Evidence map›Paper›PMID 38166992›Full record

ArticleTrials2024

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 and 17 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 19 institutions in 1 country.

Yoshitaka NagashimaDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. y-nagashima@med.nagoya-u.ac.jp.ORCID http://orcid.org/0000-0001-9346-1663
Yoshio ArakiDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Kazuki NishidaDepartment of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.
Shunichiro KuramitsuDepartment of Neurosurgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Kenichi WakabayashiDepartment of Neurosurgery, Toyohashi Municipal Hospital, Toyohashi, Japan.
Shinji ShimatoDepartment of Neurosurgery, Handa City Hospital, Handa, Japan.
Takeshi KinkoriDepartment of Neurosurgery, Okazaki City Hospital, Okazaki, Japan.
Toshihisa NishizawaDepartment of Neurosurgery, Kariya Toyota General Hospital, Kariya, Japan.
Takahisa KanoDepartment of Neurosurgery, Anjo Kosei Hospital, Anjo, Japan.
Toshinori HasegawaDepartment of Neurosurgery, Komaki City Hospital, Komaki, Japan.
Atsushi NodaDepartment of Neurosurgery, Nishio Municipal Hospital, Nishio, Japan.
Kenko MaedaDepartment of Neurosurgery, JCHO Chukyo Hospital, Nagoya, Japan.
Yu YamamotoDepartment of Neurosurgery, Inazawa Municipal Hospital, Inazawa, Japan.
Osamu SuzukiDepartment of Neurosurgery, Nagoya Ekisaikai Hospital, Nagoya, Japan.
Naoki KoketsuDepartment of Neurosurgery, Tosei General Hospital, Seto, Japan.
Takeshi OkadaDepartment of Neurosurgery, Kainan Hospital, Yatomi, Japan.
Masashige IwasakiDepartment of Neurosurgery, Shizuoka Saiseikai General Hospital, Shizuoka, Japan.
Kiyo NakabayashiDepartment of Neurosurgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan.
Shigeru FujitaniDepartment of Neurosurgery, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya, Japan.
Hideki MakiDepartment of Neurosurgery, Ogaki Municipal Hospital, Ogaki, Japan.
Yachiyo KuwatsukaDepartment of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.
Masahiro NishihoriDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Takafumi TaneiDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Tomohide NishikawaDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Yusuke NishimuraDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Ryuta SaitoDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Tokai Neurosurgical disorder Research Group CSDH Study investigators
Nagoya University · JPKanazawa Municipal Hospital · JPNagoya University Hospital · JPTosei General Hospital · JPToyohashi Municipal Hospital · JPHanda City Hospital · JPKinan Hospital · JPNagoya Ekisaikai Hospital · JPYokkaichi Municipal Hospital · JPAnjo Kosei Hospital · JPChukyo Hospital · JPJapanese Red Cross Nagoya Daiichi Hospital · JPJapanese Red Cross Nagoya Daini Hospital · JPKariya Toyota General Hospital · JPKomaki City Hospital · JPNational Hospital Organization · JPOgaki Municipal Hospital · JPOkazaki City Hospital · JPShizuoka Saiseikai General Hospital · JP

Funding

Nagoya University Hospital 2022 Advanced Medical Development Expense Public RecruitmentNagoya University Hospital 2023 Advanced Medical Development Expense Public RecruitmentThe Japan Society of NEUROTRAUMATOLOGY the 3rd Young Investigator Clinical Research Support Project
6 · The paper itself

Abstract

backgroundThe 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.

methodsThe 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 registrationClinicalTrials.gov jRCT1041220124. Registered on January 13, 2023.

Indexed as

Hematoma, Subdural, ChronicDrainageHumansLength of StayMulticenter Studies as TopicRandomized Controlled Trials as TopicRecurrenceReoperationRetrospective StudiesTomography, X-Ray ComputedTreatment OutcomeArtificial cerebrospinal fluidChronic subdural hematomaIrrigation fluidRecurrenceSurgical evacuation

Identifiers

PMID38166992
PMCPMC10759626
OpenAlexW4390500923

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.