Efficacy of intraoperative irrigation with artificial cerebrospinal fluid in chronic subdural hematoma surgery: study protocol for a multicenter randomized controlled trial
Yoshitaka Nagashima,
Yoshio Araki,
Kazuki Nishida,
Shunichiro Kuramitsu,
Kenichi Wakabayashi,
Shinji Shimato,
Takeshi Kinkori,
Toshihisa Nishizawa,
Takahisa Kano,
Toshinori Hasegawa,
Atsushi Noda,
Kenko Maeda,
Yu Yamamoto,
Osamu Suzuki,
Naoki Koketsu,
Takeshi Okada,
Masashige Iwasaki,
Kiyo Nakabayashi,
Shigeru Fujitani,
Hideki Maki,
Yachiyo Kuwatsuka,
Masahiro Nishihori,
Takafumi Tanei,
Tomohide Nishikawa,
Yusuke Nishimura,
Ryuta Saito,
Tokai Neurosurgical disorder Research Group CSDH Study investigators
Affiliations
Yoshitaka Nagashima
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Yoshio Araki
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Kazuki Nishida
Department of Advanced Medicine, Nagoya University Hospital
Shunichiro Kuramitsu
Department of Neurosurgery, National Hospital Organization Nagoya Medical Center
Kenichi Wakabayashi
Department of Neurosurgery, Toyohashi Municipal Hospital
Shinji Shimato
Department of Neurosurgery, Handa City Hospital
Takeshi Kinkori
Department of Neurosurgery, Okazaki City Hospital
Toshihisa Nishizawa
Department of Neurosurgery, Kariya Toyota General Hospital
Takahisa Kano
Department of Neurosurgery, Anjo Kosei Hospital
Toshinori Hasegawa
Department of Neurosurgery, Komaki City Hospital
Atsushi Noda
Department of Neurosurgery, Nishio Municipal Hospital
Kenko Maeda
Department of Neurosurgery, JCHO Chukyo Hospital
Yu Yamamoto
Department of Neurosurgery, Inazawa Municipal Hospital
Osamu Suzuki
Department of Neurosurgery, Nagoya Ekisaikai Hospital
Naoki Koketsu
Department of Neurosurgery, Tosei General Hospital
Takeshi Okada
Department of Neurosurgery, Kainan Hospital
Masashige Iwasaki
Department of Neurosurgery, Shizuoka Saiseikai General Hospital
Kiyo Nakabayashi
Department of Neurosurgery, Yokkaichi Municipal Hospital
Shigeru Fujitani
Department of Neurosurgery, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Hideki Maki
Department of Neurosurgery, Ogaki Municipal Hospital
Yachiyo Kuwatsuka
Department of Advanced Medicine, Nagoya University Hospital
Masahiro Nishihori
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Takafumi Tanei
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Tomohide Nishikawa
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Yusuke Nishimura
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Ryuta Saito
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Tokai Neurosurgical disorder Research Group CSDH Study investigators
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.
