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颅骨钻孔引流慢性硬脑膜下血肿后骨膜下与硬膜下引流的随机临床试验(cSDH-Drain-Trial)。

Subperiosteal vs Subdural Drain After Burr-Hole Drainage of Chronic Subdural Hematoma: A Randomized Clinical Trial (cSDH-Drain-Trial).

机构信息

Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland.

Department of Neurosurgery, University Hospital of Basel, Basel, Switzerland.

出版信息

Neurosurgery. 2019 Nov 1;85(5):E825-E834. doi: 10.1093/neuros/nyz095.

Abstract

BACKGROUND

The use of a subdural drain (SDD) after burr-hole drainage of chronic subdural hematoma (cSDH) reduces recurrence at 6 mo. Subperiosteal drains (SPDs) are considered safer, since they are not positioned in direct contact to cortical structures, bridging veins, or hematoma membranes.

OBJECTIVE

To investigate whether the recurrence rate after insertion of a SPD is noninferior to the insertion of a more commonly used SDD.

METHODS

Multicenter, prospective, randomized, controlled, noninferiority trial analyzing patients undergoing burr-hole drainage for cSDH aged 18 yr and older. After hematoma evacuation, patients were randomly assigned to receive either a SDD (SDD-group) or a SPD (SPD-group). The primary endpoint was recurrence indicating a reoperation within 12 mo, with a noninferiority margin of 3.5%. Secondary outcomes included clinical and radiological outcome, morbidity and mortality rates, and length of stay.

RESULTS

Of 220 randomized patients, all were included in the final analysis (120 SPD and 100 SDD). Recurrence rate was lower in the SPD group (8.33%, 95% confidence interval [CI] 4.28-14.72) than in the SDD group (12.00%, 95% CI 6.66-19.73), with the treatment difference (3.67%, 95% CI -12.6-5.3) not meeting predefined noninferiority criteria. The SPD group showed significantly lower rates of surgical infections (P = .0406) and iatrogenic morbidity through drain placement (P = .0184). Length of stay and mortality rates were comparable in both groups.

CONCLUSION

Although the noninferiority criteria were not met, SPD insertion led to lower recurrence rates, fewer surgical infections, and lower drain misplacement rates. These findings suggest that SPD may be warranted in routine clinical practice.

摘要

背景

慢性硬脑膜下血肿(cSDH)颅骨钻孔引流后使用硬膜下引流(SDD)可降低 6 个月时的复发率。骨膜下引流(SPD)被认为更安全,因为它不直接放置在皮质结构、桥静脉或血肿膜上。

目的

研究 SPD 置入后复发率是否不劣于更常用的 SDD 置入。

方法

多中心、前瞻性、随机、对照、非劣效性试验,分析年龄在 18 岁及以上接受颅骨钻孔引流治疗 cSDH 的患者。血肿清除后,患者随机分为 SDD 组(SDD 组)或 SPD 组(SPD 组)。主要终点为 12 个月内需要再次手术的复发率,非劣效性边界为 3.5%。次要结局包括临床和影像学结局、发病率和死亡率以及住院时间。

结果

220 例随机患者均纳入最终分析(SPD 组 120 例,SDD 组 100 例)。SPD 组的复发率(8.33%,95%置信区间 [CI] 4.28-14.72)低于 SDD 组(12.00%,95% CI 6.66-19.73),治疗差异(3.67%,95% CI -12.6-5.3)未达到预设的非劣效性标准。SPD 组手术感染发生率(P=0.0406)和因引流管放置引起的医源性发病率(P=0.0184)明显较低。两组的住院时间和死亡率相当。

结论

尽管未达到非劣效性标准,但 SPD 置入可降低复发率、手术感染率和引流管错位率。这些发现表明 SPD 在常规临床实践中可能是合理的。

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