Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, South Korea.
Department of Orthopaedic Surgery, Chung-Ang University, College of Medicine, Seoul, South Korea.
Trials. 2022 Feb 22;23(1):172. doi: 10.1186/s13063-022-06094-2.
Biportal endoscopic surgery has recently been performed in lumbar discectomy, with advantages over conventional surgery, such as less skin scarring and muscle damage. However, the clinical results have not been established. Although previous studies reported no difference between the biportal endoscopic and microscopic discectomy clinical results, the evidence was weak. Therefore, this study aims to evaluate the efficacy and safety of the biportal endoscopic discectomy versus the microscopic discectomy.
This prospective multicenter randomized controlled equivalence trial is designed to compare the efficacy and safety outcomes of patients who underwent lumbar discectomy using biportal endoscopy or microscopy. We will include 100 participants (50 per group) with a lumbar herniated disc. The primary outcome will be the Oswestry Disability Index (ODI) score 12 months after surgery based on a modified intention-to-treat strategy. The secondary outcomes will include the visual analog scale score for low back and lower extremity radiating pain, the ODI score, the Euro-Qol-5-Dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scar, and surgery-related variables, such as postoperative drainage, operation time, admission duration, postoperative creatine kinase, and implementation status of conversion to open surgery. Radiographic outcomes will also be analyzed using magnetic resonance imaging (MRI) or computed tomography (CT) and simple radiographs. Safety will be assessed by evaluating all adverse and severe adverse events and surgery-related effects. The participants will be assessed by a blinded assessor before surgery (baseline) and 2 weeks and 3, 6, and 12 months after surgery.
This trial will be the first prospective, multicenter, randomized controlled trial to analyze the efficacy and safety of biportal endoscopic discectomy in lumbar herniated disc. This trial is designed for evaluating the equivalence of the results between biportal endoscopic and microscopic discectomy including adequate sample size, blinded analyses, and prospective registration to reduce bias. This trial will provide enough data on the effectiveness and safety of biportal endoscopic surgery and will be an important study that allows clear conclusions.
Clinical Research Information Service (cris.nih.go.kr.) ( KCT0006191 ). Registered on 27 March 2021.
经皮椎间孔镜下腰椎间盘切除术（PELD）已应用于腰椎间盘突出症的治疗，与传统手术相比，具有皮肤切口小、肌肉损伤小等优点。然而，其临床疗效仍有待进一步证实。虽然既往研究报道经皮椎间孔镜下腰椎间盘切除术与显微镜下腰椎间盘切除术的临床效果无差异，但证据仍较为薄弱。因此，本研究旨在评估经皮椎间孔镜下腰椎间盘切除术与显微镜下腰椎间盘切除术的疗效及安全性。
本研究为前瞻性多中心随机对照等效性试验，旨在比较经皮椎间孔镜下腰椎间盘切除术与显微镜下腰椎间盘切除术治疗腰椎间盘突出症的疗效和安全性。纳入 100 例（每组 50 例）腰椎间盘突出症患者，采用随机数字表法将患者分为经皮椎间孔镜下腰椎间盘切除术组和显微镜下腰椎间盘切除术组。主要结局指标为改良意向治疗分析下术后 12 个月时的 Oswestry 功能障碍指数（Oswestry Disability Index，ODI）评分。次要结局指标包括术后 2 周及 3、6、12 个月时的视觉模拟评分（visual analog scale，VAS）评分、ODI 评分、Euro-Qol-5-Dimensions 评分、手术满意度、行走时间、术后日常生活恢复时间、术后手术瘢痕、与手术相关的变量（如术后引流、手术时间、住院时间、术后肌酸激酶、中转开放手术情况）。影像学评估采用 MRI 或 CT 及普通 X 线。安全性评估包括所有不良事件和严重不良事件及手术相关并发症。由盲法评估者于术前（基线）及术后 2 周和 3、6、12 个月进行评估。
本研究为前瞻性、多中心、随机对照试验，旨在分析经皮椎间孔镜下腰椎间盘切除术治疗腰椎间盘突出症的疗效和安全性。本研究设计样本量充足、采用盲法分析、前瞻性注册，以减少偏倚，旨在比较经皮椎间孔镜下腰椎间盘切除术与显微镜下腰椎间盘切除术的等效性。本研究将为经皮椎间孔镜手术的有效性和安全性提供充分的数据，并为明确结论提供重要依据。
Clinical Research Information Service（cris.nih.go.kr）（KCT0006191）。注册日期：2021 年 3 月 27 日。
