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一种新型神经外科择期开颅手术后加速康复方案的安全性和有效性:一项前瞻性随机对照试验

Safety and efficacy of a novel neurosurgical enhanced recovery after surgery protocol for elective craniotomy: a prospective randomized controlled trial.

作者信息

Wang Yuan, Liu Bolin, Zhao Tianzhi, Zhao Binfang, Yu Daihua, Jiang Xue, Ye Lin, Zhao Lanfu, Lv Wenhai, Zhang Yufu, Zheng Tao, Xue Yafei, Chen Lei, Sankey Eric, Chen Long, Wu Yingxi, Li Mingjuan, Ma Lin, Li Zhengmin, Li Ruigang, Li Juan, Yan Jing, Wang Shasha, Zhao Hui, Sun Xude, Gao Guodong, Qu Yan, He Shiming

机构信息

Departments of1Neurosurgery.

2Anesthesiology, and.

出版信息

J Neurosurg. 2018 Jun 22;130(5):1680-1691. doi: 10.3171/2018.1.JNS171552. Print 2019 May 1.

DOI:10.3171/2018.1.JNS171552
PMID:29932379
Abstract

OBJECTIVE

Although enhanced recovery after surgery (ERAS) programs have gained acceptance in various surgical specialties, no established neurosurgical ERAS protocol for patients undergoing elective craniotomy has been reported in the literature. Here, the authors describe the design, implementation, safety, and efficacy of a novel neurosurgical ERAS protocol for elective craniotomy in a tertiary care medical center located in China.

METHODS

A multidisciplinary neurosurgical ERAS protocol for elective craniotomy was developed based on the best available evidence. A total of 140 patients undergoing elective craniotomy between October 2016 and May 2017 were enrolled in a randomized clinical trial comparing this novel protocol to conventional neurosurgical perioperative management. The primary endpoint of this study was the postoperative hospital length of stay (LOS). Postoperative morbidity, perioperative complications, postoperative pain scores, postoperative nausea and vomiting, duration of urinary catheterization, time to first solid meal, and patient satisfaction were secondary endpoints.

RESULTS

The median postoperative hospital LOS (4 days) was significantly shorter with the incorporation of the ERAS protocol than that with conventional perioperative management (7 days, p < 0.0001). No 30-day readmission or reoperation occurred in either group. More patients in the ERAS group reported mild pain (visual analog scale score 1-3) on postoperative day 1 than those in the control group (79% vs. 33%, OR 7.49, 95% CI 3.51-15.99, p < 0.0001). Similarly, more patients in the ERAS group had a shortened duration of pain (1-2 days; 53% vs. 17%, OR 0.64, 95% CI 0.29-1.37, p = 0.0001). The urinary catheter was removed within 6 hours after surgery in 74% patients in the ERAS group (OR 400.1, 95% CI 23.56-6796, p < 0.0001). The time to first oral liquid intake was a median of 8 hours in the ERAS group compared to 11 hours in the control group (p < 0.0001), and solid food intake occurred at a median of 24 hours in the ERAS group compared to 72 hours in the control group (p < 0.0001).

CONCLUSIONS

This multidisciplinary, evidence-based, neurosurgical ERAS protocol for elective craniotomy appears to have significant benefits over conventional perioperative management. Implementation of ERAS is associated with a significant reduction in the postoperative hospital stay and an acceleration in recovery, without increasing complication rates related to elective craniotomy. Further evaluation of this protocol in large multicenter studies is warranted.Clinical trial registration no.: ChiCTR-INR-16009662 (chictr.org.cn).

摘要

目的

尽管术后加速康复(ERAS)方案已在各种外科专业中得到认可,但文献中尚未报道针对接受择期开颅手术患者的成熟神经外科ERAS方案。在此,作者描述了中国一家三级医疗中心针对择期开颅手术的新型神经外科ERAS方案的设计、实施、安全性和有效性。

方法

基于现有最佳证据制定了针对择期开颅手术的多学科神经外科ERAS方案。2016年10月至2017年5月期间,共有140例接受择期开颅手术的患者被纳入一项随机临床试验,将该新型方案与传统神经外科围手术期管理进行比较。本研究的主要终点是术后住院时间(LOS)。术后发病率、围手术期并发症、术后疼痛评分、术后恶心呕吐、导尿持续时间、首次进食固体食物的时间以及患者满意度为次要终点。

结果

采用ERAS方案后的术后住院时间中位数(4天)明显短于传统围手术期管理(7天,p<0.0001)。两组均未发生30天再入院或再次手术。与对照组相比,ERAS组更多患者在术后第1天报告轻度疼痛(视觉模拟量表评分为1 - 3)(79%对33%,OR 7.49,95%CI 3.51 - 15.99,p<0.0001)。同样,ERAS组更多患者的疼痛持续时间缩短(1 - 2天;53%对17%,OR 0.64,95%CI 0.29 - 1.37,p = 0.0001)。ERAS组74%的患者在术后6小时内拔除导尿管(OR 400.1,95%CI 23.56 - 6796,p<0.0001)。ERAS组首次摄入口服液的时间中位数为8小时,而对照组为11小时(p<0.0001),ERAS组摄入固体食物的时间中位数为24小时,而对照组为72小时(p<0.0001)。

结论

这种针对择期开颅手术的多学科、基于证据的神经外科ERAS方案似乎比传统围手术期管理具有显著优势。实施ERAS与术后住院时间显著缩短和恢复加速相关,而不会增加与择期开颅手术相关的并发症发生率。有必要在大型多中心研究中对该方案进行进一步评估。临床试验注册号:ChiCTR-INR-16009662(chictr.org.cn)。

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