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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

医学 随机对照试验 外科 卧床休息 动员 血肿 随机化 临床试验 格拉斯哥结局量表 慢性硬膜下血肿 前瞻性队列研究 格拉斯哥昏迷指数 内科学 考古 历史
作者
Vanessa Pinto,Sérgio Alves de Sousa,Filipe Vaz da Silva,Tiago Ribeiro da Costa,Armindo Fernandes,Rodrigo Batata,Carolina Noronha,João Monteiro Silva,Sónia Ferreira,Salomé Sobral,Célia Alves,Rui Rangel,Alfredo Calheiros,_ _,Jorge M. Antunes,Miguel Fidalgo,A. Grande,Gonçalo Figueiredo,Licinio Rocha,Eduardo Grala da Cunha,Miguel A. Ferreira,Sérgio Rodrigues Moreira,Ana Lúcia Machado,Márcia Tizziani,Carla Silva,Elsa Silva,Joaquim Reis,Mário Varela Gomes,Célia Pinheiro,Dora Simões,M. Isabel Ribeiro,Pedro Amorim,Sara Barbeiro,Vanessa Andina Teixeira,Sílvia Helena Henriques Camelo,Maria Laura Gonçalves,Graça Maria Alves dos Santos Magalhães,Ana Cristina Rodrigues Lacerda,Ana Paula Couto,Ana Paula Silva,Ana C.F. Ribeiro,Ana Rita Poças,Anabela Neves,Andreia Portela,Andreia Preto,Andreia Queirós,António de Castro Caeiro,Ariana Rocha,Bruna Mateus,Cristiana Pereira,Daniel Ferreira da Cunha,Daniela M. Sousa,Elsa Oliveira,Ema Paula Ribeiro,Hélder Roberto de Oliveira Rocha,Inês A. Barbosa,Inês Carvalho,Inês Cunha,Inês Lima,Inês Falcão-Pires,Inês Maria Meneses dos Santos,Isabel Pavão Martins,Isabel Ramos,Joana Silva,Jorge Castanheira,J.A.M. Ferreira,Júlia Leitão,Juliana Silva,Leonela Margarita Torre,Lucília Alves,Manuel Sá Pinto,Margarida Chagas Lopes,Maria do Céu Amaral,Maria João Rocha Melo,Maria José Cyhlar Monteiro,Maria Teresa Lisboa,Mariana Silva,Marília Saffarizadeh,Marisa Moreira,Luz Marlene,Noémia Costa,Patrícia Capas,Rita Quintela,Rui Silva,Rui Neto,Rui Santos,Sílvia Silva,Simão Pinto,Sofia Queirós,Tiago Oliveira
出处
期刊:Journal of Neurosurgery [American Association of Neurological Surgeons]
卷期号:: 1-8
标识
DOI:10.3171/2023.8.jns231509
摘要

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.
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