The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial

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Bartley, AndreasGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience (author)

The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!) : study protocol for a multicenter randomized controlled trial

Article/chapterEnglish2017

Publisher, publication year, extent ...

2017-10-11
BIOMED CENTRAL LTD,2017
electronicrdacarrier

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LIBRIS-ID:oai:DiVA.org:uu-338514
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-338514URI
https://doi.org/10.1186/s13063-017-2194-yDOI
http://kipublications.ki.se/Default.aspx?queryparsed=id:136850743URI
https://gup.ub.gu.se/publication/258122URI

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Language:English
Summary in:English

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Subject category:art swepub-publicationtype

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Background: Chronic subdural hematoma (cSDH) is one of the most common conditions encountered in neurosurgical practice. Recurrence, observed in 5-30% of patients, is a major clinical problem. The temperature of the irrigation fluid used during evacuation of the hematoma might theoretically influence recurrence rates since irrigation fluid at body temperature (37 degrees C) may beneficially influence coagulation and cSDH solubility when compared to irrigation fluid at room temperature. Should no difference in recurrence rates be observed when comparing irrigation-fluid temperatures, there is no need for warmed fluids during surgery. Our main aim is to investigate the effect of irrigation-fluid temperature on recurrence rates and clinical outcomes after cSDH evacuation using a multicenter randomized controlled trial design.Methods: The study will be conducted in three neurosurgical departments with population-based catchment areas using a similar surgical strategy. In total, 600 patients fulfilling the inclusion criteria will randomly be assigned to either intraoperative irrigation with fluid at body temperature or room temperature. The power calculation is based on a retrospective study performed at our department showing a recurrence rate of 5% versus 12% when comparing irrigation fluid at body temperature versus fluid at room temperature (unpublished data). The primary endpoint is recurrence rate of cSDH analyzed at 6 months post treatment. Secondary endpoints are mortality rate, complications and health-related quality of life.Discussion: Irrigation-fluid temperature might influence recurrence rates in the evacuation of chronic subdural hematomas. We present a study protocol for a multicenter randomized controlled trial investigating our hypothesis that irrigation fluid at body temperature is superior to room temperature in reducing recurrence rates following evacuation of cSDH.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Geriatrik hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Geriatrics hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kirurgi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Surgery hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Neurologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Neurology hsv//eng
Chronic subdural hematoma
Surgical evacuation
Recurrence
Irrigation fluid
Temperature
Chronic subdural hematomaSurgical evacuationRecurrenceIrrigation fluidTemperature

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Jakola, Asgeir StoreGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience(Swepub:gu)xjakas (author)
Bartek, Jiri, Jr.Karolinska Institutet,Karolinska Univ Hosp, Dept Neurosurg, Solna, Sweden.;Karolinska Inst, Sect Neurosurg, Dept Clin Neurosci, Stockholm, Sweden.;Rigshosp, Dept Neurosurg, Copenhagen Univ Hosp, Copenhagen, Denmark. (author)
Sundblom, Jimmy,1981-Uppsala universitet,Neurokirurgi(Swepub:uu)jisun109 (author)
Förander, PetterKarolinska Institutet,Karolinska Univ Hosp, Dept Neurosurg, Solna, Sweden.;Karolinska Inst, Sect Neurosurg, Dept Clin Neurosci, Stockholm, Sweden. (author)
Marklund, NiklasUppsala universitet,Neurokirurgi(Swepub:uu)niklmark (author)
Tisell, Magnus,1964Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience(Swepub:gu)xtisma (author)
Göteborgs universitetInstitutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap (creator_code:org_t)

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Geriatrics

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