Suppr超能文献

管状切除术与传统微创手术治疗腰椎间盘突出症的比较:一项随机对照试验的长期结果。

Tubular discectomy versus conventional microdiscectomy for the treatment of lumbar disc herniation: long-term results of a randomised controlled trial.

机构信息

Department of Neurosurgery, The Hague Medical Center, The Hague, The Netherlands.

Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands.

出版信息

J Neurol Neurosurg Psychiatry. 2017 Dec;88(12):1008-1016. doi: 10.1136/jnnp-2016-315306. Epub 2017 May 26.

Abstract

BACKGROUND

The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up. Studies with long-term follow-up are required to determine if clinical outcomes are sustained and to assess specific long-term outcomes such as reoperation rate and iatrogenic low back pain due to impaired spinal integrity. The aim of this study is to evaluate the 5-year results of tubular discectomy compared with conventional microdiscectomy.

METHODS

The study was designed as a double-blind randomised controlled trial. 325 patients with a symptomatic lumbar disc herniation were randomly allocated to tubular discectomy (166 patients) or conventional microdiscectomy (159 patients). Repeated standardised follow-up measurements were performed at 2, 4, 6, 8, 12, 26, 38, 52, 78, 104, 156, 208 and 260 weeks after randomisation. Main outcomes are the Roland-Morris Disability Questionnaire for Sciatica (RDQ), Visual Analogue Scale for leg pain and low back pain, self-perceived recovery and reoperation incidence.

RESULTS

There was no clinically significant difference between tubular discectomy and conventional microdiscectomy regarding the main clinical outcomes at any time point during the 5 years of follow-up. RDQ scores at 5 years were 4.3 (95% CI 3.3 to 5.2) in the tubular discectomy group and 3.4 (95% CI 2.4 to 4.5) in the conventional microdiscectomy group. The mean difference of 0.9 (95% CI -0.6 to 2.2) was not significant. Mean differences for leg pain and back pain were 0.2 (95% CI -5.5 to 6.0) and 0.4 (95% CI -5.9 to 6.7), respectively. 77% of patients allocated to conventional discectomy reported complete or near-complete recovery of symptoms compared with 74% of patients allocated to tubular discectomy (p=0.79). The reoperation rate was 18% in the tubular discectomy group and 13% in the conventional discectomy group (p=0.29).

CONCLUSIONS

Long-term functional and clinical outcome did not differ between patients allocated to tubular discectomy and conventional microdiscectomy. Primary and secondary outcome measures did not support the hypothesised advantages of tubular discectomy over conventional microdiscectomy.

TRIAL REGISTRATION NUMBER

ISRCTN51857546.

摘要

背景

治疗腰椎间盘突出症的参考手术是开放式微创手术。管状牵开器的微创椎间盘切除术被假设会造成较少的组织损伤,导致更少的失血、术后疼痛减轻和更快的恢复。我们之前报告了我们的 1 年和 2 年结果,发现管状椎间盘切除术与开放式微创手术相比没有更好的结果。到目前为止,还没有关于管状椎间盘切除术的研究报告超过 2 年随访的结果。需要进行长期随访的研究来确定临床结果是否持续,并评估特定的长期结果,如由于脊柱完整性受损而导致的再手术率和医源性腰痛。本研究的目的是评估管状椎间盘切除术与传统微创手术相比的 5 年结果。

方法

该研究设计为双盲随机对照试验。325 名患有症状性腰椎间盘突出症的患者被随机分配到管状椎间盘切除术(166 例)或传统微创手术(159 例)组。在随机分组后 2、4、6、8、12、26、38、52、78、104、156、208 和 260 周进行重复的标准化随访测量。主要结局是罗伦兹-莫里斯残疾问卷(用于评估坐骨神经痛)(RDQ)、腿部疼痛和腰痛的视觉模拟量表、自我感知的恢复情况和再手术发生率。

结果

在 5 年的随访期间,管状椎间盘切除术与传统微创手术在任何时间点的主要临床结局均无临床显著差异。管状椎间盘切除术组的 RDQ 评分在 5 年后为 4.3(95%置信区间 3.3 至 5.2),传统微创手术组为 3.4(95%置信区间 2.4 至 4.5)。0.9 的平均差异(95%置信区间 -0.6 至 2.2)无显著意义。腿部疼痛和腰痛的平均差异分别为 0.2(95%置信区间 -5.5 至 6.0)和 0.4(95%置信区间 -5.9 至 6.7)。与被分配到常规椎间盘切除术的患者相比,77%被分配到常规椎间盘切除术的患者报告症状完全或几乎完全恢复,而 74%被分配到管状椎间盘切除术的患者报告症状完全或几乎完全恢复(p=0.79)。管状椎间盘切除术组的再手术率为 18%,常规椎间盘切除术组为 13%(p=0.29)。

结论

接受管状椎间盘切除术和传统微创手术的患者的长期功能和临床结局没有差异。主要和次要结局指标均不支持管状椎间盘切除术优于传统微创手术的假设优势。

试验注册号

ISRCTN51857546。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验