The efficacy of surgical decompression before 24 hours versus 24 to 72 hours in patients with spinal cord injury from T1 to L1 – with specific consideration on ethics: a randomized controlled trial
نویسندگان
چکیده
BACKGROUND There is no clear evidence that early decompression following spinal cord injury (SCI) improves neurologic outcome. Such information must be obtained from randomized controlled trials (RCTs). To date no large scale RCT has been performed evaluating the timing of surgical decompression in the setting of thoracolumbar spinal cord injury. A concern for many is the ethical dilemma that a delay in surgery may adversely effect neurologic recovery although this has never been conclusively proven. The purpose of this study is to compare the efficacy of early (before 24 hours) verse late (24-72 hours) surgical decompression in terms of neurological improvement in the setting of traumatic thoracolumbar spinal cord injury in a randomized format by independent, trained and blinded examiners. METHODS In this prospective, randomized clinical trial, 328 selected spinal cord injury patients with traumatic thoracolumbar spinal cord injury are to be randomly assigned to: 1) early surgery (before 24 hours); or 2) late surgery (24-72 hours). A rapid response team and set up is prepared to assist the early treatment for the early decompressive group. Supportive care, i.e. pressure support, immobilization, will be provided on admission to the late decompression group. Patients will be followed for at least 12 months posttrauma. DISCUSSION This study will hopefully assist in contributing to the question of the efficacy of the timing of surgery in traumatic thoracolumbar SCI. TRIAL REGISTRATION RCT registration number: ISRCTN61263382.
منابع مشابه
Early versus late surgical decompression for traumatic thoracic/thoracolumbar (T1-L1) spinal cord injured patients. Primary results of a randomized controlled trial at one year follow-up.
OBJECTIVE To assess the efficacy of surgical decompression <24 (early) versus 24-72 hours (late) in thoracic/thoracolumbar traumatic spinal cord injury (TSCI). METHODS A randomized controlled trial (RCT) of 35 T1-L1 TSCI patients including early (n=16) and late (n=19) surgical decompression was conducted in the neurosurgery department of Shahid Rajaee Hospital from September 2010. Pre- and po...
متن کاملPrimary report for a randomized controlled trial of traumatic spinal cord injured patients from T1 to L1 - description of the surgical decompression in two groups of before 24 hours and 24 to 72 hours
Background: There is no clear evidence that early decompression following spinal cord injury (SCI) improves neurologic outcome. In this primary report for prospective, randomized clinical trial, 35 selected spinal cord injured patients with traumatic thoracolumbar spinal cord injury were randomly assigned to early surgery (before 24 hours); and late surgery (24–72 hours). Methods: Seventeen pat...
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STUDY DESIGN A prospective analysis evaluating neurologic outcome after early versus late surgery for cervical spinal cord trauma. OBJECTIVES The study was conducted to determine whether neurologic and functional outcome is improved in traumatic cervical spinal cord-injured patients (C3-T1, American Spinal Injury Association grades A-D) who had early surgery (<72 hours after spinal cord injur...
متن کاملEarly versus late spinal decompression surgery in treatment of traumatic spinal cord injuries; a systematic review and meta-analysis
INTRODUCTION Despite the vast number of surveys, no consensus has been reached on the optimum timing of spinal decompression surgery. This systematic review and meta-analysis aimed to compare the effects of early and latespinal decompression surgery on neurologic improvement and post-surgical complications in patients with traumatic spinal cord injuries. METHODS Two independent reviewers carr...
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BACKGROUND The optimal management of acute cervical spinal cord injury (SCI) associated with preexisting canal stenosis remains to be established. The objective of this study is to examine whether early surgical decompression (within 24 hours after admission) would result in greater improvement in motor function compared with delayed surgery (later than two weeks) in cervical SCI patients prese...
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ورودعنوان ژورنال:
- Trials
دوره 10 شماره
صفحات -
تاریخ انتشار 2009