加速康復外科在腹腔鏡胃癌手術圍手術期應用安全性與有效性的臨床研究
發(fā)布時間：2018-09-04 16:07
【摘要】：加速康復外科(enhanced recovery after surgery,ERAS)其旨在于通過采取一系列有循證醫(yī)學證據(jù)的圍手術期優(yōu)化處理措施,以減輕創(chuàng)傷應激、減少術后并發(fā)癥,加速患者康復。胃癌是中國癌癥死亡的第二大原因。手術是最主要的治療手段。腹腔鏡手術具有縮短住院天數(shù),加速術后康復優(yōu)勢。ERAS應用于腹腔鏡胃癌根治術圍手術期,能否進一步擴大優(yōu)勢,實現(xiàn)更快的康復,尚缺乏高級別循證醫(yī)學證據(jù)支持。因此,本論文將分三章節(jié)評估ERAS理念在腹腔鏡胃癌根治術圍手術期應用的安全性及有效性,提供高級別的循證醫(yī)學證據(jù)。第一章為概括ERAS在胃癌手術應用的研究進展,分別就營養(yǎng)支持、代謝調(diào)整、液體治療、疼痛管理及效果評價這些有爭議或者受關注措施進行研究概述。ERAS在胃癌手術的應用和研究目前尚處于起步階段,未來需要高質(zhì)量臨床研究來完善循證醫(yī)學證據(jù)。第二章為ERAS與傳統(tǒng)康復在腹腔鏡胃癌手術應用的回顧性多中心對照臨床研究。方法:選自中國腹腔鏡胃腸外科研究組(CLASS)數(shù)據(jù)庫中2007年1月到2009年12月884例全國多中心的擇期腹腔鏡胃癌手術病人的臨床數(shù)據(jù)。進行傾向性評分匹配后,加速康復組和傳統(tǒng)康復組各94例。結果:加速康復組病人在首次恢復排氣、首次離床活動、拔除引流管、恢復全流飲食和恢復半流飲食等臨床恢復指標均比傳統(tǒng)康復組明顯提前,差異有統(tǒng)計學意義(P0.001)。加速康復組術后住院天數(shù)約為7.6天,比傳統(tǒng)康復組14.8天減少約一半,差異有統(tǒng)計學意義(P0.001)。加速康復組術后并發(fā)癥發(fā)生率為15%,傳統(tǒng)康復組術后并發(fā)癥發(fā)生率為17%,兩組差異無統(tǒng)計學意義(P=0.84)。加速康復組Ⅰ級并發(fā)癥10例,Ⅱ級或Ⅱ級以上并發(fā)癥2例;傳統(tǒng)康復組Ⅰ級并發(fā)癥0例,Ⅱ級或Ⅱ級以上并發(fā)癥11例,兩組差異有統(tǒng)計學差異(P0.001)。結論:本研究結果可初步證實加速康復外科在腹腔鏡胃癌手術圍手術期的應用具有縮短術后住院天數(shù),加速患者臨床康復,減輕患者術后并發(fā)癥嚴重程度的作用。第三章為ERAS在腹腔鏡遠端胃癌根治術圍手術期的應用:一項前瞻性單臂臨床研究方案。研究人群:18歲到75歲病理確診胃腺癌,術前臨床分期為T1-4a,N0-3,M0,預計可行腹腔鏡遠端胃癌根治術,無嚴重心肝肺腎臟器功能障礙,ECOG體力狀態(tài)評分0/1,ASA評分Ⅰ-Ⅱ。干預措施:圍手術期均采用加速康復處理。研究設計:前瞻性、單中心、單臂研究。樣本量:128人。主要研究終點:術后實際住院天數(shù)、術后4天康復率。次要研究終點:30天內(nèi)再返院率、術后早期并發(fā)癥、住院費用、術后疼痛評分、術后恢復指標、術后炎癥免疫反應、EORTC QLQ-STO 22生命質(zhì)量測定表、術后6 min步行試驗(6MWT),患者對ERAS各項措施的依從性。
[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，
本文編號：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，
本文編號：2222671
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