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开放肝切除术后强化康复与标准治疗的随机临床试验。

Randomized clinical trial on enhanced recovery versus standard care following open liver resection.

机构信息

Department of Anaesthesia, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.

出版信息

Br J Surg. 2013 Jul;100(8):1015-24. doi: 10.1002/bjs.9165. Epub 2013 May 21.

Abstract

BACKGROUND

Enhanced recovery programmes (ERPs) have been shown to reduce length of hospital stay (LOS) and complications in colorectal surgery. Whether ERPs have the same benefits in open liver resection surgery is unclear, and randomized clinical trials are lacking.

METHODS

Consecutive patients scheduled for open liver resection were randomized to an ERP group or standard care. Primary endpoints were time until medically fit for discharge (MFD) and LOS. Secondary endpoints were postoperative morbidity, pain scores, readmission rate, mortality, quality of life (QoL) and patient satisfaction. ERP elements included greater preoperative education, preoperative oral carbohydrate loading, postoperative goal-directed fluid therapy, early mobilization and physiotherapy. Both groups received standardized anaesthesia with epidural analgesia.

RESULTS

The analysis included 46 patients in the ERP group and 45 in the standard care group. Median MFD time was reduced in the ERP group (3 days versus 6 days with standard care; P < 0·001), as was LOS (4 days versus 7 days; P < 0·001). The ERP significantly reduced the rate of medical complications (7 versus 27 per cent; P = 0·020), but not surgical complications (15 versus 11 per cent; P = 0·612), readmissions (4 versus 0 per cent; P = 0·153) or mortality (both 2 per cent; P = 0·987). QoL over 28 days was significantly better in the ERP group (P = 0·002). There was no difference in patient satisfaction.

CONCLUSION

ERPs for open liver resection surgery are safe and effective. Patients treated in the ERP recovered faster, were discharged sooner, and had fewer medical-related complications and improved QoL.

REGISTRATION NUMBER

ISRCTN03274575 (http://www.controlled-trials.com).

摘要

背景

强化康复方案(ERPs)已被证明可减少结直肠手术的住院时间(LOS)和并发症。ERPs 对开放性肝切除术是否具有相同的益处尚不清楚,且缺乏随机临床试验。

方法

连续接受开放性肝切除术的患者被随机分配至 ERP 组或标准护理组。主要终点是达到适合出院的医学标准时间(MFD)和 LOS。次要终点是术后发病率、疼痛评分、再入院率、死亡率、生活质量(QoL)和患者满意度。ERP 要素包括术前强化教育、术前口服碳水化合物负荷、术后目标导向液体治疗、早期活动和物理治疗。两组均接受标准化麻醉联合硬膜外镇痛。

结果

分析纳入了 ERP 组 46 例和标准护理组 45 例患者。ERP 组 MFD 时间中位数更短(3 天比标准护理组 6 天;P<0·001), LOS 也更短(4 天比 7 天;P<0·001)。ERP 显著降低了医疗并发症发生率(7%比 27%;P=0·020),但未降低手术并发症发生率(15%比 11%;P=0·612)、再入院率(4%比 0%;P=0·153)或死亡率(均为 2%;P=0·987)。ERP 组在 28 天内 QoL 显著更好(P=0·002)。患者满意度无差异。

结论

开放性肝切除术的 ERPs 安全有效。接受 ERP 治疗的患者恢复更快,出院更早,且与医疗相关的并发症更少,生活质量改善。

注册号

ISRCTN03274575(http://www.controlled-trials.com)。

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