Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial.
Journal
JAMA neurology
ISSN: 2168-6157
Titre abrégé: JAMA Neurol
Pays: United States
ID NLM: 101589536
Informations de publication
Date de publication:
01 01 2023
01 01 2023
Historique:
pubmed:
22
11
2022
medline:
12
1
2023
entrez:
21
11
2022
Statut:
ppublish
Résumé
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. To explore whether irrigation fluid temperature has an influence on cSDH recurrence. 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. 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). The primary end point was recurrence requiring reoperation within 6 months. Secondary end points were mortality, health-related quality of life, and complication frequency. 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. 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. ClincalTrials.gov Identifier: NCT02757235.
Identifiants
pubmed: 36409480
pii: 2798966
doi: 10.1001/jamaneurol.2022.4133
pmc: PMC9679960
doi:
Banques de données
ClinicalTrials.gov
['NCT02757235']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
58-63Commentaires et corrections
Type : ErratumIn