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 () 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 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 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 22 [7·5%] of 294 participants who received irrigation), intracranial haemorrhage (13 [4·4%] seven [2·4%]), and epileptic seizures (five [1·7%] 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.

中文翻译：

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钻孔引流联合或不联合冲洗治疗慢性硬膜下血肿 (FINISH)：一项芬兰全国性、平行组、多中心、随机、对照、非劣效性试验


慢性硬膜下血肿是一种常见的颅内急症手术治疗。钻孔引流手术用于清除慢性硬膜下血肿，涉及三个要素：创建用于进入的钻孔、冲洗硬膜下腔以及插入硬膜下引流管。尽管硬膜下引流已被证实是有益的，但硬膜下冲洗的治疗效果尚未得到解决。 FINISH 试验是一项由研究者发起、务实、多中心、全国性、随机、对照、平行组、非劣效性试验，在芬兰的五个神经外科单位进行，招募了 18 岁或以上患有需要钻孔的慢性硬膜下血肿的成年人引流。通过计算机生成的区块随机化（区块大小为四、六或八，按部位分层）将患者随机分配（1:1），进行钻孔引流，无论是否有硬膜下冲洗。除了神经外科医生和手术室工作人员之外，所有患者和工作人员都对治疗分配不知情。两组均在最大血肿厚度处钻钻孔，在插入硬膜下引流管之前冲洗或不冲洗硬膜下腔，并将其保留在原位48小时。记录术后 6 个月的再次手术、功能结果、死亡率和不良事件。主要结局是6个月内的再手术率。非劣效性幅度设定为7·5%。得出非劣效性结论还需要的关键次要结局是具有不利功能结局的参与者的比例（即，改良Rankin量表评分为4-6，其中0表示无症状，6表示死亡）和6个月时的死亡率。 主要分析和关键次要分析均在意向治疗人群和符合方案人群中进行。试验已在（）处注册并已完成。从2020年1月1日到2022年8月17日，我们评估了1644名患者的资格，其中589名（36%）名患者被随机分配到治疗组并接受治疗（294名分配至带冲洗引流组，295名分配至不带冲洗引流组；165 [28%] 女性和 424 [72%] 男性）。 6 个月的随访期延长至 2023 年 2 月 14 日。在意向治疗分析中，295 名参与者中有 54 名 (18·3%) 被分配接受不接受冲洗的组需要再次手术，而被分配接受冲洗的组中有 37 名 (12·6分配接受灌溉的组中 294 人的 %）（差异 6·0 个百分点，95% CI 0·2–11·7；p=0·30；根据研究地点进行调整）。改良Rankin量表得分为4-6的人数比例没有显着的组间差异（无灌溉组283人中有37人[13·1%]，灌溉组285人中有36人[12·6%]）组；p=0·89）或死亡率（无灌溉组 295 人中 18 [6·1%]；灌溉组 294 人中 21 [7·1%]；p=0·58）。主要意向治疗分析的结果在符合方案分析中没有发生实质性改变。不良事件的数量没有显着的组间差异，最常见的严重不良事件是全身感染（295 名参与者中的 26 名 [8·8%] 未接受冲洗；294 名参与者中的 22 名 [7·5%]接受冲洗的参与者）、颅内出血（13 [4·4%] 7 [2·4%]）和癫痫发作（5 [1·7%] 9 [3·1%]）。我们不能得出不灌溉的钻孔排水的非劣效性。 钻孔引流不加硬膜下冲洗的再手术率比硬膜下冲洗高6·0个百分点。考虑到各组之间的功能结果或死亡率没有差异，该试验倾向于使用硬膜下冲洗。国家大学级健康研究基金（赫尔辛基大学医院）、Finska Läkaresällskapet、Medicinska Understödsföreningen Liv och Hälsa 和 Svenska Kulturfonden。