BACKGROUND: Treatment of primary SICH is still controversial. The aim of this study was to investigate the effectiveness of craniotomy and early hematoma evacuation vs nonoperative management in patients with SICH. METHODS: A prospective randomized study of craniotomy and early hematoma removal vs best medical management was performed in 108 patients with primary SICH. Surgical or medical treatment was initiated within 8 hours post ictus. Principal eligibility criterium was the presence of neurologic impairment associated with a spontaneous subcortical or putaminal hemorrhage bigger than 30 mL. Outcomes were assessed at 1 year post ictus. RESULTS: Analysis of outcome revealed a significantly higher percentage of GOS scores higher than 3 for the surgical patients, compared with those of the conservative group (33% and 9%, respectively; P < .05). By contrast, the mortality rates between operated and conservatively managed patients did not differ significantly. The main prognostic variables were the initial neurologic status, hematoma volume, and location. Stratifications of these parameters and analysis showed that the positive effect of surgery on the quality of survival was statistically not valid for patients with GCS scores lower than 8 or ICH volumes 80 mL or higher at the time of enrollment. CONCLUSIONS: The study demonstrates that surgical patients with subcortical or putaminal hematomas showed better functional results than their conservatively treated counterparts. However, early ICH evacuation failed to improve the survival rates, as compared with best medical management.
RCT Entities:
BACKGROUND: Treatment of primary SICH is still controversial. The aim of this study was to investigate the effectiveness of craniotomy and early hematoma evacuation vs nonoperative management in patients with SICH. METHODS: A prospective randomized study of craniotomy and early hematoma removal vs best medical management was performed in 108 patients with primary SICH. Surgical or medical treatment was initiated within 8 hours post ictus. Principal eligibility criterium was the presence of neurologic impairment associated with a spontaneous subcortical or putaminal hemorrhage bigger than 30 mL. Outcomes were assessed at 1 year post ictus. RESULTS: Analysis of outcome revealed a significantly higher percentage of GOS scores higher than 3 for the surgical patients, compared with those of the conservative group (33% and 9%, respectively; P < .05). By contrast, the mortality rates between operated and conservatively managed patients did not differ significantly. The main prognostic variables were the initial neurologic status, hematoma volume, and location. Stratifications of these parameters and analysis showed that the positive effect of surgery on the quality of survival was statistically not valid for patients with GCS scores lower than 8 or ICH volumes 80 mL or higher at the time of enrollment. CONCLUSIONS: The study demonstrates that surgical patients with subcortical or putaminal hematomas showed better functional results than their conservatively treated counterparts. However, early ICH evacuation failed to improve the survival rates, as compared with best medical management.
Authors: Opeolu Adeoye; Daniel Woo; Mary Haverbusch; Padmini Sekar; Charles J Moomaw; Joseph Broderick; Matthew L Flaherty Journal: Neurosurgery Date: 2008-12 Impact factor: 4.654