119 Impact of an Early Mobilization Protocol on the Reduction of Medical Complications After Surgery for Chronic Subdural Hematoma – GET-UP Trial Interim 1 Year Overview

Abstract

INTRODUCTION:Timing for mobilization after chronic subdural hematoma (CSDH) surgery is highly heterogeneous among neurosurgical centers. No high-quality evidence addresses this question.METHODS:Our aim is to recruit a total of 208 patients. Patients are randomized to either an early mobilization group (EMG) where mobilization is required within the first 12 hours post-surgery; or to a bed rest group (BRG) where they remain recumbent for 48 hours after surgery. The primary outcome is medical complications after surgery and until discharge. Secondary outcomes include evaluation of the functional status at 1 year post-op, using Glasgow Outcome Scale Extended (GOS-E) and Short Form 36 Health Survey (SF-36).RESULTS:We present results of the interim analysis at one year post-op referring to the first 104 randomized patients. A total of 52 patients were randomized to each group. Two patients were lost to follow up at one year. No significant baseline demographic differences were observed. A good outcome was considered when patients achieved GOS-E 5 or higher. At one year we observed a tendency towards better outcome in the EMG group with 71% of the patients having a GOS E = 5 against 54% in the BRG group (p = 0.073). Mortality at 1 year demonstrated a tendency to be lower in the EMG group (21% against 30% in the BRG group, p = 0.305). When we analyze our results based on the SF-36 questionnaire, a tendency toward better performance in the EMG is apparent, especially in the physical performance (p = 0.048), mental health (p = 0.037), vitality (p = 0.043) and general health (p = 0.002) subdivisions.CONCLUSION:GET-UP Trial is performing in accordance with the established protocol. This interim analysis’ results validate the methodology and do not pose security concerns even after 1 year follow-up. Active recruitment is ongoing.