Details

Autor(en) / Beteiligte

• Sousa, Sérgio
• Pinto, Vasco Sá
• da Silva, Filipe V
• da Costa, Tiago R
• Fernandes, Armindo P
• Rangel, Rui
• Calheiros, Alfredo

Titel

Impact of an Early Mobilization Protocol on the Reduction of Medical Complications After Surgery for Chronic Subdural Hematoma – Get Up Randomized Prospective Trial Preliminary Results

Ist Teil von

• Neurosurgery, 2020-12, Vol.67 (Supplement_1)

Ort / Verlag

Philadelphia: Wolters Kluwer Health, Inc

Erscheinungsjahr

2020

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• INTRODUCTION Timing for mobilization after chronic subdural hematoma surgery is a hot topic in the neurosurgical community. Some retrospective studies suggest that early mobilization may lower medical complications without an increase in the recurrence rate, but the literature is scarce on the theme. METHODS Get Up trial is a prospective, randomized, unicentric, open-label and intention-to-treat study that started recruiting patients on January 2019. For an 80% statistical power, to detect 10% differences in primary outcomes, a population of 208 patients is the goal. The study compares two groups: an early mobilization group (intervention group) within 12 hours post-surgery and allowing patients to be mobilized as tolerated, and a control group with bed rest for 48 hours. Primary outcome is the occurrence of medical complications such as infections, seizures and thrombotic events after surgery and until discharge. Secondary outcomes include recurrence and functional outcomes (mRankin scale and GOS-E scale) at discharge and at first outpatient follow-up. RESULTS We present the first 104 randomized patients, with 52 patients in each group. No significant demographic differences were observed between the two groups. Primary outcome occurred in 39% of the controls and in 25% of patients in the intervention group. Infections were diagnosed in 35% and 21% of the control and intervention groups, respectively. Recurrence was the same for the two groups. GOS-E ≥ 5 at discharge was observed in 73% and 83% of the control and intervention groups, respectively. CONCLUSION Get Up trial is performing accordingly with the established protocol. These preliminary results validate the methodology and do not pose security concerns. Although encouraging, these preliminary data must be interpreted as purely descriptive.