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Delta大通道内镜与单侧双孔道内镜减压性椎板切除术治疗腰椎管狭窄症:一项前瞻性随机对照试验

Delta large-channel endoscopy versus unilateral biportal endoscopy decompressive laminectomy for lumbar spinal stenosis: a prospective randomized controlled trial.

作者信息

Wei Rushuo, Liu Weiqiang, Yu Mingdong, Zhu Yushan, Yao Ruzhan, Wang Bingwu, Li-Ling Jesse

机构信息

Department of Spinal Surgery, Weifang People's Hospital, Shandong Second Medical University, 151 Guangwen Street, Kuiwen District, Weifang, Shandong, 261000, China.

Digital Spine and Minimally Invasive Research Institute, Shandong Second Medical University, Weifang, Shandong, 261000, China.

出版信息

J Orthop Surg Res. 2025 Jan 4;20(1):10. doi: 10.1186/s13018-024-05409-0.

DOI:10.1186/s13018-024-05409-0
PMID:39754230
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11699819/
Abstract

BACKGROUND

Delta large-channel endoscopy and unilateral biportal endoscopy (UBE) are prominent minimally invasive techniques for treating lumbar spinal stenosis, known for minimal tissue damage, clear visualization, and quick recovery. However, rigorous controlled research comparing these procedures is scarce, necessitating further investigation into their respective complications and long-term effectiveness. This randomized controlled trial aims to compare their perioperative outcomes, focusing on postoperative recovery and complications over time.

METHODS

In total, 101 participants were randomly assigned to Delta large-channel endoscopy group (n = 50) or UBE group (n = 51). Primary measures were Oswestry Disability Index (ODI) scores and operation time. Secondary measures included VAS, EQ-5D, JOA scores, intraoperative blood loss, hospital stay duration, and costs. Perioperative complications such as dural tears, incision infections, hematomas, thrombosis, and reoperation rates were recorded.

RESULTS

The Delta group consistently showed lower mean ODI scores throughout the follow-up than UBE group, with significant differences at 2 weeks postoperative (P = 0.048), though they were not significant by 1 month (P = 0.124), 2 months (P = 0.821) and 3 months (P = 0.350). Operation times were shorter in the Delta group (P < 0.001). Hospitalization costs and intraoperative blood loss were slightly higher in the UBE group (P < 0.001). No significant differences were noted in the other secondary outcomes at various post-surgery intervals, such as VAS, EQ-5D, JOA scores, hospital stay duration and complications.

CONCLUSION

Both techniques are safe and effective when performed by experienced surgeons. Compared to UBE, Delta large-channel endoscopy can shorten surgery time and reduce blood loss, and more importantly, it promotes faster recovery of lumbar function in the early postoperative period.

RESEARCH REGISTRATION UNIQUE IDENTIFYING NUMBER (UIN): Name of the registry: Chinese Clinical Trial Registry chictr.org.cn. ( http://www.chictr.org.cn/index.aspx ). Unique Identifying number or registration ID: ChiCTR2300076237. Hyperlink to your specific registration (must be publicly accessible and will be checked): https://www.chictr.org.cn/showproj.html?proj=207 ,844.

摘要

背景

Delta 大通道内镜检查和单侧双通道内镜检查(UBE)是治疗腰椎管狭窄症的重要微创技术,以组织损伤小、视野清晰和恢复快而闻名。然而,比较这些手术的严格对照研究很少,有必要进一步研究它们各自的并发症和长期疗效。这项随机对照试验旨在比较它们的围手术期结果,重点关注术后恢复情况和不同时间的并发症。

方法

总共 101 名参与者被随机分配到 Delta 大通道内镜检查组(n = 50)或 UBE 检查组(n = 51)。主要指标是奥斯威斯功能障碍指数(ODI)评分和手术时间。次要指标包括视觉模拟评分法(VAS)、EQ-5D、日本骨科协会(JOA)评分、术中失血量、住院时间和费用。记录围手术期并发症,如硬脊膜撕裂、切口感染、血肿、血栓形成和再次手术率。

结果

在整个随访期间,Delta 组平均 ODI 评分始终低于 UBE 组,术后 2 周有显著差异(P = 0.048),但在 1 个月(P = 0.124)、2 个月(P = 0.821)和 3 个月(P = 0.350)时差异不显著。Delta 组手术时间更短(P < 0.001)。UBE 组的住院费用和术中失血量略高(P < 0.001)。在术后不同时间间隔的其他次要结果,如 VAS、EQ-5D、JOA 评分、住院时间和并发症方面,未发现显著差异。

结论

由经验丰富的外科医生进行操作时,这两种技术都是安全有效的。与 UBE 相比,Delta 大通道内镜检查可以缩短手术时间并减少失血量,更重要的是,它能促进术后早期腰椎功能更快恢复。

研究注册唯一识别号(UIN):注册机构名称:中国临床试验注册中心 chictr.org.cn。(http://www.chictr.org.cn/index.aspx)。唯一识别号或注册编号:ChiCTR2300076237。指向您特定注册的超链接(必须公开可访问并将进行检查):https://www.chictr.org.cn/showproj.html?proj=207,844。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/b14add723b0b/13018_2024_5409_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/a273aa1da844/13018_2024_5409_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/50032075e312/13018_2024_5409_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/76e92200315f/13018_2024_5409_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/b14add723b0b/13018_2024_5409_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/a273aa1da844/13018_2024_5409_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/50032075e312/13018_2024_5409_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/76e92200315f/13018_2024_5409_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3d87/11699819/b14add723b0b/13018_2024_5409_Fig4_HTML.jpg

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