OBJECTIVES: To compare the effectiveness of two minimally invasive procedures, namely computed tomography-guided aspiration and the key-hole approach, in the neurosurgical management for spontaneous putaminal haemorrhage, and to explore the indications for the two approaches. DESIGN: A multicentre, single-blinded controlled trial. SETTING: Hospitals taking part in this trial and the sources for patients were from China. Among others, the hospitals involved in the interventions included: the Beijing Tiantan Hospital (of the Capital University of Medical Sciences), the General Hospital of People's Liberation Army, the Peking Union Hospital, and the Shanghai Huashan Hospital (of the Fudan University medical school). PATIENTS: From September 2001 to November 2003, data were available for analysis from a total of 841 patients with spontaneous putaminal haemorrhage from 135 hospitals all over China (except Tibet, Hong Kong, Taiwan, and Macao). All follow-up data were for at least 3 months. MAIN OUTCOME MEASURES: Mortality, Glasgow Coma Scale score, postoperative complications, Kanofsky Performance Scale score, and Barthel Index. RESULTS: There were 563 patients who underwent computed tomography-guided aspiration, and 165 were treated by the key-hole approach. Respective mortality rates 1 month after the operation were 17.9% and 18.3%; at 3 months they were 19.4% and 19.4%. In those undergoing computed tomography-guided aspiration, mortality rates at 3 months after the operation were 28.2% in patients with Glasgow Coma Scale scores of 8 or below, as opposed to 8.2% in those with higher scores. This amounted to a 3.4-fold difference. In those treated by the key-hole approach, the corresponding rates were 30.2% and 7.6%, which amounted to a 4-fold difference. The corresponding mortality at 3 months in patients with complications was 3.9 times as great as in those without complications. In those with haematoma volumes of 70 mL or greater, it was 2.7 times as much as in those in whom the volumes below 30 mL. The postoperative complication rate of computed tomography-guided aspiration (23.7%) did not differ significantly from that in those having the key-hole approach (25.7%) [P=0.420]. CONCLUSIONS: Computed tomography-guided aspiration is not superior to the key-hole approach for treating spontaneous putaminal haemorrhage in terms of favourable outcomes, mortality, and morbidity. However, it could be the first-choice approach for those with bleeds of 50 mL or less, while the key-hole approach may be more suitable for those with larger haematomas.
OBJECTIVES: To compare the effectiveness of two minimally invasive procedures, namely computed tomography-guided aspiration and the key-hole approach, in the neurosurgical management for spontaneous putaminal haemorrhage, and to explore the indications for the two approaches. DESIGN: A multicentre, single-blinded controlled trial. SETTING: Hospitals taking part in this trial and the sources for patients were from China. Among others, the hospitals involved in the interventions included: the Beijing Tiantan Hospital (of the Capital University of Medical Sciences), the General Hospital of People's Liberation Army, the Peking Union Hospital, and the Shanghai Huashan Hospital (of the Fudan University medical school). PATIENTS: From September 2001 to November 2003, data were available for analysis from a total of 841 patients with spontaneous putaminal haemorrhage from 135 hospitals all over China (except Tibet, Hong Kong, Taiwan, and Macao). All follow-up data were for at least 3 months. MAIN OUTCOME MEASURES: Mortality, Glasgow Coma Scale score, postoperative complications, Kanofsky Performance Scale score, and Barthel Index. RESULTS: There were 563 patients who underwent computed tomography-guided aspiration, and 165 were treated by the key-hole approach. Respective mortality rates 1 month after the operation were 17.9% and 18.3%; at 3 months they were 19.4% and 19.4%. In those undergoing computed tomography-guided aspiration, mortality rates at 3 months after the operation were 28.2% in patients with Glasgow Coma Scale scores of 8 or below, as opposed to 8.2% in those with higher scores. This amounted to a 3.4-fold difference. In those treated by the key-hole approach, the corresponding rates were 30.2% and 7.6%, which amounted to a 4-fold difference. The corresponding mortality at 3 months in patients with complications was 3.9 times as great as in those without complications. In those with haematoma volumes of 70 mL or greater, it was 2.7 times as much as in those in whom the volumes below 30 mL. The postoperative complication rate of computed tomography-guided aspiration (23.7%) did not differ significantly from that in those having the key-hole approach (25.7%) [P=0.420]. CONCLUSIONS: Computed tomography-guided aspiration is not superior to the key-hole approach for treating spontaneous putaminal haemorrhage in terms of favourable outcomes, mortality, and morbidity. However, it could be the first-choice approach for those with bleeds of 50 mL or less, while the key-hole approach may be more suitable for those with larger haematomas.