冲洗液温度对慢性硬膜下血肿引流术后复发的影响：一项随机临床试验。
Effect of Irrigation Fluid Temperature on Recurrence in the Evacuation of Chronic Subdural Hematoma: A Randomized Clinical Trial.
机构信息
Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, University of Gothenburg, Sahlgrenska Academy, Gothenburg, Sweden.
Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
出版信息
JAMA Neurol. 2023 Jan 1;80(1):58-63. doi: 10.1001/jamaneurol.2022.4133.
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.
重要性
冲洗液的物理性质（体温与室温）对慢性硬膜下血肿（cSDH）清除术后复发率的影响仍需进一步研究。
目的
探讨冲洗液温度是否对 cSDH 复发有影响。
设计、地点和参与者：这是一项于 2016 年 3 月 16 日至 2020 年 5 月 30 日在瑞典 3 个神经外科中心进行的多中心随机临床试验。随访期为 6 个月。所有在研究期间接受 cSDH 清除术的年龄大于 18 岁的患者均被筛选入组。
干预措施
研究参与者通过 1:1 区组随机分组，接受室温（RT 组）或体温（BT 组）冲洗液的 cSDH 清除术。
主要结局和测量指标
主要终点是 6 个月内需要再次手术的复发。次要终点是死亡率、健康相关生活质量和并发症发生率。
结果
术后 6 个月，根据方案，541 例（平均[标准差]年龄，75.8[9.8]岁；395 例男性[73%]）患者完成了完整随访。RT 组中有 277 例复发（14%）需要再次手术，BT 组中有 264 例复发（6%）需要再次手术（比值比，2.56；95%置信区间，1.38-4.66；P<0.001）。死亡率、健康相关生活质量或并发症发生率无显著差异。
结论和相关性
在这项研究中，与室温冲洗相比，体温冲洗在减少复发方面更具优势。这是一种简单、安全且易于获得的技术，可以优化 cSDH 患者的预后。在 cSDH 手术中使用冲洗时，应考虑将体温冲洗作为标准治疗。
试验注册
ClinicalTrials.gov 标识符：NCT02757235。
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