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Safety And Efficacy Of Enhanced Revovery After Surgery(ERAS)Protocol In Laparoscopic Gastrectomy For Gastric Cancer:a Clinical Trial

Posted on:2018-03-18Degree:MasterType:Thesis
Country:ChinaCandidate:Y ZhuFull Text:PDF
GTID:2334330518967610Subject:Surgery
Abstract/Summary:PDF Full Text Request
The enhanced recovery after surgery(ERAS)applies a series of evidence-based perioperative measures to reduce postoperative complications and accelerate patients'recovery,by relieving both physical and mental stress caused by surgical operation.Gastric cancer is the third leading cause of cancer deaths in China.Surgery is the main treatment.Laparoscopic approach has been confirmed in benefit of shortening hospital stay and accelerating postoperative rehabilitation.There is no high-level evidence-based medical evidence in favor of ERAS plus laparoscopic gastrectomy for gastric cancer can further expand the advantage.Therefore,the aim of the paper was to investigate the safety and efficacy of ERAS in peri-operative application of laparoscopic gastrectomy for gastric cancer.This paper consists of three parts,the details are as follows:Chapter I:Review of ERAS in gastric cancer surgery.Focus on the research progress of the controversial or popular measures,such as nutritional support,metabolic adjustments,fluid therapy,pain management.effect evaluation and so on.ERAS application in gastric cancer surgery is still in the early stage.It is need to conduct highly quality clinical trials to povide more medical evidences.Chapter ?:Enhanced Recovery after Surgery Protocol versus Conventional Care in Laparoscopic Gastrectomy:Results from the Chinese Laparoscopic Gastrointestinal Surgery Study(CLASS)Group.Background:Laparoscopic gastrectomy(LAG)has gained popularity in the treatment of gastric cancer.There were few literatures reporting the safety and efficacy of the enhanced recovery after surgery(ERAS)program for laparoscopic gastrectomy.The present study aimed to evaluate the efficacy and safety of the ERAS program in LAG using the database from the Chinese Laparoscopic Gastrointestinal Surgery Study(CLASS)group in a propensity score-matched(PSM)design.Methods:A consecutive series of 884 gastric cancer patients with clinical stage T1-4aN0-3M0 underwent LAG between January 2007 and December 2009 was identified from the CLASS database.Based on the PSM analysis,the patients were grouped into the ERAS group(n=94)and the conventional group(CONV,n=94).The hospital stay,incidence of postoperative complications and clinical outcomes between the groups were compared.Results:Compared to the CONV group,the ERAS group showed faster recovery with distinctly shorter length of postoperative hospital stay(7.6 vs.14.8 days,p<0.001).There was also significant difference in clinical outcome.The postoperative morbidity was 15%in the ERAS group and 17%in CONV groupwithout a significant difference(P=0.857),however,the ERAS group has less severe complications than the CONV group(10 cases in grade ? and no case in grade ? for ERAS group,no case in grade I and 10 cases in grade II for CONV group,P<0.001).Conclusion:The ERAS program plus LAG seemed safe and effective in gastric cancer patients and may further accelerate rehabilitation accordingly.Chapter III:Efficacy of Enhanced Recovery after Surgery(ERAS)on Laparoscopic Distal Gastrectomy for gastric cancer:study protocol for a prospective single arm trial.Participants:All consecutive patients scheduled for elective laparoscopic distal gastrectomy were identified as potential subjects from November 2016 in Nanfang Hospital of Southern Medical University.Inclusion criteria as follow:18 years<age<75 years,primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy,cTl-4a,N0-3,M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition,expected radical resection through laparoscopic distal gastrectomy,no severe organ dysfunction,performance status of 0 or 1 on ECOG scale,informed consent.Design:a prospective single arm trial in single centre.Interventions:All subjects will undergo LADG with a perioperative management of ERAS program.Sample size:128.Primary endpoint:postoperative hospital stay,recovery rate of postoperative 4th day.Secondary endpoints:early postoperative complication,postoperative recovery(time to first ambulation,flatus,liquid diet and soft diet),pain intensity,operative outcomes,postoperative inflammatory immune response,EORTC QLQ-STO 22.6 min walk test(6MWT),the compliance of ERAS protocol.
Keywords/Search Tags:Enhanced Recovery after Surgery(ERAS), safety, efficacy, laparoscopic gastrectomy, gastric cancer
PDF Full Text Request
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