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Impact of an early mobilization protocol on the reduction of medical complications after surgery for chronic subdural hematoma: the GET-UP Trial

医学 外科 血肿 随机对照试验 随机化 动员 临床试验 并发症 格拉斯哥结局量表 卧床休息 格拉斯哥昏迷指数 内科学 历史 考古
作者
S. G. Sousa,Vasco Pinto,Filipe Vaz da Silva,Tiago Ribeiro da Costa,Armindo Fernandes,Rodrigo Batata,Carolina Noronha,João Silva,Sónia Ferreira,Salomé Sobral Sousa,Célia Alves,Rui Rangel,Alfredo Calheiros,_ _,Jorge M. Antunes,Miguel Fidalgo,Ana Grande,Gonçalo Figueiredo,L.A. Rocha,Eduardo Grala da Cunha
出处
期刊:Journal of Neurosurgery [American Association of Neurological Surgeons]
卷期号:139 (3): 854-863 被引量:14
标识
DOI:10.3171/2023.2.jns222262
摘要

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.
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