Jensen Thorbjørn Søren Rønn, Haldrup Mette, Hjortdal Grønhøj Mads, Miscov Rares, Larsen Carl Christian, Debrabant Birgit, Poulsen Frantz Rom, Bergholt Bo, Hundsholt Torben, Bjarkam Carsten Reidies, Fugleholm Kåre
1Department of Neurosurgery, Rigshospitalet, Copenhagen, Denmark.
3Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
J Neurosurg. 2021 Dec 31;137(3):799-806. doi: 10.3171/2021.10.JNS211608. Print 2022 Sep 1.
Placement of a subdural drain reduces recurrence and death after evacuation of chronic subdural hematoma (CSDH), but little is known about optimal drainage duration. In the present national trial, the authors investigated the effect of drainage duration on recurrence and death.
In a randomized controlled trial involving all neurosurgical departments in Denmark, patients treated with single burr hole evacuation of CSDH were randomly assigned to 24 hours or 48 hours of postoperative passive subdural drainage. Follow-up duration was 90 days, and the primary study outcome was recurrent hematoma requiring reoperation. Secondary outcome was death. In addition, complications and length of hospital stay were recorded and analyzed.
Of the 420 included patients, 212 were assigned 24-hour drainage and 208 were assigned 48-hour drainage. The recurrence rate was 14% in the 24-hour group and 13% in the 48-hour group. Four patients died in the 24-hour group, and 8 patients died in the 48-hour group; this difference was not statistically significant. The ORs (95% CIs) for recurrence and mortality (48 hours vs 24 hours) were 0.94 (0.53-1.66) and 2.07 (0.64-7.85), respectively, in the intention-to-treat analysis. The ORs (95% CIs) for recurrence and mortality per 1-hour increase in drainage time were 1.0005 (0.9770-1.0244) and 1.0046 (0.9564-1.0554), respectively, in the as-treated sensitivity analysis that used the observed drainage times instead of the preassigned treatment groups. The rates of surgical and drain-related complications, postoperative infections, and thromboembolic events were not different between groups. The mean ± SD postoperative length of hospital stay was 7.4 ± 4.3 days for patients who received 24-hour drainage versus 8.4 ± 4.9 days for those who received 48-hour drainage (p = 0.14). The mean ± SD postoperative length of stay in the neurosurgical department was significantly shorter for the 24-hour group (2 ± 0.9 days vs 2.8 ± 1.6 days, p < 0.001).
No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.
放置硬膜下引流管可降低慢性硬膜下血肿（CSDH）引流术后的复发率和死亡率，但对于最佳引流持续时间知之甚少。在本次全国性试验中，作者研究了引流持续时间对复发率和死亡率的影响。
在一项涉及丹麦所有神经外科科室的随机对照试验中，接受单孔钻颅引流CSDH治疗的患者被随机分配至术后24小时或48小时的被动硬膜下引流。随访期为90天，主要研究结局为需要再次手术的复发性血肿。次要结局为死亡。此外，记录并分析并发症和住院时间。
420例纳入患者中，212例被分配至24小时引流组，208例被分配至48小时引流组。24小时组的复发率为14%，48小时组为13%。24小时组有4例患者死亡，48小时组有8例患者死亡；差异无统计学意义。在意向性分析中，复发和死亡的比值比（95%可信区间）（48小时 vs 24小时）分别为0.94（0.53 - 1.66）和2.07（0.64 - 7.85）。在使用观察到的引流时间而非预先指定的治疗组的实际治疗敏感性分析中，每增加1小时引流时间，复发和死亡的比值比（95%可信区间）分别为1.0005（0.9770 - 1.0244）和1.0046（0.9564 - 1.0554）。两组之间手术及与引流相关的并发症、术后感染和血栓栓塞事件的发生率无差异。接受24小时引流的患者术后平均住院时间±标准差为7.4 ± 4.3天，而接受48小时引流的患者为8.4 ± 4.9天（p = 0.14）。24小时组在神经外科的术后平均住院时间±标准差显著更短（2 ± 0.9天 vs 2.8 ± 1.6天，p < 0.001）。
在CSDH钻孔引流术后随机接受24小时或48小时被动硬膜下引流的两组患者中，90天随访期间复发性血肿或死亡率无显著差异。
