BACKGROUND:Hypertensive intracerebral haemorrhage (HICH) is the most common form of haemorrhagic stroke with the highest morbidity and mortality of all stroke types. The choice of surgical or conservative treatment for patients with HICH remains controversial. In recent years, minimally invasive surgeries, such as endoscopic evacuation and stereotactic aspiration, have been attempted for haematoma removal and offer promise. However, research evidence on the benefits of endoscopic evacuation or stereotactic aspiration is still insufficient. METHODS/DESIGN:A multicentre, randomised controlled trial will be conducted to compare the efficacy of endoscopic evacuation, stereotactic aspiration and craniotomy in the treatment of supratentorial HICH. About 1350 eligible patients from 10 neurosurgical centres will be randomly assigned to an endoscopic group, a stereotactic group and a craniotomy group at a 1:1:1 ratio. Randomisation is undertaken using a 24-h randomisation service accessed by telephone or the Internet. All patients will receive the corresponding surgery based on their grouping. They will be followed-up at 1, 3 and 6 months after surgery. The primary outcome is the modified Rankin Scale at 6-month follow-up. Secondary outcomes include: haematoma clearance rate; Glasgow Coma Scale 7 days after surgery; rebleeding rate; intracranial infection rate; hospitalisation time; mortality at 1 month and 3 months after surgery; the Barthel Index and the WHO quality of life at 3 months and 6 months after surgery. DISCUSSION:The trial aims to investigate whether endoscopic evacuation and stereotactic aspiration could improve the outcome of supratentorial HICH compared with craniotomy. The trial will help to determine the best surgical method for the treatment of supratentorial HICH. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02811614 . Registered on 20 June 2016.

译文

背景:高血压脑出血(HICH)是出血性中风的最常见形式,在所有中风类型中发病率和死亡率最高。对于HICH患者,手术或保守治疗的选择仍存在争议。近年来,已经尝试了微创手术,例如内窥镜排空和立体定向抽吸术,以去除血肿并提供了希望。但是,关于内窥镜排空或立体定向抽吸术的益处的研究证据仍然不足。
方法/设计:将进行一项多中心,随机对照试验,以比较内镜排空,立体定向抽吸和开颅手术治疗幕上HICH的疗效。来自10个神经外科中心的约1350名合格患者将以1:1:1的比例随机分配到内窥镜组,立体定位组和颅骨切开术组。随机化是通过电话或互联网访问的24小时随机化服务进行的。所有患者将根据其分组接受相应的手术。他们将在手术后的1、3和6个月进行随访。主要结果是修订后的6个月随访中的Rankin量表。次要结果包括:血肿清除率;手术后7天的格拉斯哥昏迷量表;再出血率颅内感染率;住院时间;术后1个月和3个月的死亡率;术后3个月和6个月的Barthel指数和WHO的生活质量。
讨论:该试验旨在研究内镜腔内抽空和立体定向抽吸术是否比开颅手术能改善幕上HICH的预后。该试验将有助于确定治疗幕上HICH的最佳手术方法。
试用注册:ClinicalTrials.gov,ID:NCT02811614。 2016年6月20日注册。

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