Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China
BMJ Open. 2019 Dec 30;9(12):e033888. doi: 10.1136/bmjopen-2019-033888.
For sciatica caused by lumbar disc herniation (LDH), the standard surgical technique is conventional microdiscectomy. In recent years, minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM)) have gained increasing interest. PTED and PMTM are considered alternative minimally invasive techniques for the treatment of LDH. Due to insufficient evidence, the differences in efficacy between PTED and PMTM have been debated. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the efficacy and cost-effectiveness of PTED versus PMTM for the treatment of LDH.
A total of 280 patients (18-70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited. Patients must have an indication for surgery based on MRI demonstrating LDH with nerve root compression. Patients will be randomised to PTED or PMTM treatment. The primary outcome is Oswestry Disability Index scores. Secondary outcomes include Visual Analogue Scale scores, Short Form 36 health survey scores, physical examination, length of hospital stay, costs and complications. Outcomes will be measured the day following surgery, at 1 week, and at 1, 3, 6, 12 and 24 months after surgical treatment. Physical examination will be conducted at 1 week, 1 month and 12 months after surgery. The non-inferiority margin for the primary outcome is 5.
Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2018YF010-02). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences.
ChiCTR1800015727; Pre-results.
对于腰椎间盘突出症（LDH）引起的坐骨神经痛，标准的手术技术是传统的微创手术。近年来，微创技术（如经皮椎间孔内窥镜椎间盘切除术（PTED）、脊柱旁小通道显微镜下椎间盘切除术（PMTM））越来越受到关注。PTED 和 PMTM 被认为是治疗 LDH 的替代微创技术。由于证据不足，PTED 和 PMTM 的疗效差异一直存在争议。一项实用的、多中心的、非劣效性、随机对照试验已被设计用于确定 PTED 与 PMTM 治疗 LDH 的疗效和成本效益。
共招募 280 名（18-70 岁）出现明显坐骨神经痛症状且经 3 个月保守治疗后无效的患者。患者必须有 MRI 显示 LDH 合并神经根受压的手术指征。患者将被随机分配至 PTED 或 PMTM 治疗。主要结局是 Oswestry 残疾指数评分。次要结局包括视觉模拟量表评分、SF-36 健康调查评分、体格检查、住院时间、成本和并发症。术后第 1 天、第 1 周、第 1、3、6、12 和 24 个月时进行测量。术后第 1 周、第 1 个月和第 12 个月进行体格检查。主要结局的非劣效性边界为 5。
中国福建医科大学附属协和医院伦理委员会已批准本研究（2018YF010-02）。研究结果将发表在国际同行评议的科学期刊上，并通过科学会议的演讲进行传播。
ChiCTR1800015727；预结果。
