- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07583836
DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
COMPARISON OF DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Despite the increasing advocacy for early surgery, significant variability persists in clinical practice. This inconsistency stems from conflicting evidence in the literature, with some studies reporting substantial neurological benefits from early intervention, while others find no significant difference compared to delayed surgery. Similarly, in our institute, both early and delayed decompressions are in practice, whichever considered suitable by the experts. But no study has done to date that compare the outcome of both techniques. Given these gaps, there is a pressing need for a comprehensive evaluation of the existing evidence to determine the optimal timing of surgical intervention for acute traumatic SCI especially among our local population where past evidence is scarce. So, this study seeks to contribute to this critical discourse by systematically evaluating the impact of early versus delayed surgical decompression on clinical outcomes in our local population. The study would not only add evidence to the global and local data but would also help the surgeons to choose the better technique in future as the technique with better outcome would be preferred in future among all the local patients who will present to our hospital with acute SCI. Adopting the treatment strategy with better outcome would also help to reduce the overall morbidity associated with a cute SCI in our local population.
Finally objectives are , to compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr. Salman Tahir, MBBS
- Número de teléfono: +92 322 6192355
- Correo electrónico: ffh.rawalpindi@fauji.org.pk
Ubicaciones de estudio
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Rawalpindi, Pakistán
- Reclutamiento
- Fauji Foundation Hospital, Rawalpindi
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Contacto:
- Salman Dr, MBBS
- Número de teléfono: +92 322 6192355
- Correo electrónico: xalmantahir@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients presenting with spinal cord injury (both cervical and thoracic) as per described in the operational definition
- Age from 18-60 years
- Both male and female patients
Exclusion Criteria:
- Patients with penetrating spinal injuries such as gunshot/stab wounds
- Patients with pre-existing neurological conditions like myelopathy etc.
- Patients with any kind of malignancy
- Patients having CSF infection etc.
- Patients who are not fit for general anesthesia (i.e. ASA Grade >2 Annexure-B)
- Diagnosis of subclinical or clinical polyneuropathy
- Non-traumatic or pathological fractures or cord compression
- Inability to cooperate with preoperative physical examination because of cognitive impairment
- Patients with previous spinal column or SCI.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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improvement in neurological impairment using ASIA Impairment Scale (AIS)
Periodo de tiempo: 12 Weeks after surgery
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Treatment outcomes will be measured 12 weeks after early or delayed surgical decompression among all the patients who underwent spinal cord injury in terms of improvement in neurological impairment using ASIA Impairment Scale (AIS) attached as annexure-C.
Outcome will be labelled as good if shows improvement for at least two AIS grades.
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12 Weeks after surgery
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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 (Estimado)
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
Otros números de identificación del estudio
- 999/RC/FFH/RWP
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