Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial.
Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial.
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DOI：
10.1136/bmj-2021-065846
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发表时间：
2022-02-21
期刊：
影响因子：
--
通讯作者：
Harhangi BS
中科院分区：
文献类型：
--
作者：
Gadjradj PS;Rubinstein SM;Peul WC;Depauw PR;Vleggeert-Lankamp CL;Seiger A;van Susante JL;de Boer MR;van Tulder MW;Harhangi BS
目的：评价经皮穿孔内窥镜腰椎间盘摘除术(PTED)在减轻腰椎间盘突出症所致小腿疼痛方面是否不逊于传统的开腹腰椎间盘摘除术。非劣势设计的多中心随机对照试验。荷兰的四家医院。613名年龄在18-70岁之间的腰椎间盘突出症患者，有至少6周的放射性小腿疼痛。这项试验包括一组预先确定的接受PTED的患者，这些患者是在试验前没有做PTED的外科医生进行的学习曲线病例。经皮髓核摘除(n=179)与开放手术(n=309)比较。主要结果是自我报告的腿部疼痛在12个月时用0-100视觉模拟评分进行测量，假设非自卑差值为5.0。次要结果包括并发症、再次手术、用OSwestry残疾指数测量的自我报告的功能状态、背痛的视觉模拟评分、与健康相关的生活质量和自我感觉恢复。根据意向治疗原则对结果进行纵向分析，直到术后一年。初步分析中省略了属于PTED学习曲线的患者。在12个月时，随机接受PTED的患者腿部疼痛的视觉模拟评分(中位数7.0，四分位数范围1.0-30.0)显著低于随机接受开放微椎间盘切除术的患者(16.0，2.0-53.5)(组间差异7.1，95%可信区间2.8-11.3)。PTED组的出血量较少，住院时间较短，术后活动时间较开放组早。二次患者报告的结果，如奥斯维斯特里残疾指数，背痛视觉模拟评分，与健康相关的生活质量，以及自我感觉恢复，都同样支持PTED。在一年内，PTED组有9人(5%)进行了重复手术，而开放手术组有14人(6%)再次手术。按方案分析和敏感性分析，包括患者的学习曲线，结果与初步分析相似。在减轻小腿疼痛方面，经皮髓核摘除术并不逊色于开腹腰椎间盘摘除术。在自我报告的腿部疼痛、背部疼痛、功能状态、生活质量和康复方面，TATE的结果更有利。然而，这些差异很小，可能不会达到临床意义。在治疗坐骨神经痛方面，经皮显微髓核摘除术可被认为是一种有效的替代方法。NCT02602093临床试验网站NCT02602093。
To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. Multicentre randomised controlled trial with non-inferiority design. Four hospitals in the Netherlands. 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial. PTED (n=179) compared with open microdiscectomy (n=309). The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses. At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis. PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica. NCT02602093ClinicalTrials.gov NCT02602093.
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影响因子：
4.1
作者：
MAYER, HM;BROCK, M
通讯作者：
BROCK, M
影响因子：
3
作者：
Gadjradj PS;Harhangi BS;Amelink J;van Susante J;Kamper S;van Tulder M;Peul WC;Vleggeert-Lankamp C;Rubinstein SM
通讯作者：
Rubinstein SM
DOI：
10.2106/00004623-199907000-00008
发表时间：
1999-07-01
影响因子：
5.3
作者：
Hermantin, FU;Peters, T;Kambin, P
通讯作者：
Kambin, P
影响因子：
3
作者：
DeVine, John;Norvell, Daniel C.;Andersson, Gunnar
通讯作者：
Andersson, Gunnar
影响因子：
1.9
作者：
Gadjradj, Pravesh S.;Harhangi, Biswadjiet S.
通讯作者：
Harhangi, Biswadjiet S.