1Department of Neurosurgery, Centro Hospitalar Universitário de Santo António, Porto, Portugal.
3ITR-Laboratory for Integrative and Translational Research in Population Health, Porto, Portugal.
J Neurosurg. 2023 Mar 17;139(3):854-863. doi: 10.3171/2023.2.JNS222262. Print 2023 Sep 1.
Timing of mobilization after chronic subdural hematoma (cSDH) surgery is highly heterogeneous among neurosurgical centers. Past studies have suggested that early mobilization may reduce medical complications without increasing recurrence, but evidence remains scarce. The purpose of this study was to compare an early mobilization protocol with a 48-hour bed rest practice, with a focus on the occurrence of medical complications.
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. A total of 208 patients were recruited and randomly assigned to either an early mobilization group where they began head-of-bed elevation within the first 12 hours after surgery and proceeded to sedestation, orthostatism, and/or walking as rapidly as tolerated, or to a bed rest group where they remained recumbent with a head-of-bed angle inferior to 30° for 48 hours after surgery. The primary outcome was the occurrence of a medical complication (defined as either an infection, seizure, or thrombotic event) after surgery and until clinical discharge. Secondary outcomes included length of stay measured from randomization to clinical discharge, surgical hematoma recurrence at clinical discharge and 1 month after surgery, and Glasgow Outcome Scale-Extended (GOSE) assessment at clinical discharge and 1 month after surgery.
A total of 104 patients were randomly assigned to each group. No significant baseline clinical differences were observed before randomization. The primary outcome occurred in 36 (34.6%) patients included in the bed rest group and 20 (19.2%) in the early mobilization group (p = 0.012). At 1 month after surgery, a favorable functional outcome (defined as GOSE score ≥ 5) was observed in 75 (72.1%) patients in the bed rest group and 85 (81.7%) in the early mobilization group (p = 0.100). Surgical recurrence occurred in 5 (4.8%) patients in the bed rest group and 8 (7.7%) in the early mobilization group (p = 0.390).
The GET-UP Trial is the first randomized clinical trial to assess the impact of mobilization strategies on medical complications after burr hole craniostomy for cSDH. Early mobilization was associated with a reduction in medical complications without a significant effect on surgical recurrence, compared with a 48-hour bed rest protocol.
慢性硬脑膜下血肿(cSDH)手术后的活动时机在神经外科中心之间存在很大差异。过去的研究表明,早期活动可能会减少医疗并发症而不会增加复发,但证据仍然很少。本研究的目的是比较早期活动方案与 48 小时卧床休息实践,重点是医疗并发症的发生。
GET-UP 试验是一项前瞻性、随机、单中心、开放标签的研究,其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发生和功能结局的影响。共招募了 208 例患者,并随机分为早期活动组,他们在手术后 12 小时内开始床头抬高,并尽快进行镇静、直立和/或行走,或卧床休息组,他们在手术后 48 小时内保持床头角度小于 30°。主要结局是手术后直至临床出院期间发生医疗并发症(定义为感染、癫痫发作或血栓事件)。次要结局包括从随机分组到临床出院的住院时间、临床出院和手术后 1 个月时的手术血肿复发、临床出院和手术后 1 个月时的格拉斯哥结局量表扩展(GOSE)评估。
共有 104 例患者随机分为每组。在随机分组前,两组患者的基线临床差异无统计学意义。卧床休息组 36 例(34.6%)和早期活动组 20 例(19.2%)患者发生主要结局(p=0.012)。术后 1 个月,卧床休息组 75 例(72.1%)和早期活动组 85 例(81.7%)患者的功能结局良好(GOSE 评分≥5)(p=0.100)。卧床休息组 5 例(4.8%)和早期活动组 8 例(7.7%)患者发生手术复发(p=0.390)。
GET-UP 试验是第一项评估颅骨钻孔术治疗 cSDH 后活动策略对医疗并发症影响的随机临床试验。与 48 小时卧床休息方案相比,早期活动与医疗并发症减少相关,而与手术复发无显著影响相关。