Department of Neurosurgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Department of Neurosurgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Lancet. 2024 Jun 29;403(10446):2798-2806. doi: 10.1016/S0140-6736(24)00686-X. Epub 2024 Jun 6.
Chronic subdural haematoma is a common surgically treated intracranial emergency. Burr-hole drainage surgery, to evacuate chronic subdural haematoma, involves three elements: creation of a burr hole for access, irrigation of the subdural space, and insertion of a subdural drain. Although the subdural drain has been established as beneficial, the therapeutic effect of subdural irrigation has not been addressed.
The FINISH trial was an investigator-initiated, pragmatic, multicentre, nationwide, randomised, controlled, parallel-group, non-inferiority trial in five neurosurgical units in Finland that enrolled adults aged 18 years or older with a chronic subdural haematoma requiring burr-hole drainage. Patients were randomly assigned (1:1) by computer-generated block randomisation with block sizes of four, six, or eight, stratified by site, to burr-hole drainage either with or without subdural irrigation. All patients and staff were masked to treatment assignment apart from the neurosurgeon and operating room staff. A burr hole was drilled at the site of maximum haematoma thickness in both groups, and the subdural space was either irrigated or not irrigated before inserting a subdural drain, which remained in place for 48 h. Reoperations, functional outcome, mortality, and adverse events were recorded for 6 months after surgery. The primary outcome was the reoperation rate within 6 months. The non-inferiority margin was set at 7·5%. Key secondary outcomes that were also required to conclude non-inferiority were the proportion of participants with unfavourable functional outcomes (ie, modified Rankin Scale score of 4-6, where 0 indicates no symptoms and 6 indicates death) and mortality rate at 6 months. The primary and key secondary analyses were done in both the intention-to-treat and per-protocol populations. The trial was registered with ClinicalTrials.gov (NCT04203550) and is completed.
From Jan 1, 2020, to Aug 17, 2022, we assessed 1644 patients for eligibility and 589 (36%) patients were randomly assigned to a treatment group and treated (294 assigned to drainage with irrigation and 295 assigned to drainage without irrigation; 165 [28%] women and 424 [72%] men). The 6-month follow-up period extended until Feb 14, 2023. In the intention-to-treat analysis, 54 (18·3%) of 295 participants required reoperation in the group assigned to receive no irrigation versus 37 (12·6%) of 294 in the group assigned to receive irrigation (difference of 6·0 percentage points, 95% CI 0·2-11·7; p=0·30; adjusted for study site). There were no significant between-group differences in the proportion of people with modified Rankin Scale score of 4-6 (37 [13·1%] of 283 in the no-irrigation group vs 36 [12·6%] of 285 in the irrigation group; p=0·89) or mortality rate (18 [6·1%] of 295 in the no-irrigation group vs 21 [7·1%] of 294 in the irrigation group; p=0·58). The findings of the primary intention-to-treat analysis were not materially altered in the per-protocol analysis. There were no significant between-group differences in the number of adverse events, and the most frequent severe adverse events were systemic infections (26 [8·8%] of 295 participants who did not receive irrigation vs 22 [7·5%] of 294 participants who received irrigation), intracranial haemorrhage (13 [4·4%] vs seven [2·4%]), and epileptic seizures (five [1·7%] vs nine [3·1%]).
We could not conclude non-inferiority of burr-hole drainage without irrigation. The reoperation rate was 6·0 percentage points higher after burr-hole drainage without subdural irrigation than with subdural irrigation. Considering that there were no differences in functional outcome or mortality between the groups, the trial favours the use of subdural irrigation.
State Fund for University Level Health Research (Helsinki University Hospital), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv och Hälsa, and Svenska Kulturfonden.
慢性硬膜下血肿是一种常见的需手术治疗的颅内急症。颅骨钻孔引流术用于清除慢性硬膜下血肿,涉及三个要素:创建进入颅骨的骨孔、冲洗硬脑膜下腔和插入硬脑膜下引流管。尽管硬脑膜下引流管已被证明是有益的,但硬脑膜下冲洗的治疗效果尚未得到解决。
FINISH 试验是芬兰五家神经外科单位进行的一项由研究者发起的、实用的、多中心、全国性、随机、对照、平行组、非劣效性试验,纳入了需要颅骨钻孔引流的慢性硬膜下血肿的成年患者(年龄 18 岁或以上)。患者按计算机生成的 4、6 或 8 个块的随机分组,按部位分层,分为颅骨钻孔引流加或不加硬脑膜下冲洗组。除神经外科医生和手术室工作人员外,所有患者和工作人员对治疗方案均不知情。两组均在血肿最厚处钻一个骨孔,并在插入硬脑膜下引流管之前冲洗或不冲洗硬脑膜下腔,引流管保留 48 小时。术后 6 个月记录再手术率、功能结局、死亡率和不良事件。主要结局是 6 个月内的再手术率。非劣效性边界设定为 7.5%。也是需要得出非劣效性结论的关键次要结局包括参与者功能结局不良(即改良 Rankin 量表评分 4-6,其中 0 表示无症状,6 表示死亡)的比例和 6 个月时的死亡率。主要和关键次要分析均在意向治疗和方案人群中进行。该试验在 ClinicalTrials.gov (NCT04203550)上注册,现已完成。
从 2020 年 1 月 1 日至 2022 年 8 月 17 日,我们评估了 1644 名患者的纳入标准,其中 589 名(36%)患者被随机分配到治疗组并接受治疗(294 名接受引流加冲洗,295 名接受引流不加冲洗;165 名女性[28%]和 424 名男性[72%])。6 个月的随访期延长至 2023 年 2 月 14 日。意向治疗分析中,295 名接受无冲洗组的患者中有 54 名(18.3%)需要再次手术,而 294 名接受冲洗组的患者中有 37 名(12.6%)(差异为 6.0 个百分点,95%CI 0.2-11.7;p=0.30;校正了研究地点)。两组之间改良 Rankin 量表评分 4-6 的患者比例(无冲洗组 283 人中有 37 人[13.1%],冲洗组 285 人中有 36 人[12.6%];p=0.89)或死亡率(无冲洗组 295 人中有 18 人[6.1%],冲洗组 294 人中有 21 人[7.1%];p=0.58)均无显著差异。主要意向治疗分析的发现在方案人群分析中没有实质性改变。两组之间不良事件的数量没有显著差异,最常见的严重不良事件是全身感染(295 名未接受冲洗的患者中有 26 名[8.8%],294 名接受冲洗的患者中有 22 名[7.5%])、颅内出血(13 名[4.4%]和 7 名[2.4%])和癫痫发作(5 名[1.7%]和 9 名[3.1%])。
我们不能得出无硬脑膜下冲洗颅骨钻孔引流术的非劣效性结论。无硬脑膜下冲洗的颅骨钻孔引流术后再手术率比硬脑膜下冲洗高 6.0 个百分点。考虑到两组之间的功能结局或死亡率没有差异,该试验倾向于使用硬脑膜下冲洗。
国家大学水平卫生研究基金(赫尔辛基大学医院)、芬兰医师协会、医疗支持协会生活与健康、瑞典文化基金会。