加速康复外科在腹腔镜胃癌手术围手术期应用安全性与有效性的临床研究
发布时间：2018-09-04 16:07
【摘要】：加速康复外科(enhanced recovery after surgery,ERAS)其旨在于通过采取一系列有循证医学证据的围手术期优化处理措施,以减轻创伤应激、减少术后并发症,加速患者康复。胃癌是中国癌症死亡的第二大原因。手术是最主要的治疗手段。腹腔镜手术具有缩短住院天数,加速术后康复优势。ERAS应用于腹腔镜胃癌根治术围手术期,能否进一步扩大优势,实现更快的康复,尚缺乏高级别循证医学证据支持。因此,本论文将分三章节评估ERAS理念在腹腔镜胃癌根治术围手术期应用的安全性及有效性,提供高级别的循证医学证据。第一章为概括ERAS在胃癌手术应用的研究进展,分别就营养支持、代谢调整、液体治疗、疼痛管理及效果评价这些有争议或者受关注措施进行研究概述。ERAS在胃癌手术的应用和研究目前尚处于起步阶段,未来需要高质量临床研究来完善循证医学证据。第二章为ERAS与传统康复在腹腔镜胃癌手术应用的回顾性多中心对照临床研究。方法:选自中国腹腔镜胃肠外科研究组(CLASS)数据库中2007年1月到2009年12月884例全国多中心的择期腹腔镜胃癌手术病人的临床数据。进行倾向性评分匹配后,加速康复组和传统康复组各94例。结果:加速康复组病人在首次恢复排气、首次离床活动、拔除引流管、恢复全流饮食和恢复半流饮食等临床恢复指标均比传统康复组明显提前,差异有统计学意义(P0.001)。加速康复组术后住院天数约为7.6天,比传统康复组14.8天减少约一半,差异有统计学意义(P0.001)。加速康复组术后并发症发生率为15%,传统康复组术后并发症发生率为17%,两组差异无统计学意义(P=0.84)。加速康复组Ⅰ级并发症10例,Ⅱ级或Ⅱ级以上并发症2例;传统康复组Ⅰ级并发症0例,Ⅱ级或Ⅱ级以上并发症11例,两组差异有统计学差异(P0.001)。结论:本研究结果可初步证实加速康复外科在腹腔镜胃癌手术围手术期的应用具有缩短术后住院天数,加速患者临床康复,减轻患者术后并发症严重程度的作用。第三章为ERAS在腹腔镜远端胃癌根治术围手术期的应用:一项前瞻性单臂临床研究方案。研究人群:18岁到75岁病理确诊胃腺癌,术前临床分期为T1-4a,N0-3,M0,预计可行腹腔镜远端胃癌根治术,无严重心肝肺肾脏器功能障碍,ECOG体力状态评分0/1,ASA评分Ⅰ-Ⅱ。干预措施:围手术期均采用加速康复处理。研究设计:前瞻性、单中心、单臂研究。样本量:128人。主要研究终点:术后实际住院天数、术后4天康复率。次要研究终点:30天内再返院率、术后早期并发症、住院费用、术后疼痛评分、术后恢复指标、术后炎症免疫反应、EORTC QLQ-STO 22生命质量测定表、术后6 min步行试验(6MWT),患者对ERAS各项措施的依从性。
[Abstract]:Accelerated Rehabilitation surgery (enhanced recovery after surgery,ERAS) aims at reducing trauma stress, reducing postoperative complications and accelerating patients' recovery by adopting a series of evidence-based medical evidence to optimize perioperative management. Gastric cancer is the second leading cause of cancer deaths in China. Surgery is the main treatment. Laparoscopic surgery has the advantages of shortening hospital stay and accelerating postoperative rehabilitation. ERAs can be used in the perioperative period of laparoscopic radical gastrectomy for gastric cancer. Whether the advantage can be further expanded and faster recovery can be achieved, there is still a lack of high level evidence-based medical evidence to support it. Therefore, this paper will be divided into three chapters to evaluate the safety and efficacy of ERAS in the perioperative period of laparoscopic radical gastrectomy for gastric cancer, and provide high level evidence-based medical evidence. The first chapter summarizes the research progress in the application of ERAS in gastric cancer surgery, including nutrition support, metabolic adjustment, fluid therapy. The application and research of ERAs in gastric cancer surgery is still in its infancy. High quality clinical research is needed to perfect the evidence of evidence-based medicine in the future. The second chapter is a retrospective multicenter controlled clinical study of ERAS and traditional rehabilitation in laparoscopic gastric cancer surgery. Methods: the clinical data of 884 patients undergoing elective laparoscopic gastric cancer surgery from January 2007 to December 2009 were collected from the (CLASS) database of Chinese Laparoscopic Gastrointestinal surgery Group. After orientation score matching, 94 cases in accelerated rehabilitation group and 94 cases in traditional rehabilitation group. Results: the clinical recovery indexes of patients in accelerated rehabilitation group were significantly earlier than those in the traditional rehabilitation group (P0.001), such as the first recovery of exhaust, the first movement out of bed, the removal of drainage tube, the recovery of whole stream diet and the recovery of half stream diet (P0.001). The postoperative hospitalization days in the accelerated rehabilitation group were 7.6 days, which was about half of the 14.8 days in the traditional rehabilitation group. The difference was statistically significant (P0.001). The incidence of postoperative complications in the accelerated rehabilitation group was 15 and that in the traditional rehabilitation group was 17. There was no significant difference between the two groups (P < 0. 84). There were 10 cases of grade 鈪，
本文编号：2222671
[Abstract]:Accelerated Rehabilitation surgery (enhanced recovery after surgery,ERAS) aims at reducing trauma stress, reducing postoperative complications and accelerating patients' recovery by adopting a series of evidence-based medical evidence to optimize perioperative management. Gastric cancer is the second leading cause of cancer deaths in China. Surgery is the main treatment. Laparoscopic surgery has the advantages of shortening hospital stay and accelerating postoperative rehabilitation. ERAs can be used in the perioperative period of laparoscopic radical gastrectomy for gastric cancer. Whether the advantage can be further expanded and faster recovery can be achieved, there is still a lack of high level evidence-based medical evidence to support it. Therefore, this paper will be divided into three chapters to evaluate the safety and efficacy of ERAS in the perioperative period of laparoscopic radical gastrectomy for gastric cancer, and provide high level evidence-based medical evidence. The first chapter summarizes the research progress in the application of ERAS in gastric cancer surgery, including nutrition support, metabolic adjustment, fluid therapy. The application and research of ERAs in gastric cancer surgery is still in its infancy. High quality clinical research is needed to perfect the evidence of evidence-based medicine in the future. The second chapter is a retrospective multicenter controlled clinical study of ERAS and traditional rehabilitation in laparoscopic gastric cancer surgery. Methods: the clinical data of 884 patients undergoing elective laparoscopic gastric cancer surgery from January 2007 to December 2009 were collected from the (CLASS) database of Chinese Laparoscopic Gastrointestinal surgery Group. After orientation score matching, 94 cases in accelerated rehabilitation group and 94 cases in traditional rehabilitation group. Results: the clinical recovery indexes of patients in accelerated rehabilitation group were significantly earlier than those in the traditional rehabilitation group (P0.001), such as the first recovery of exhaust, the first movement out of bed, the removal of drainage tube, the recovery of whole stream diet and the recovery of half stream diet (P0.001). The postoperative hospitalization days in the accelerated rehabilitation group were 7.6 days, which was about half of the 14.8 days in the traditional rehabilitation group. The difference was statistically significant (P0.001). The incidence of postoperative complications in the accelerated rehabilitation group was 15 and that in the traditional rehabilitation group was 17. There was no significant difference between the two groups (P < 0. 84). There were 10 cases of grade 鈪，
本文编号：2222671
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