학술논문
Efficacy of intraoperative irrigation with artificial cerebrospinal fluid in chronic subdural hematoma surgery: study protocol for a multicenter randomized controlled trial.
Document Type
Article
Author
Nagashima, Yoshitaka; Araki, Yoshio; Nishida, Kazuki; Kuramitsu, Shunichiro; Wakabayashi, Kenichi; Shimato, Shinji; Kinkori, Takeshi; Nishizawa, Toshihisa; Kano, Takahisa; Hasegawa, Toshinori; Noda, Atsushi; Maeda, Kenko; Yamamoto, Yu; Suzuki, Osamu; Koketsu, Naoki; Okada, Takeshi; Iwasaki, Masashige; Nakabayashi, Kiyo; Fujitani, Shigeru; Maki, Hideki
Source
Subject
*SUBDURAL hematoma
*RANDOMIZED controlled trials
*CEREBROSPINAL fluid
*IRRIGATION
*RESEARCH protocols
*DURA mater
*RHINORRHEA
*CEREBROSPINAL fluid examination
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Language
ISSN
1745-6215
Abstract
Background: The surgical techniques for treatment of chronic subdural hematoma (CSDH), a common neurosurgical condition, have been discussed in a lot of clinical literature. However, the recurrence proportion after CSDH surgery remains high, ranging from 10 to 20%. The standard surgical procedure for CSDH involves a craniostomy to evacuate the hematoma, but irrigating the hematoma cavity during the procedure is debatable. The authors hypothesized that the choice of irrigation fluid might be a key factor affecting the outcomes of surgery. This multicenter randomized controlled trial aims to investigate whether intraoperative irrigation using artificial cerebrospinal fluid (ACF) followed by the placement of a subdural drain would yield superior results compared to the placement of a subdural drain alone for CSDH. Methods: The study will be conducted across 19 neurosurgical departments in Japan. The 1186 eligible patients will be randomly allocated to two groups: irrigation using ACF or not. In either group, a subdural drain is to be placed for at least 12 h postoperatively. Similar to what was done in previous studies, we set the proportion of patients that meet the criteria for ipsilateral reoperation at 7% in the irrigation group and 12% in the non-irrigation group. The primary endpoint is the proportion of patients who meet the criteria for ipsilateral reoperation within 6 months of surgery (clinical worsening of symptoms and increased hematoma on imaging compared with the postoperative state). The secondary endpoints are the proportion of reoperations within 6 months, the proportion being stratified by preoperative hematoma architecture by computed tomography (CT) scan, neurological symptoms, patient condition, mortality at 6 months, complications associated with surgery, length of hospital stay from surgery to discharge, and time of the surgical procedure. Discussion: We present the study protocol for a multicenter randomized controlled trial to investigate our hypothesis that intraoperative irrigation with ACF reduces the recurrence proportion after the removal of chronic subdural hematomas compared with no irrigation. Trial registration: ClinicalTrials.gov jRCT1041220124. Registered on January 13, 2023. [ABSTRACT FROM AUTHOR]