Peng Jin, Dong Ruiying, Jiao Jianfen, Liu Min, Zhang Xi, Bu Hualei, Dong Ping, Zhao Shasha, Xing Naidong, Feng Shuai, Yang Xingsheng, Kong Beihua
Department of Obstetrics and Gynecology, Qilu hospital, Cheeloo College of Medicine, Shandong University, Jinan, People's Republic of China.
Department of Anesthesiology, Qilu Hospital, Shandong University, Jinan, People's Republic of China.
Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021.
Enhanced recovery after surgery (ERAS) protocol has widely gained acceptance in gynecological surgery. Its safety and efficacy should be evaluated fully via well-designed, randomized, control trials. The main objective of our study is to compare the ERAS protocol with the conventional perioperative care program after gynecological oncology. Furthermore, the secondary objectives of our study are the identification of markers that allow us to evaluate the effectiveness of the application of ERAS elements in the modulation of the body's response to surgical stress.
Patients with gynecological tumors indicated for surgery were randomly assigned to either the ERAS group or the conventional group. The ERAS protocol included short fasting time, fluid restriction, early oral feeding, reduced opioid consumption and immediate mobilization after surgery. The primary endpoint was the reduction of hospital stay in the ERAS group. The day of first flatus, postoperative nausea and vomiting (PONV), maximum pain score by the visual analogue scale (VAS) and complication, readmission rate, reoperation rate, postoperative mortality, total hospital cost and systemic inflammatory response (SIR) were secondary endpoints.
A total of 130 patients in gynecological tumor surgery were enrolled (ERAS = 65, conventional = 65). The ERAS group had faster bowel function recovery, significantly less pain, less PONV, shorter hospital stay, and less total hospital costs. SIR markers were estimated and screened out that postoperative platelet, neutrophil-lymphocyte-ratio (NLR) and platelet-lymphocyte-ratio (PLR) were significantly lower in ERAS groups compared to conventional groups.
The implementation of ERAS protocol is safe and enhances postoperative recovery after gynecological oncology surgery. We firstly reveal the beneficial effect of ERAS protocols on the alleviation of postoperative SIR, which is a reflection of the magnitude of surgical trauma. Postoperative platelet, NLR or PLR could be the novel and inexpensive markers to assess how ERAS protocols modulate gynecological oncology surgery.
The trial was registered in ClinicalTrials.gov (NCT03629626).
术后加速康复(ERAS)方案在妇科手术中已广泛获得认可。其安全性和有效性应通过精心设计的随机对照试验进行全面评估。我们研究的主要目的是比较妇科肿瘤手术后ERAS方案与传统围手术期护理方案。此外,我们研究的次要目的是确定能够让我们评估ERAS要素在调节机体对手术应激反应中的应用效果的标志物。
拟行手术的妇科肿瘤患者被随机分为ERAS组或传统组。ERAS方案包括缩短禁食时间、限制液体摄入、早期经口进食、减少阿片类药物使用以及术后立即活动。主要终点是ERAS组住院时间的缩短。首次排气时间、术后恶心呕吐(PONV)、视觉模拟量表(VAS)的最大疼痛评分以及并发症、再入院率、再次手术率、术后死亡率、总住院费用和全身炎症反应(SIR)为次要终点。
共有130例妇科肿瘤手术患者入组(ERAS组 = 65例,传统组 = 65例)。ERAS组肠道功能恢复更快,疼痛明显减轻,PONV更少,住院时间更短,总住院费用更低。对SIR标志物进行了评估并筛选出,与传统组相比,ERAS组术后血小板、中性粒细胞 - 淋巴细胞比值(NLR)和血小板 - 淋巴细胞比值(PLR)显著更低。
ERAS方案的实施是安全的,并可促进妇科肿瘤手术后的恢复。我们首次揭示了ERAS方案对减轻术后SIR的有益作用,这反映了手术创伤的程度。术后血小板、NLR或PLR可能是评估ERAS方案如何调节妇科肿瘤手术的新型且廉价的标志物。
该试验已在ClinicalTrials.gov(NCT03629626)注册。