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多模态加速康复外科(ERAS)方案是行完全腹腔镜远端胃癌根治术患者的最佳围手术期护理:一项前瞻性、随机、临床试验。

Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial.

机构信息

Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.

Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Ann Surg Oncol. 2018 Oct;25(11):3231-3238. doi: 10.1245/s10434-018-6625-0. Epub 2018 Jul 26.

Abstract

BACKGROUND

The application of ERAS protocol has widely gained acceptance after gastrointestinal surgery. Well-designed, randomized, control trials are needed to evaluate fully its safety and efficacy in the field of gastric cancer. This study aims to compare the enhanced recovery after surgery (ERAS) protocol and the conventional perioperative care program after totally laparoscopic distal gastrectomy (TLDG) in gastric cancer.

METHODS

Patients with gastric cancer indicated for TLDG were randomly assigned to either the ERAS group or the conventional group. The ERAS protocol included short fasting time, fluid restriction, early oral feeding, immediate mobilization, and use of epidural patient-controlled analgesia. Primary endpoint was recovery time, which was defined with the criteria of tolerable diet, safe ambulation, no requirement of additional analgesics, and afebrile state. Hospital stay, pain score, complications, and readmission rate were secondary endpoints.

RESULTS

A total of 97 patients who underwent TLDG from October 2012 to August 2014 were enrolled (ERAS = 46, conventional = 51). The ERAS group had faster recovery time (111.6 ± 34.3 vs. 126.7 ± 30.7 h; p = 0.026) and significantly less pain through postoperative days 1-4. Possible hospital stay also was faster in the ERAS group (5.0 ± 1.9 vs. 5.7 ± 1.6 days, p = 0.038), but there was no difference in actual hospital stay. No difference was found in complication, and there was no mortality or readmission in both groups.

CONCLUSIONS

ERAS is safe and enhances postoperative recovery after TLDG in gastric cancer.

TRIAL REGISTRATION

The trial was registered in ClinicalTrials.gov (NCT01938313).

摘要

背景

胃肠道手术后,加速康复外科(ERAS)方案得到了广泛认可。需要设计良好的随机对照试验来全面评估其在胃癌领域的安全性和疗效。本研究旨在比较胃癌全腹腔镜远端胃切除术(TLDG)后的增强康复外科(ERAS)方案和常规围手术期护理方案。

方法

将接受 TLDG 的胃癌患者随机分为 ERAS 组或常规组。ERAS 方案包括短时间禁食、限制液体摄入、早期口服喂养、早期活动以及硬膜外自控镇痛。主要终点是恢复时间,定义为耐受饮食、安全活动、无需额外镇痛和无发热状态。次要终点为住院时间、疼痛评分、并发症和再入院率。

结果

共纳入 2012 年 10 月至 2014 年 8 月期间接受 TLDG 的 97 例患者(ERAS 组 46 例,常规组 51 例)。ERAS 组恢复时间更快(111.6±34.3 比 126.7±30.7 小时;p=0.026),术后第 1-4 天疼痛评分更低。ERAS 组可能的住院时间也更快(5.0±1.9 比 5.7±1.6 天,p=0.038),但实际住院时间无差异。两组并发症无差异,均无死亡或再入院。

结论

ERAS 是安全的,可促进胃癌 TLDG 后的术后恢复。

试验注册

本试验在 ClinicalTrials.gov 注册(NCT01938313)。

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