经椎间孔入路与椎板间入路治疗腰椎间盘突出症的临床效果：一项临床研究方案
Clinical effects of transforaminal approach vs interlaminar approach in treating lumbar disc herniation: A clinical study protocol.
作者信息
Chen Wei, Zheng Yong, Liang Guiqing, Chen Guangfu, Hu Yabin
机构信息
Department of Spine Surgery, Fuzhou Second Hospital Affiliated to Xiamen University, Fujian.
Department of Bone Injury, Shaanxi Hospital of Traditional Chinese Medicine, Shaanxi.
出版信息
Medicine (Baltimore). 2020 Oct 30;99(44):e22701. doi: 10.1097/MD.0000000000022701.
BACKGROUND
Percutaneous endoscopic lumbar discectomy (PELD) has routinely performed in recent years for lumbar disc herniation because of the advances in technology of minimally invasive spine surgery. Two common operating routes for PELD have been introduced in the literature: transforaminal approach (TA) and interlaminar approach (IA). The purpose of our current retrospective clinical trial was to study whether the effect of IA-PELD is better than TA-PELD in the incidence of complications and clinical prognosis scores in the patients with L5-S1 lumbar disc herniation.
METHODS
Our present research was approved by the institutional review board in the Second Hospital of Nanjing. All the patients offered the informed consent. All the procedures containing human participants were conducted on the basis of the Helsinki Declaration. A retrospective analysis was implemented on 126 patients with L5-S1 disc herniated radiculopathy from March 2016 to March 2018, who were treated with the PELD utilizing the IA technique or the TA technique. Relevant data, such as the patients demographics, surgical duration, length of hospital stay, hospitalization expenses, complications were recorded. In our work, the outcomes of patients were determined at baseline, 6 months, 12 months, and 24 months after treatment. The measure of primary outcome was Oswestry Disability Index score. The other outcomes measured were Numeric Rating Scale pain scale, surgical duration, length of hospital stay, and complications. The software of SPSS Version 22.0 (IBM Corporation, Armonk, NY) was applied for the analysis of all the statistical data. When P value <.05, it was considered to be significant in statistics.
RESULTS
This protocol will provide a solid theoretical basis for exploring which PELD approach is better in treatment of lumbar disc herniation.
TRIAL REGISTRATION
This study protocol was registered in Research Registry (researchregistry5988).
背景
近年来，由于微创脊柱手术技术的进步，经皮内镜下腰椎间盘切除术（PELD）已常规用于治疗腰椎间盘突出症。文献中介绍了两种常见的PELD手术途径：经椎间孔入路（TA）和椎板间入路（IA）。我们当前这项回顾性临床试验的目的是研究在L5-S1腰椎间盘突出症患者中，IA-PELD在并发症发生率和临床预后评分方面的效果是否优于TA-PELD。
方法
我们目前的研究获得了南京医科大学第二附属医院机构审查委员会的批准。所有患者均签署了知情同意书。所有涉及人类受试者的程序均按照《赫尔辛基宣言》进行。对2016年3月至2018年3月期间采用IA技术或TA技术行PELD治疗的126例L5-S1椎间盘突出症伴神经根病患者进行回顾性分析。记录患者的人口统计学资料、手术时间、住院时间、住院费用、并发症等相关数据。在我们的研究中，在治疗后基线、6个月、12个月和24个月时确定患者的预后。主要预后指标为Oswestry功能障碍指数评分。测量的其他预后指标包括数字评分量表疼痛评分、手术时间、住院时间和并发症。使用SPSS 22.0版软件（IBM公司，纽约州阿蒙克）对所有统计数据进行分析。当P值<.05时，认为在统计学上具有显著性。
结果
本方案将为探索哪种PELD手术途径在治疗腰椎间盘突出症方面更好提供坚实的理论基础。
试验注册
本研究方案已在Research Registry（researchregistry5988）注册。
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