背景:腰椎间盘突出症是慢性下腰痛的主要原因之一。当保守方法失败时,手术仍然是选择的治疗方法。全内窥镜方法代表了成熟的显微外科技术的有希望的替代方案。然而,比较这些技术的高级证据仍然很少。
方法:将包括表现为腰椎间盘突出症的患者。干预组将获得全内镜下椎间盘减压术,而对照组则采用显微外科椎间盘减压术治疗。我们将应用一项全面的队列研究设计,涉及随机和前瞻性非随机研究小组。不同意随机化的患者将被分配到非随机化组。主要结果将是Oswestry残疾指数(ODI)。次要结果包括疼痛的视觉模拟量表(VAS)和SF-36健康问卷。此外,临床特征,包括住院时间,操作时间,并发症以及实验室标志物,如C反应蛋白,白细胞计数,和白细胞介素6将被确定和比较。
结论:本研究将通过评估全内窥镜技术与临床相关研究中腰椎间盘突出症的金标准的结果,为文献中现有的证据做出重要贡献。此外,研究设计使我们能够将不愿意随机分组的患者纳入前瞻性平行研究组,并评估随机分组对结局的影响,包括.该结果可能有助于改善腰椎间盘突出症患者的未来治疗方法。
背景:这项研究在德国临床试验注册(DRKS)中进行了前瞻性注册,德国世卫组织主要登记处,下注册号:DRKS00025786.2021年7月7日注册。
BACKGROUND: Lumbar disc herniation is one of the leading causes of chronic low back pain. Surgery remains the therapy of choice when conservative approaches fail. Full-endoscopic approaches represent a promising alternative to the well-established microsurgical technique. However, high-grade evidence comparing these techniques is still scarce.
METHODS: Patients presenting with lumbar disc herniation will be included. The intervention group will obtain full-endoscopic disc decompression, whereas the control group will be treated by microsurgical disc decompression. We will apply a comprehensive cohort
study design involving a randomized and a prospective non-randomized
study arm. Patients who do not consent to be randomized will be assigned to the non-randomized arm. The primary outcome will be the Oswestry Disability Index (ODI). Secondary outcomes involve the visual analog scale (VAS) of pain and the SF-36 health questionnaire. Furthermore, clinical characteristics including duration of hospital stay, operation time, and complications as well as laboratory markers, such as C-reactive protein, white blood cell counts, and interleukin 6 will be determined and compared.
CONCLUSIONS: This
study will significantly contribute to the current evidence available in the literature by evaluating the outcome of the full-endoscopic technique against the gold standard for lumbar disc herniation in a clinically relevant study setup. Additionally, the study design allows us to include patients not willing to be randomized in a prospective parallel
study arm and to evaluate the impact of randomization on outcomes and include. The results could help to improve the future therapy in patients suffering from lumbar disc herniation.
BACKGROUND: This
study was prospectively registered in The German Clinical Trials Register (DRKS), a German WHO primary registry, under the registration number: DRKS00025786. Registered on July 7, 2021.