背景:慢性硬膜下血肿是一种常见的颅内急症。钻孔引流手术,清除慢性硬膜下血肿,涉及三个要素:创建一个用于访问的毛刺孔,冲洗硬膜下空间,并插入硬膜下引流管。虽然硬膜下引流已被确定为有益的,硬膜下冲洗的治疗效果尚未得到解决。
方法:FINISH试验由研究者发起,务实,多中心,全国范围内,随机化,控制,平行组,在芬兰的五个神经外科病房中进行的非劣效性试验,纳入了18岁或以上患有需要钻孔引流的慢性硬膜下血肿的成年人。通过计算机生成的区组随机化将患者随机分配(1:1),区组大小为4,六,或者八个,按地点分层,在有或没有硬膜下冲洗的情况下进行钻孔引流。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都被掩盖了治疗任务。两组均在最大血肿厚度处钻了一个毛刺孔,并且在插入硬膜下引流之前,硬膜下间隙已灌注或未灌注,它保持在原地48小时。再操作,功能结果,死亡率,并记录术后6个月的不良事件。主要结果是6个月内的再手术率。非劣效性利润率设定为7·5%。得出非劣效性还需要的关键次要结果是具有不利功能结果的参与者的比例(即,改良的Rankin量表评分为4-6分,其中0表示无症状,6表示死亡)和6个月时的死亡率。在意向治疗和符合方案的人群中进行了主要和关键的次要分析。该试验已在ClinicalTrials.gov(NCT04203550)注册,并已完成。
结果:从2020年1月1日至2022年8月17日,我们评估了1644例患者的资格,将589例(36%)患者随机分配到治疗组并接受治疗(294例分配给冲洗引流,295例分配给不冲洗引流;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,在分配给不接受灌溉的组中,295名参与者中有54名(18·3%)需要再次手术,而在分配给接受灌溉的组中,294名参与者中有37名(12·6%)(差异为6·0个百分点,95%CI0·2-11·7;p=0·30;根据研究地点调整)。改良Rankin量表评分为4-6分(无灌溉组283人中的37[13·1%]与285人中的36[12·6%]在两组之间没有显着差异。灌溉组;p=0·89)或死亡率(无灌溉组295人中的18[6·1%]与灌溉组294人中的21[7·1%];p=58)。在符合方案分析中,主要意向治疗分析的结果没有实质性改变。不良事件的数量无显著组间差异,最常见的严重不良事件是全身感染(295名没有接受灌溉的参与者中有26[8·8%],294名接受灌溉的参与者中有22[7·5%]),颅内出血(13[4·4%]vs7[2·4%]),和癫痫发作(5[1·7%]对9[3·1%])。
结论:我们无法得出不灌溉的毛刺孔排水的非劣效性。不进行硬膜下冲洗的钻孔引流比硬膜下冲洗的再手术率高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膜下冲洗。
背景:大学健康研究国家基金(赫尔辛基大学医院),FinskaLäkaresällskapet,MedicinskaUnderstödsföreningenLivochHälsa,还有SvenskaKulturfonden.
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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%]).
CONCLUSIONS: 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.
BACKGROUND: State Fund for University Level Health Research (Helsinki University Hospital), Finska Läkaresällskapet, Medicinska Understödsföreningen Liv och Hälsa, and Svenska Kulturfonden.