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GET-UP 试验 1 年结果:慢性硬脑膜下血肿手术后早期活动方案对功能表现的长期影响。

GET-UP Trial 1-year results: long-term impact of an early mobilization protocol on functional performance after surgery for chronic subdural hematoma.

机构信息

1Department of Neurosurgery, University Hospital Center of Santo António, Porto.

2Department of Anatomy, UMIB-Unit for Multidisciplinary Research in Biomedicine, ICBAS-School of Medicine and Biomedical Sciences, University of Porto; and.

出版信息

J Neurosurg. 2023 Nov 10;140(5):1434-1441. doi: 10.3171/2023.8.JNS231509. Print 2024 May 1.

Abstract

OBJECTIVE

Evidence on timing for mobilization after chronic subdural hematoma (cSDH) surgery is heterogeneous, and practices differ considerably among neurosurgical centers. The Impact of an Early Out-of-Bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial (GET-UP Trial) is a randomized clinical trial comparing a postoperative early mobilization protocol to bed rest. Previously reported results at clinical discharge and 1 month after surgery indicated a decreased risk of medical complications in the early mobilization group. Herein, the authors report outcomes at the 1-year follow-up.

METHODS

The GET-UP Trial is a prospective, randomized, unicentric, open-label study with an intention-to-treat primary analysis designed to evaluate the impact of an early mobilization protocol after burr hole craniostomy for cSDH on the occurrence of medical complications and functional outcomes. Between January 2019 and August 2021, a total of 208 patients were recruited and randomized to either an early mobilization group, in which patients began elevation of the head of the bed within the first 12 hours after surgery, or to a bed rest group, in which patients remained recumbent for 48 hours. Outcomes assessed at the 1-year follow-up included functional status as measured by the Glasgow Outcome Scale-Extended (GOSE) and repeat surgery for hematoma recurrence (surgical recurrence).

RESULTS

A total of 203 patients completed 1 year of follow-up: 101 in the bed rest group and 102 in the early mobilization group. No significant baseline pre-randomization clinical differences were observed between the two management groups. At 1 year after surgery, a favorable functional outcome, defined as a GOSE score ≥ 5, was observed in 59 patients (58.4%) in the bed rest group and 78 (76.5%) in the early mobilization group (p = 0.006). Death occurred in 25 patients (24.8%) in the bed rest group and 16 (15.7%) in the early mobilization group (p = 0.108). Surgical recurrence was noted in 6 patients (5.9%) in the bed rest group and 7 (6.9%) in the early mobilization group (p = 0.788). Multivariate analysis showed an independent association between early mobilization and an increase in favorable functional outcomes (OR 2.006, 95% CI 1.076-3.739, p = 0.028).

CONCLUSIONS

The GET-UP Trial is the first randomized clinical trial assessing the impact of mobilization strategies on medical complications after burr hole craniostomy for cSDH. Regarding functional results 1 year after surgery, early mobilization was associated with an improvement in functional outcomes without an increase in surgical recurrence. These findings support the preference for an early mobilization protocol in cSDH patients over mandatory bed rest strategies.

摘要

目的

慢性硬脑膜下血肿(cSDH)手术后的活动时机的证据存在差异,神经外科中心之间的做法也有很大差异。术后早期下床对慢性硬脑膜下血肿术后结局的影响:GET-UP 随机前瞻性试验(GET-UP 试验)是一项比较术后早期活动方案与卧床休息的随机临床试验。先前报告的临床出院和术后 1 个月的结果表明,早期活动组的医疗并发症风险降低。在此,作者报告了 1 年随访的结果。

方法

GET-UP 试验是一项前瞻性、随机、单中心、开放标签的研究,采用意向治疗主要分析,旨在评估颅骨钻孔术治疗 cSDH 后早期活动方案对医疗并发症和功能结局的影响。2019 年 1 月至 2021 年 8 月期间,共招募了 208 例患者,并随机分为早期活动组,患者在术后 12 小时内开始抬高床头;或卧床休息组,患者保持卧床 48 小时。1 年随访时评估的结局包括功能状态,采用格拉斯哥结局量表扩展版(GOSE)评估;以及血肿复发(手术复发)的再次手术。

结果

共有 203 例患者完成了 1 年随访:卧床休息组 101 例,早期活动组 102 例。两组管理组在随机分组前的基线临床差异无统计学意义。术后 1 年,卧床休息组 59 例(58.4%)和早期活动组 78 例(76.5%)的功能结局良好(GOSE 评分≥5),差异有统计学意义(p=0.006)。卧床休息组死亡 25 例(24.8%),早期活动组死亡 16 例(15.7%),差异无统计学意义(p=0.108)。卧床休息组手术复发 6 例(5.9%),早期活动组手术复发 7 例(6.9%),差异无统计学意义(p=0.788)。多变量分析显示,早期活动与功能结局良好的独立关联(OR 2.006,95%CI 1.076-3.739,p=0.028)。

结论

GET-UP 试验是评估颅骨钻孔术治疗 cSDH 后活动策略对医疗并发症影响的第一项随机临床试验。就术后 1 年的功能结果而言,早期活动与功能结局改善相关,而手术复发无增加。这些发现支持 cSDH 患者采用早期活动方案而不是强制性卧床休息策略。

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