Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial
Liang Wu,
Yunwei Ou,
Bingcheng Zhu,
Xufei Guo,
Xiaofan Yu,
Long Xu,
Jinping Li,
Enshan Feng,
Huaqing Li,
Xiaodong Wang,
Huaqun Chen,
Zhaosheng Sun,
Zaofu Liu,
Dawei Yang,
Hongbing Zhang,
Zhigang Liu,
Jie Tang,
Shangfeng Zhao,
Guobin Zhang,
Jiemin Yao,
Dongming Ma,
Zelin Sun,
Hui Zhou,
Baiyun Liu,
Weiming Liu,
ECHO Trial Collaborators
Affiliations
Liang Wu
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Yunwei Ou
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Bingcheng Zhu
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Xufei Guo
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Xiaofan Yu
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Long Xu
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Jinping Li
Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University
Enshan Feng
Department of Neurosurgery, Beijing Ditan Hospital, Capital Medical University
Huaqing Li
Department of Neurosurgery, Xinxing County People’s Hospital
Xiaodong Wang
Department of Neurosurgery, Puning People’s Hospital
Huaqun Chen
Department of Neurosurgery, Yancheng Third People’s Hospital
Zhaosheng Sun
Department of Neurosurgery, Hengshui People’s Hospital
Zaofu Liu
Department of Neurosurgery, Wei County Hospital of Traditional Chinese Medicine
Dawei Yang
Department of Neurosurgery, First Hospital of Qinhuangdao
Hongbing Zhang
Department of Neurosurgery, Beijing Luhe Hospital, Capital Medical University
Zhigang Liu
Department of Neurosurgery, Xiahuayuan District Hospital
Jie Tang
Department of Neurosurgery, Beijing Xuanwu Hospital, Capital Medical University
Shangfeng Zhao
Department of Neurosurgery, Beijing Tongren Hospital, Capital Medical University
Guobin Zhang
Department of Neurosurgery, Tianjin Huanhu Hospital
Jiemin Yao
Department of Neurosurgery, The Second Nanning People’s Hospital
Dongming Ma
Department of Neurosurgery, People’s Hospital of Ningxia Hui Autonomous Region
Zelin Sun
Department of Neurosurgery, North China University of Science and Technology Affiliated Hospital
Hui Zhou
Department of Neurosurgery, First People’s Hospital of Lianyungang
Baiyun Liu
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Weiming Liu
Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University
Abstract Background 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. Methods 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. Discussion 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. Trial registration Clinicaltrials.gov, NCT04573387. Registered on October 5, 2020.