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Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial

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机构: [1]Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. [2]China National Clinical Research Center for Neurological Diseases, Beijing, China. [3]Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. [4]Department of Neurosurgery, Beijing Ditan Hospital, Capital Medical University, Beijing, China. [5]Department of Neurosurgery, Xinxing County People's Hospital, Yunfu, Guangdong, China. [6]Department of Neurosurgery, Puning People's Hospital, Puning, Guangdong, China. [7]Department of Neurosurgery, Yancheng Third People's Hospital, Yancheng, Jiangsu, China. [8]Department of Neurosurgery, Hengshui People's Hospital, Hengshui, Hebei, China. [9]Department of Neurosurgery, Wei County Hospital of Traditional Chinese Medicine, Handan, Hebei, China. [10]Department of Neurosurgery, First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China. [11]Department of Neurosurgery, Beijing Luhe Hospital, Capital Medical University, Beijing, China. [12]Department of Neurosurgery, Xiahuayuan District Hospital, Zhangjiakou, Hebei, China. [13]Department of Neurosurgery, Beijing Xuanwu Hospital, Capital Medical University, Beijing, China. [14]Department of Neurosurgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China. [15]Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin, China. [16]Department of Neurosurgery, The Second Nanning People's Hospital, Nanning, Guangxi, China. [17]Department of Neurosurgery, People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China. [18]Department of Neurosurgery, North China University of Science and Technology Affiliated Hospital, Tangshan, Hebei, China. [19]Department of Neurosurgery, First People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.
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关键词: Chronic subdural hematoma Exhaustive drainage Fixed-time drainage Burr-hole craniostomy Recurrence Protocol Randomized controlled trial

摘要:
Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. The drainage is generally removed after 48 h, which can be described as fixed-time drainage strategy. According to literature, the recurrence rate is 5-33% with this strategy. In our retrospective study, postoperative hematoma volume was found to significantly increase the risk of recurrence. Based on these results, an exhaustive drainage strategy is conducted to minimize postoperative hematoma volume and achieve a low recurrence rate and good outcomes.This is a prospective, multicenter, open-label, blinded endpoint randomized controlled trial designed to include 304 participants over the age of 18-90 years presenting with a symptomatic CSDH verified on cranial computed tomography or magnetic resonance imaging. Participants will be randomly allocated to perform exhaustive drainage (treatment group) or fixed-time drainage (control group) after a one-burr hole craniostomy. The primary endpoint will be recurrence indicating a reoperation within 6 months.This study will validate the effect and safety of exhaustive drainage after one-burr hole craniostomy in reducing recurrence rates and provide critical information to improve CSDH surgical management.Clinicaltrials.gov, NCT04573387. Registered on October 5, 2020.© 2023. The Author(s).

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大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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Q4 MEDICINE, RESEARCH & EXPERIMENTAL
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Q3 MEDICINE, RESEARCH & EXPERIMENTAL

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第一作者机构: [1]Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. [2]China National Clinical Research Center for Neurological Diseases, Beijing, China.
通讯作者:
通讯机构: [1]Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. [2]China National Clinical Research Center for Neurological Diseases, Beijing, China.
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