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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

Authors :
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
Source :
Trials, Vol 24, Iss 1, Pp 1-10 (2023)
Publication Year :
2023
Publisher :
BMC, 2023.

Abstract

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.

Details

Language :
English
ISSN :
17456215
Volume :
24
Issue :
1
Database :
Directory of Open Access Journals
Journal :
Trials
Publication Type :
Academic Journal
Accession number :
edsdoj.2a116d747a0f430a92c3e0ceb0334fab
Document Type :
article
Full Text :
https://doi.org/10.1186/s13063-023-07250-y