DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY

Официальное название

COMPARISON OF DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY

Обзор

To compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.

Подробное описание

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.

Вмешательства

• Процедура Early Surgical Decompression
  it will be defined as the surgical decompression performed within 24 hours of injury. It will be performed among all the patients who presented within 24 hours of injury.
• Процедура Delayed Surgical Decompression
  It will be defined as the surgical decompression performed after 24 hours of spinal cord injury. It will be performed among all the patients who needed it due to medical optimization (such as hemodynamically unstable, shock, pulmonary contusions, cerebrovascular destabilization etc.) or those who will present after 24 hours of injury due to logistical delay.

Первичные конечные точки

• improvement in neurological impairment using ASIA Impairment Scale (AIS) [Срок оценки: 12 Weeks after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Пакистан · 1 центр

• Fauji Foundation Hospital, Rawalpindi — Rawalpindi

Идентификаторы

NCT: NCT07583836 · 999/RC/FFH/RWP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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