接受穿孔性腹膜炎急诊手术的患者中采用适应性 ERAS 路径与标准护理的比较：一项随机对照试验。
Adapted ERAS Pathway Versus Standard Care in Patients Undergoing Emergency Surgery for Perforation Peritonitis-a Randomized Controlled Trial.
机构信息
Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.
Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.
出版信息
J Gastrointest Surg. 2022 Jan;26(1):39-49. doi: 10.1007/s11605-021-05184-x. Epub 2021 Nov 9.
BACKGROUND
Enhanced Recovery After Surgery (ERAS) pathways have an uncertain role in emergencies. To the best of our knowledge, there are no trials studying ERAS in perforation peritonitis across the GI tract, despite it being a common surgical emergency.
AIMS
To evaluate the safety, feasibility and efficacy of adapted ERAS protocols in emergency laparotomy for perforation peritonitis.
METHODS
This was an open-labeled, superiority randomized controlled trial conducted between October 2018 and June 2020 in patients with perforation peritonitis assigned to standard care or adapted ERAS groups using block randomization. Patients with refractory shock, ASA class 4E, localized peritonitis, etc. were excluded. Components of the adapted ERAS protocol included epidural analgesia, goal-directed fluid therapy, avoidance of opioids, early mobilization, early removal of tubes, drains and catheters, and early enteral feeding. The primary outcome, length of hospitalization (LOH), and the secondary outcomes, functional recovery parameters, were analyzed between both the groups.
RESULTS
A total of 59 patients in standard care group and 61 patients in adapted ERAS group were included and randomized, and were comparable in terms of demographic and clinico-pathological characteristics. LOH in adapted ERAS group was shorter by 3 days (p < 0.001), and patients showed reduction in time (days) to first flatus (2.84 vs 4.22, p < 0.001), first stool (4.38 vs 6.08, p < 0.001) and solid diet (4.67 vs 8.37, p < 0.001). Post-operative nausea, vomiting (p = 0.05) and surgical site infections (p < 0.001) were reduced in adapted ERAS group. Pre-existing malignancy, respiratory complications and high output stoma were reasons for delayed discharge in adapted ERAS group.
CONCLUSION
Adapted ERAS pathways considerably reduce LOH in patients undergoing emergency surgery for perforation peritonitis, with no adverse events in 30 days after discharge.
TRIAL REGISTRATION
Registered at http://ctri.nic.in/Clinicaltrials/login.php (CTRI/2019/02/017537).
背景
加速康复外科（ERAS）方案在急诊中作用不确定。据我们所知，尽管穿孔性腹膜炎是一种常见的外科急症，但在整个胃肠道中，还没有研究 ERAS 方案的临床试验。
目的
评估改良 ERAS 方案在穿孔性腹膜炎急诊剖腹术中的安全性、可行性和疗效。
方法
这是一项于 2018 年 10 月至 2020 年 6 月期间进行的、开放性、优效性随机对照临床试验，将穿孔性腹膜炎患者分为接受标准治疗或改良 ERAS 组，采用区组随机分组。排除合并难治性休克、ASA 分级 4E 级、局限性腹膜炎等患者。改良 ERAS 方案的组成部分包括硬膜外镇痛、目标导向液体治疗、避免使用阿片类药物、早期活动、早期拔除引流管、导管和尿管以及早期肠内营养。主要结局为住院时间（LOH），次要结局为功能恢复参数，分析两组间的差异。
结果
标准治疗组 59 例患者和改良 ERAS 组 61 例患者纳入并随机分组，两组在人口统计学和临床病理特征方面具有可比性。改良 ERAS 组的 LOH 缩短了 3 天（p<0.001），患者首次排气（2.84 天 vs 4.22 天，p<0.001）、首次排便（4.38 天 vs 6.08 天，p<0.001）和开始固体饮食（4.67 天 vs 8.37 天，p<0.001）的时间均缩短。改良 ERAS 组术后恶心、呕吐（p=0.05）和手术部位感染（p<0.001）减少。改良 ERAS 组中，存在恶性肿瘤、呼吸并发症和高输出造口是延迟出院的原因。
结论
改良 ERAS 方案可显著缩短穿孔性腹膜炎患者急诊手术后的住院时间，且出院后 30 天内无不良事件发生。
试验注册
注册于 http://ctri.nic.in/Clinicaltrials/login.php（CTRI/2019/02/017537）。
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