Department of Neurosurgery, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Department of Neurosurgery, Kyung Hee University Medical Center, Seoul, Republic of Korea.
J Orthop Surg Res. 2022 Mar 28;17(1):187. doi: 10.1186/s13018-022-03052-1.
Advances in minimally invasive surgery have expanded the indications for interlaminar full-endoscopic discectomy. Although the clinical outcomes for this approach may be equivalent to those of conventional microscopic discectomy, the supporting evidence is still based on small, single-center, prospective, and retrospective studies. Therefore, a multicenter randomized controlled trial is warranted.
This will be a prospective, multicenter, randomized controlled trial comparing the efficacy and safety of interlaminar full-endoscopic discectomy to those of conventional microscopic discectomy. The trial will enroll 100 participants with a lumbar disc herniation, 50 in each group. The primary outcome will be the Oswestry Disability Index (ODI) score at 12 months post-surgery. Secondary outcomes will be back and leg pain (visual analog scale); the ODI; the EuroQol-5-dimension score; patient satisfaction; and walking distance/time and time to return to daily activities post-surgery. Surgical outcomes will include postoperative drainage, operative time, duration of hospital stay, postoperative creatine kinase level as an indicator of muscle injury, and postoperative scarring. Postoperative magnetic resonance imaging, computed tomography, and simple radiography will be performed to evaluate radiographic outcomes between the two surgical approaches. Surgery-related complications and adverse effects will be evaluated as safety outcomes. A single assessor at each participating hospital, blinded to group allocation, will assess the enrolled participants at baseline, at 2 weeks, and at 3, 6, and 12 months postoperatively.
This trial is designed to determine whether interlaminar full-endoscopic discectomy is clinically comparable to microscopic discectomy to treat lumbar disc herniations. All efforts will be made to reduce bias, including adequate sample size, blinded analyses, and multicenter prospective registration. The outcomes will inform practice, providing the evidence needed for using interlaminar full-endoscopic over microscopic discectomy by confirming the potential of this technique to improve patient satisfaction and clinical outcomes.
Clinical Research Information Service; cris.nih.go.kr. (KCT0006277); protocol version (v1, June 8, 2021).
微创技术的进步扩大了经椎间孔全内镜下椎间盘切除术的适应证。虽然这种方法的临床效果可能与传统显微镜下椎间盘切除术相当，但支持证据仍然基于小型、单中心、前瞻性和回顾性研究。因此，有必要进行多中心随机对照试验。
这将是一项前瞻性、多中心、随机对照试验，比较经椎间孔全内镜下椎间盘切除术与传统显微镜下椎间盘切除术的疗效和安全性。试验将纳入 100 例腰椎间盘突出症患者，每组 50 例。主要结局指标为术后 12 个月的 Oswestry 功能障碍指数（ODI）评分。次要结局指标为腰背腿痛（视觉模拟评分）、ODI、EuroQol-5 维度评分、患者满意度、术后步行距离/时间和恢复日常活动时间。手术结果包括术后引流、手术时间、住院时间、术后肌酸激酶水平作为肌肉损伤指标、术后瘢痕。术后磁共振成像、计算机断层扫描和简单的放射照相将用于评估两种手术方法的影像学结果。手术相关并发症和不良反应将作为安全性结局进行评估。每个参与医院的单一评估者将对纳入的参与者进行基线、术后 2 周以及术后 3、6 和 12 个月的评估，对分组情况不知情。
本试验旨在确定经椎间孔全内镜下椎间盘切除术与显微镜下椎间盘切除术治疗腰椎间盘突出症是否具有临床可比性。将尽一切努力减少偏倚，包括足够的样本量、盲法分析和多中心前瞻性注册。这些结果将为实践提供信息，通过确认该技术改善患者满意度和临床结果的潜力，为使用经椎间孔全内镜下椎间盘切除术而不是显微镜下椎间盘切除术提供所需的证据。
临床研究信息服务；cris.nih.go.kr（KCT0006277）；方案版本（v1，2021 年 6 月 8 日）。
