Efficacy of intraoperative irrigation with artificial cerebrospinal fluid in chronic subdural hematoma surgery : study protocol for a multicenter randomized controlled trial
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
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| Enthalten in: |
Trials - 25(2024), 1 vom: 02. Jan., Seite 6 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Nagashima, Yoshitaka [VerfasserIn] |
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| Links: |
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| Themen: |
Artificial cerebrospinal fluid |
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| Anmerkungen: |
Date Completed 05.01.2024 Date Revised 06.01.2024 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s13063-023-07889-7 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM366576216 |
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| 100 | 1 | |a Nagashima, Yoshitaka |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of intraoperative irrigation with artificial cerebrospinal fluid in chronic subdural hematoma surgery |b study protocol for a multicenter randomized controlled trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 06.01.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov jRCT1041220124. Registered on January 13, 2023 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Artificial cerebrospinal fluid | |
| 650 | 4 | |a Chronic subdural hematoma | |
| 650 | 4 | |a Irrigation fluid | |
| 650 | 4 | |a Recurrence | |
| 650 | 4 | |a Surgical evacuation | |
| 700 | 1 | |a Araki, Yoshio |e verfasserin |4 aut | |
| 700 | 1 | |a Nishida, Kazuki |e verfasserin |4 aut | |
| 700 | 1 | |a Kuramitsu, Shunichiro |e verfasserin |4 aut | |
| 700 | 1 | |a Wakabayashi, Kenichi |e verfasserin |4 aut | |
| 700 | 1 | |a Shimato, Shinji |e verfasserin |4 aut | |
| 700 | 1 | |a Kinkori, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Nishizawa, Toshihisa |e verfasserin |4 aut | |
| 700 | 1 | |a Kano, Takahisa |e verfasserin |4 aut | |
| 700 | 1 | |a Hasegawa, Toshinori |e verfasserin |4 aut | |
| 700 | 1 | |a Noda, Atsushi |e verfasserin |4 aut | |
| 700 | 1 | |a Maeda, Kenko |e verfasserin |4 aut | |
| 700 | 1 | |a Yamamoto, Yu |e verfasserin |4 aut | |
| 700 | 1 | |a Suzuki, Osamu |e verfasserin |4 aut | |
| 700 | 1 | |a Koketsu, Naoki |e verfasserin |4 aut | |
| 700 | 1 | |a Okada, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Iwasaki, Masashige |e verfasserin |4 aut | |
| 700 | 1 | |a Nakabayashi, Kiyo |e verfasserin |4 aut | |
| 700 | 1 | |a Fujitani, Shigeru |e verfasserin |4 aut | |
| 700 | 1 | |a Maki, Hideki |e verfasserin |4 aut | |
| 700 | 1 | |a Kuwatsuka, Yachiyo |e verfasserin |4 aut | |
| 700 | 1 | |a Nishihori, Masahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Tanei, Takafumi |e verfasserin |4 aut | |
| 700 | 1 | |a Nishikawa, Tomohide |e verfasserin |4 aut | |
| 700 | 1 | |a Nishimura, Yusuke |e verfasserin |4 aut | |
| 700 | 1 | |a Saito, Ryuta |e verfasserin |4 aut | |
| 700 | 0 | |a Tokai Neurosurgical disorder Research Group CSDH Study investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Maesawa, Satoshi |e investigator |4 oth | |
| 700 | 1 | |a Izumi, Takashi |e investigator |4 oth | |
| 700 | 1 | |a Motomura, Kazuya |e investigator |4 oth | |
| 700 | 1 | |a Ito, Eiji |e investigator |4 oth | |
| 700 | 1 | |a Okumura, Eriko |e investigator |4 oth | |
| 700 | 1 | |a Ohka, Fumiharu |e investigator |4 oth | |
| 700 | 1 | |a Takeuchi, Kazuhito |e investigator |4 oth | |
| 700 | 1 | |a Nagata, Yuichi |e investigator |4 oth | |
| 700 | 1 | |a Yokoyama, Kinya |e investigator |4 oth | |
| 700 | 1 | |a Ishizaki, Tomotaka |e investigator |4 oth | |
| 700 | 1 | |a Kanamori, Fumiaki |e investigator |4 oth | |
| 700 | 1 | |a Fuse, Yutaro |e investigator |4 oth | |
| 700 | 1 | |a Sato, Aya |e investigator |4 oth | |
| 700 | 1 | |a Yukio, Seki |e investigator |4 oth | |
| 700 | 1 | |a Nagatani, Tetsuya |e investigator |4 oth | |
| 700 | 1 | |a Sakamoto, Yusuke |e investigator |4 oth | |
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| 700 | 1 | |a Ishikawa, Takayuki |e investigator |4 oth | |
| 700 | 1 | |a Sasaki, Hiroo |e investigator |4 oth | |
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| 700 | 1 | |a Oyama, Hitofumi |e investigator |4 oth | |
| 700 | 1 | |a Kawaguchi, Tomomi |e investigator |4 oth | |
| 700 | 1 | |a Otsuka, Takafumi |e investigator |4 oth | |
| 700 | 1 | |a Osada, Taiko |e investigator |4 oth | |
| 700 | 1 | |a Matsuyama, Tomoki |e investigator |4 oth | |
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