery
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To assess the number of RBC transfusion episodes 1 month post surgery
Periodo de tiempo: 1 month after surgery
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Number of RBC unit transfused
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1 month after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alina Ferster, MD, Queen Fabiola Children's University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P2020/Hemato/SCDPreop
Información sobre medicamentos y dispositivos, documentos del estudio
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