GET-UP Trial 1-year results: long-term impact of an early mobilization protocol on functional performance after surgery for chronic subdural hematoma
Author:
Pinto Vasco123, Sousa Sérgio Alves1, Vaz da Silva Filipe1, Ribeiro da Costa Tiago1, Fernandes Armindo Picão1, Batata Rodrigo1, Noronha Carolina123, Monteiro Silva João1, Ferreira Sónia1, Sobral Salomé1, Alves Célia1, Rangel Rui1, Calheiros Alfredo12, _ _, Antunes Jorge, Fidalgo Miguel, Grande Ana, Figueiredo Gonçalo, Rocha Luís, Cunha Eduardo, Ferreira Miguel, Moreira Sérgio, Machado Ana, Tizziani Márcia, Silva Carla, Silva Elsa, Reis Joaquim, Gomes Mário, Pinheiro Célia, Simões Dora, Ribeiro Isabel, Amorim Pedro, Barbeiro Sara, Teixeira Vanessa, Henriques Sílvia, Gonçalves Maria Laura, Magalhães Graça, Lacerda Ana, Couto Ana Paula, Silva Ana Paula, Ribeiro Ana, Poças Ana Rita, Neves Anabela, Portela Andreia, Preto Andreia, Queirós Andreia, Caeiro António, Rocha Ariana, Mateus Bruna, Pereira Cristiana, Cunha Daniel, Sousa Daniela, Oliveira Elsa, Ribeiro Ema Paula, Rocha Hélder, Barbosa Inês, Carvalho Inês, Cunha Inês, Lima Inês, Pires Inês, Santos Inês, Martins Isabel, Ramos Isabel, Silva Joana, Castanheira Jorge, Ferreira José, Leitão Júlia, Silva Juliana, Torre Leonela Margarita, Alves Lucília, Pinto Manuel Sá, Lopes Margarida, Amaral Maria do Céu, Melo Maria João Rocha, Monteiro Maria, Lisboa Maria Teresa, Silva Mariana, Saffarizadeh Marília, Moreira Marisa, Luz Marlene, Costa Noémia, Capas Patrícia, Quintela Rita, Silva Rosa, Neto Rui, Santos Rui, Silva Sílvia, Pinto Simão, Queirós Sofia, Oliveira Tiago
Affiliation:
1. Department of Neurosurgery, University Hospital Center of Santo António, Porto; 2. Department of Anatomy, UMIB–Unit for Multidisciplinary Research in Biomedicine, ICBAS–School of Medicine and Biomedical Sciences, University of Porto; and 3. ITR–Laboratory for Integrative and Translational Research in Population Health, Porto, Portugal
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.
Publisher
Journal of Neurosurgery Publishing Group (JNSPG)
Subject
Genetics,Animal Science and Zoology
Reference27 articles.
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