Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands.
Department of Neurosurgery, Leiden University Medical Centre, Leiden, The Netherlands.
BMJ Open. 2017 Dec 21;7(12):e018230. doi: 10.1136/bmjopen-2017-018230.
Lumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the treatment of lumbar disc herniation.
In total, 682 patients between 18 and 70 years of age with >10 weeks of radiating pain or with >6 weeks of excessive radiating pain are to be recruited from participating centres. Patients must have an indication for surgery based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Patients are to be randomised to PTED or open microdiscectomy. The primary outcome is self-reported leg pain measured by the 0-100 mm Visual Analogue Scale. Secondary outcomes include self-reported health and functional status, back pain, self-perceived recovery and a physical examination. Outcomes will be measured the day following surgery, at 2, 4 and 6 weeks, and at 3, 6, 9, 12 and 24 months. Physical examination will be performed at 6 weeks, and 3 and 12 months. An economic evaluation will be performed from a societal perspective and cost questionnaires will be used (eg, EQ-5D-5L). The data will be analysed longitudinally; the non-inferiority margin for the primary outcome is 5. Bootstrapping techniques will be used for the economic evaluation.
This study has received approval of the Medical Ethical Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The results will be published in an international peer-reviewed scientific journal.
NCT02602093; Pre-results, recruiting stage.
腰骶神经根综合征通常由椎间盘突出引起。去除椎间盘突出的标准手术技术是开放式显微椎间盘切除术。另一种技术是经皮椎间孔内窥镜椎间盘切除术（PTED），它的侵入性更小。在荷兰，PTED 目前不被认为是标准治疗方法，因此不在公共医疗保险范围内报销。本研究设计了一项实用的、多中心的、非劣效性、随机对照试验，以确定 PTED 与开放式显微椎间盘切除术治疗腰椎间盘突出症的疗效和成本效益。
总计将从参与中心招募 682 名年龄在 18 至 70 岁之间、放射痛持续>10 周或过度放射痛持续>6 周的患者。患者必须有 MRI 显示神经根受压的手术指征，MRI 显示由腰椎间盘突出引起的神经根受压。患者将被随机分配到 PTED 或开放式显微椎间盘切除术组。主要结局是通过 0-100mm 视觉模拟量表（VAS）自我报告的腿部疼痛。次要结局包括自我报告的健康和功能状况、腰痛、自我感知的恢复情况和体格检查。结果将在手术后的第 1 天、第 2、4 和 6 周，以及第 3、6、9、12 和 24 个月进行测量。体格检查将在第 6 周和第 3、12 个月进行。将从社会角度进行经济评估，并使用成本调查问卷（例如 EQ-5D-5L）。数据将进行纵向分析；主要结局的非劣效性边界为 5。将使用 bootstrap 技术进行经济评估。
本研究已获得阿姆斯特丹 VU 医学中心医学伦理委员会的批准：NL50951.029.14。研究结果将发表在国际同行评议的科学期刊上。
NCT02602093；预结果，招募阶段。
