Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial

Andreas Bartley; Jiri Bartek; Asgeir S Jakola; Jimmy Sundblom; Marie Fält; Petter Förander; Niklas Marklund; Magnus Tisell

doi:10.1001/jamaneurol.2022.4133

Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial

Andreas Bartley, Jiri Bartek, Asgeir S Jakola, Jimmy Sundblom, Marie Fält, Petter Förander, Niklas Marklund, Magnus Tisell

Department of Neurosurgery

15 Citations (Scopus)

Abstract

IMPORTANCE: The effect of a physical property of irrigation fluid (at body vs room temperature) on recurrence rate in the evacuation of chronic subdural hematoma (cSDH) needs further study.

OBJECTIVE: To explore whether irrigation fluid temperature has an influence on cSDH recurrence.

DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter randomized clinical trial performed between March 16, 2016, and May 30, 2020. The follow-up period was 6 months. The study was conducted at 3 neurosurgical departments in Sweden. All patients older than 18 years undergoing cSDH evacuation during the study period were screened for eligibility in the study.

INTERVENTIONS: The study participants were randomly assigned by 1:1 block randomization to the cSDH evacuation procedure with irrigation fluid at room temperature (RT group) or at body temperature (BT group).

MAIN OUTCOMES AND MEASURES: The primary end point was recurrence requiring reoperation within 6 months. Secondary end points were mortality, health-related quality of life, and complication frequency.

RESULTS: At 6 months after surgery, 541 patients (mean [SD] age, 75.8 [9.8] years; 395 men [73%]) had a complete follow-up according to protocol. There were 39 of 277 recurrences (14%) requiring reoperation in the RT group, compared with 16 of 264 recurrences (6%) in the BT group (odds ratio, 2.56; 95% CI, 1.38-4.66; P < .001). There were no significant differences in mortality, health-related quality of life, or complication frequency.

CONCLUSIONS AND RELEVANCE: In this study, irrigation at body temperature was superior to irrigation at room temperature in terms of fewer recurrences. This is a simple, safe, and readily available technique to optimize outcome in patients with cSDH. When irrigation is used in cSDH surgery, irrigation fluid at body temperature should be considered standard of care.

TRIAL REGISTRATION: ClincalTrials.gov Identifier: NCT02757235.

Original language	English
Journal	JAMA Neurology
Volume	80
Issue number	1
Pages (from-to)	58-63
Number of pages	6
ISSN	2168-6149
DOIs	https://doi.org/10.1001/jamaneurol.2022.4133
Publication status	Published - 1 Jan 2023

Keywords

Aged
Drainage/methods
Hematoma, Subdural, Chronic/surgery
Humans
Male
Neoplasm Recurrence, Local
Quality of Life
Recurrence
Reoperation
Temperature
Treatment Outcome

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10.1001/jamaneurol.2022.4133

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title = "Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial",

abstract = "IMPORTANCE: The effect of a physical property of irrigation fluid (at body vs room temperature) on recurrence rate in the evacuation of chronic subdural hematoma (cSDH) needs further study.OBJECTIVE: To explore whether irrigation fluid temperature has an influence on cSDH recurrence.DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter randomized clinical trial performed between March 16, 2016, and May 30, 2020. The follow-up period was 6 months. The study was conducted at 3 neurosurgical departments in Sweden. All patients older than 18 years undergoing cSDH evacuation during the study period were screened for eligibility in the study.INTERVENTIONS: The study participants were randomly assigned by 1:1 block randomization to the cSDH evacuation procedure with irrigation fluid at room temperature (RT group) or at body temperature (BT group).MAIN OUTCOMES AND MEASURES: The primary end point was recurrence requiring reoperation within 6 months. Secondary end points were mortality, health-related quality of life, and complication frequency.RESULTS: At 6 months after surgery, 541 patients (mean [SD] age, 75.8 [9.8] years; 395 men [73%]) had a complete follow-up according to protocol. There were 39 of 277 recurrences (14%) requiring reoperation in the RT group, compared with 16 of 264 recurrences (6%) in the BT group (odds ratio, 2.56; 95% CI, 1.38-4.66; P < .001). There were no significant differences in mortality, health-related quality of life, or complication frequency.CONCLUSIONS AND RELEVANCE: In this study, irrigation at body temperature was superior to irrigation at room temperature in terms of fewer recurrences. This is a simple, safe, and readily available technique to optimize outcome in patients with cSDH. When irrigation is used in cSDH surgery, irrigation fluid at body temperature should be considered standard of care.TRIAL REGISTRATION: ClincalTrials.gov Identifier: NCT02757235.",

keywords = "Aged, Drainage/methods, Hematoma, Subdural, Chronic/surgery, Humans, Male, Neoplasm Recurrence, Local, Quality of Life, Recurrence, Reoperation, Temperature, Treatment Outcome",

author = "Andreas Bartley and Jiri Bartek and Jakola, {Asgeir S} and Jimmy Sundblom and Marie F{\"a}lt and Petter F{\"o}rander and Niklas Marklund and Magnus Tisell",

year = "2023",

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doi = "10.1001/jamaneurol.2022.4133",

language = "English",

volume = "80",

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T1 - Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma

T2 - A Randomized Clinical Trial

AU - Bartley, Andreas

AU - Bartek, Jiri

AU - Jakola, Asgeir S

AU - Sundblom, Jimmy

AU - Fält, Marie

AU - Förander, Petter

AU - Marklund, Niklas

AU - Tisell, Magnus

PY - 2023/1/1

Y1 - 2023/1/1

N2 - IMPORTANCE: The effect of a physical property of irrigation fluid (at body vs room temperature) on recurrence rate in the evacuation of chronic subdural hematoma (cSDH) needs further study.OBJECTIVE: To explore whether irrigation fluid temperature has an influence on cSDH recurrence.DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter randomized clinical trial performed between March 16, 2016, and May 30, 2020. The follow-up period was 6 months. The study was conducted at 3 neurosurgical departments in Sweden. All patients older than 18 years undergoing cSDH evacuation during the study period were screened for eligibility in the study.INTERVENTIONS: The study participants were randomly assigned by 1:1 block randomization to the cSDH evacuation procedure with irrigation fluid at room temperature (RT group) or at body temperature (BT group).MAIN OUTCOMES AND MEASURES: The primary end point was recurrence requiring reoperation within 6 months. Secondary end points were mortality, health-related quality of life, and complication frequency.RESULTS: At 6 months after surgery, 541 patients (mean [SD] age, 75.8 [9.8] years; 395 men [73%]) had a complete follow-up according to protocol. There were 39 of 277 recurrences (14%) requiring reoperation in the RT group, compared with 16 of 264 recurrences (6%) in the BT group (odds ratio, 2.56; 95% CI, 1.38-4.66; P < .001). There were no significant differences in mortality, health-related quality of life, or complication frequency.CONCLUSIONS AND RELEVANCE: In this study, irrigation at body temperature was superior to irrigation at room temperature in terms of fewer recurrences. This is a simple, safe, and readily available technique to optimize outcome in patients with cSDH. When irrigation is used in cSDH surgery, irrigation fluid at body temperature should be considered standard of care.TRIAL REGISTRATION: ClincalTrials.gov Identifier: NCT02757235.

AB - IMPORTANCE: The effect of a physical property of irrigation fluid (at body vs room temperature) on recurrence rate in the evacuation of chronic subdural hematoma (cSDH) needs further study.OBJECTIVE: To explore whether irrigation fluid temperature has an influence on cSDH recurrence.DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter randomized clinical trial performed between March 16, 2016, and May 30, 2020. The follow-up period was 6 months. The study was conducted at 3 neurosurgical departments in Sweden. All patients older than 18 years undergoing cSDH evacuation during the study period were screened for eligibility in the study.INTERVENTIONS: The study participants were randomly assigned by 1:1 block randomization to the cSDH evacuation procedure with irrigation fluid at room temperature (RT group) or at body temperature (BT group).MAIN OUTCOMES AND MEASURES: The primary end point was recurrence requiring reoperation within 6 months. Secondary end points were mortality, health-related quality of life, and complication frequency.RESULTS: At 6 months after surgery, 541 patients (mean [SD] age, 75.8 [9.8] years; 395 men [73%]) had a complete follow-up according to protocol. There were 39 of 277 recurrences (14%) requiring reoperation in the RT group, compared with 16 of 264 recurrences (6%) in the BT group (odds ratio, 2.56; 95% CI, 1.38-4.66; P < .001). There were no significant differences in mortality, health-related quality of life, or complication frequency.CONCLUSIONS AND RELEVANCE: In this study, irrigation at body temperature was superior to irrigation at room temperature in terms of fewer recurrences. This is a simple, safe, and readily available technique to optimize outcome in patients with cSDH. When irrigation is used in cSDH surgery, irrigation fluid at body temperature should be considered standard of care.TRIAL REGISTRATION: ClincalTrials.gov Identifier: NCT02757235.

KW - Aged

KW - Drainage/methods

KW - Hematoma, Subdural, Chronic/surgery

KW - Humans

KW - Male

KW - Neoplasm Recurrence, Local

KW - Quality of Life

KW - Recurrence

KW - Reoperation

KW - Temperature

KW - Treatment Outcome

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DO - 10.1001/jamaneurol.2022.4133

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SN - 2168-6149

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JO - JAMA Neurology

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ER -

Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial

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