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GET-UP Trial 1-year results: long-term impact of an early mobilization protocol on functional performance after surgery for chronic subdural hematoma.
Journal of Neurosurgery ( IF 4.1 ) Pub Date : 2023-11-10 , DOI: 10.3171/2023.8.jns231509
Vasco Pinto 1, 2, 3 , Sérgio Alves Sousa 1 , Filipe Vaz da Silva 1 , Tiago Ribeiro da Costa 1 , Armindo Picão Fernandes 1 , Rodrigo Batata 1 , Carolina Noronha 1, 2, 3 , João Monteiro Silva 1 , Sónia Ferreira 1 , Salomé Sobral 1 , Célia Alves 1 , Rui Rangel 1 , Alfredo Calheiros 1, 2 ,
Affiliation  

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.

中文翻译:

GET-UP 试验 1 年结果:早期活动方案对慢性硬膜下血肿术后功能表现的长期影响。

慢性硬膜下血肿(cSDH)手术后活动时间的客观证据各不相同,并且神经外科中心之间的做法也存在很大差异。早期下床模式对慢性硬膜下血肿术后结果的影响: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。先前报道的临床出院时和术后 1 个月的结果表明,早期活动组发生医疗并发症的风险降低。在此,作者报告了一年随访的结果。方法 GET-UP 试验是一项前瞻性、随机、单中心、开放标签研究,具有意向治疗初步分析,旨在评估 cSDH 颅骨钻孔术后早期活动方案对医疗并发症和并发症发生率的影响。功能结果。2019 年 1 月至 2021 年 8 月期间,总共招募了 208 名患者,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(患者在术后 12 小时内开始抬高床头)患者保持躺卧状态 48 小时。1 年随访评估的结果包括通过格拉斯哥结果量表扩展 (GOSE) 测量的功能状态和血肿复发重复手术(手术复发)。结果共有203例患者完成了1年的随访:卧床休息组101例,早期活动组102例。两个管理组之间没有观察到显着的基线随机化前临床差异。术后 1 年,卧床休息组 59 名患者 (58.4%) 和早期活动组 78 名患者 (76.5%) 观察到良好的功能结果(定义为 GOSE 评分≥ 5)(p = 0.006)。卧床休息组有 25 名患者(24.8%)死亡,早期活动组有 16 名患者(15.7%)死亡(p = 0.108)。卧床休息组有 6 名患者 (5.9%) 出现手术复发,早期活动组有 7 名患者 (6.9%) 出现手术复发 (p = 0.788)。多变量分析显示早期活动与良好功能结果的增加之间存在独立关联(OR 2.006,95% CI 1.076-3.739,p = 0.028)。结论 GET-UP 试验是第一个评估动员策略对 cSDH 钻孔颅骨造口术后医疗并发症影响的随机临床试验。关于术后 1 年的功能结果,早期活动与功能结果的改善相关,且不增加手术复发。这些发现支持 cSDH 患者早期活动方案优于强制卧床休息策略。
更新日期:2023-11-10
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