Sun Tong, You Chao, Ma Lu, Yuan Yikai, Yang Jingguo, Tian Meng, Zhou Yicheng, Guan Junwen
Department of Neurosurgery.
West China Brain Research Center.
Medicine (Baltimore). 2020 Jul 2;99(27):e20528. doi: 10.1097/MD.0000000000020528.
Ventriculoperitoneal shunt (VPS) surgery remains the most widely accepted and used option method to treat post-hemorrhagic hydrocephalus (PHH) worldwide while lumboperitoneal shunt (LPS) serves as an effectively alternative treatment. However, the outcomes of VPS and LPS in the treatment of PHH have not been compared in a prospective trial.
In this monocentric, assessor-blinded, non-randomized controlled trial, 75 eligible patients with PHH for each group will be recruited to compare the outcomes of VPS cohort with that of LPS cohort. Each participant is evaluated before surgery, at the time of discharge, 3, and 6 months after surgery by experienced and practiced assessors. The primary outcome is the rate of shunt failure 6 months after shunt surgery. The secondary measure of efficacy is National Institute of Health stroke scale, together along with Glasgow coma scale, modified Rankin Scale, and Evans index at the evaluation point. A favorable outcome is defined as shunt success with an improvement of more than 1 point in the National Institute of Health stroke scale. Complication events occurring within 6 months after surgery are investigated. A serious adverse events throughout the study are recorded regarding the safety of shunts.
The results of this trial will provide evidence for the treatment options for patients with PHH.
脑室腹腔分流术(VPS)仍是全球治疗出血后脑积水(PHH)最广泛接受和使用的选择方法,而腰大池腹腔分流术(LPS)是一种有效的替代治疗方法。然而,VPS和LPS治疗PHH的疗效尚未在前瞻性试验中进行比较。
在这项单中心、评估者盲法、非随机对照试验中,将每组招募75例符合条件的PHH患者,以比较VPS队列和LPS队列的疗效。由经验丰富的评估者在手术前、出院时、术后3个月和6个月对每位参与者进行评估。主要结局是分流术后6个月的分流失败率。疗效的次要指标是美国国立卫生研究院卒中量表,以及评估时的格拉斯哥昏迷量表、改良Rankin量表和埃文斯指数。良好结局定义为分流成功且美国国立卫生研究院卒中量表改善超过1分。调查术后6个月内发生的并发症事件。记录整个研究过程中关于分流安全性的严重不良事件。
本试验结果将为PHH患者的治疗选择提供依据。