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.

Authors

Vafa Rahimi-Movaghar, Research Centre for Neural Repair, Sina Trauma and Surgery Research Center, Tehran University Medical Sciences, Tehran, IranFollow
Soheil Saadat, Department of Epidemiology, Sina Trauma and Surgery Research Center, Tehran University Medical Sciences, Tehran, IranFollow
Alexander R Vaccaro, Department of Orthopaedics and Neurosurgery, Thomas Jefferson University and the Rothman Institute, Philadelphia, PA, USAFollow
Seyed Mohammad Ghodsi, Department of Neurosurgery, Sina Trauma and Surgery Research Center, Tehran University Medical Sciences, Tehran, IranFollow
Mohammad Samadian, Department of Neurosurgery, Shahid Beheshti University Medical Sciences, Tehran, IranFollow
Arya Sheykhmozaffari, Department of Neurosurgery, Zahedan University Medical Sciences, Zahedan, IranFollow
Seyed Mohammad Safdari, Department of Neurosurgery, Zahedan University Medical Sciences, Zahedan, IranFollow
Bahram Keshmirian, Department of Neurosurgery, Zahedan University Medical Sciences, Zahedan, IranFollow

Document Type

Article

Publication Date

1-1-2009

Comments

This article has been peer reviewed and is published in Trials Volume 10, 24 August 2009, Article number 77. The published version is available at DOI: 10.1186/1745-6215-10-77. Copyright © BioMed Central Ltd.

Abstract

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.

Recommended Citation

Rahimi-Movaghar, Vafa; Saadat, Soheil; Vaccaro, Alexander R; Ghodsi, Seyed Mohammad; Samadian, Mohammad; Sheykhmozaffari, Arya; Safdari, Seyed Mohammad; and Keshmirian, Bahram, "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." (2009). Department of Neurosurgery Faculty Papers. Paper 7.
https://jdc.jefferson.edu/neurosurgeryfp/7

PubMed ID

19703282