| Objective Patients undergoing general anesthesia are prone to postoperative pulmonary complications(PPCs).This study was to investigate the impact of ERAS exercises standard training on recovery of pulmonary function of patients receiving laparoscopic colorectal surgery and formulate a perioperative ERAS exercises-ventilation strategy based on prediction of risk factors for PPCs,which may be applied for individualized regulation of perioperative pulmonary function of patients undergoing colorectal surgery and improving clinical outcomes..Methods The study protocol was registered at Chinese Clinical Trial Registry and approved by the Institutional Review Board of The First Affiliated Hospital of Chongqing Medical University and every center involved in this study.Informed consents were obtained from all enrolled patients.Part Ⅰ: A prospective,randomized controlled clinical trial was conducted in the First Affiliated Hospital of Chongqing Medical University from December 23,2020 to February 23,2021.Elderly patients receiving laparoscopic colorectal surgery were randomly assigned into ERAS exercises group(Group E)and Non-exercises group(Group N).Group E performed ERAS exercises from the day of admission to 90 days after surgery.Group N received perioperative standardized ERAS strategies without any ERAS exercises.Part Ⅱ: A single-center prospective,stratified randomized controlled study was conducted in the First Affiliated Hospital of Chongqing Medical University from March 1,2021 to June 1,2021.Patients receiving laparoscopic colorectal surgery were allocated into four groups according to the preoperative scores of ARISCAT and whether to carry out ERAS exercises or not: Low-risk of PPCs without exercises group(LN group),Low-risk of PPCs with ERAS exercises group(LE group),High-sisk of PPCs without exercises group(HN group)and High-sisk of PPCs with ERAS exercises group(HE group).ERAS exercises were not performed in the LN and HN groups before surgery,while it was performed in the LE and HE groups every morning and evening before surgery until discharge.Part Ⅲ: A multi-center prospective patient registrie-based cohort study was conducted in different medical institutions of Chongqing from June 1,2021 to November 1,2021.Patients were educated by ERAS exercises at the day of admission.An interview cohort was established for patients with ERAS exercises combined with perioperative lung protection strategies.ERAS exercise performance was scored on the day before surgery,the day of discharge,30 days after surgery and 90 days after surgery.According to the completion scores of ERAS exercises,patients were allocated into incomplete group,moderate-complete group and well-complete group.The primary endpoint was the incidence of postoperative pulmonary complications.The secondary outcomes included the incidence of surgery-related complications,6-minute walking distance(6MWD),Parameter of electrical impedance tomography(EIT)including global inhomogeneity index(GI);changes of end-expiratory lung impedance,(?EELI);tidal impedance variation(TIV),readmission rate for pulmonary disease within 90 days postoperatively,mortality on 30 and 90 days postoperatively,completion rate of ERAS exercises,health economics and scores of satisfaction for medical care.SPSS 23.0 software was used for statistical analysis.Descriptive analysis was performed on all variables.The measurement data followed a normal distribution(age,body mass index,oxygenation index,hospitalization costs,etc.)were presented as mean ± standard deviation(SD).The measurement data not subject to normal distribution(tumor stage,blood loss,postoperative hospital stay,etc.)were presented as median and range(quartile spacing).Enumeration data(preoperative complications,incidence of postoperative pulmonary complications,completion rate of ERAS exercises,etc.)were expressed as total size of sample and percentage.T-test was used for comparison between two independent sample groups conforming to normal distribution.Chi-square test was used to compare results for categorical variables.Fisher’s exact test was used for categorical variables when the number of event was less than 5.Two or more independent non-parametric samples were compared using Wilcoxon rank test or Kruskal-Wallis test.Repeated measures were analyzed using repeated measures of variance.Survival analysis were carried out for patients according to the rate of pulmonary disease readmission within 90 days after discharge.P<0.05 was considered as statistically significant difference.Results Part Ⅰ: 264 patients who met the inclusion criteria were randomly allocated to ERAS exercises group(Group E,n=132)or Non-exercises group(Group N,n=132).Five patients(including 3 in Group E and 2 in Group N)were lost to follow-up,with a loss rate of 1.8%.Finally,Group E(n =129)and Group N(n =130)completed this part of the study.There were no statistical differences of demographic characteristics between the two groups.A statistically significantly difference was observed for the incidence of postoperative pulmonary complications(13%vs.33%,P<0.001)and surgery-related complications(6% vs.28%,P<0.001)between Group E and Group N.On the day before surgery,the mean value of 6MWD improved in Group E compared with baseline(582.4±102.3vs.538.2±112.7,P<0.001).On 3 days after surgery,the mean value of6 MWD decreased in both groups when compared with baseline(P<0.001).On 30 days after surgery,the mean value of 6MWD in Group E increased when compared with the level of 3-day postoperatively(536.2±118.4vs.476.8±112.4,P<0.001).On 90 days after surgery,the mean value of6 MWD in Group E increased when compared with baseline(557.0±133.5vs.538.2±112.7,P<0.05),while that of Group N decreased from baseline(481.9±102.5 vs.535.1±123.4,P<0.001).Significant difference were found in value of 6MWD at different time points between the two groups(P<0.001).Compared with Group N,patients in Group E had shorter length of stay [5(IQR 4.5-6)vs.7.5(IQR 7-8),P<0.05] and lower hospitalization costs(8322±1277 vs.17654±3221,P<0.05).On 90 days after surgery,a statistically significantly difference was observed in the readmission rate for pulmonary disease of two groups(3.8% and 12.3% in Group E and Group N,respectively,P<0.05).Part Ⅱ: 216 patients who met the inclusion criteria were randomly assigned into low-risk of PPCs without exercise group(LN group,n=47),low-risk of PPCs with ERAS exercise group(LE group,n=47),high-sisk of PPCs without exercise group(HN group,n=61)and high-sisk of PPCs with ERAS exercise group(HE group,n=61).At the end of follow-up,2patients(including 1 in LN group and 1 in HN group)were lost to follow-up,with a loss rate of 0.9%.Finally,the LN group(n=46),LE group(n=47),HN group(n=60),and HE group(n=61)completed this part of the study.When compared with LN group,patients in HN group had higher incidence of PPCs(52% vs.15%,P<0.05),higher incidence of surgery-related complications(27% vs.17%,P<0.05),longer length of stay[9(IQR8-10)vs.8(IQR7-8),P<0.05] and higher hospitalization costs(89120±18064 vs.69862±13515,P<0.05).When compared with HN group,patients in HE group had lower incidence of PPCs(16% vs.52%,P<0.05),lower incidence of surgery-related complications(13% vs.27%,P<0.05),shorter length of stay [7(IQR6-8)vs.9(IQR8-10),P<0.05] and lower hospitalization costs(71846±14432 vs.89120±18064,P<0.05).Part Ⅲ: 2000 patients were enrolled and 1723 patients finished the study,the rate of lost to follow-up was 13.9%.Completion rate ERAS exercises were 100% on the day before surgery and the day of discharge respectively.On the 30 days after surgery,135 patients were lost to follow-up,with a loss rate of 6.75% and completion rate ERAS exercises was 94.7%.On the 90 days after surgery,277 patients were lost to follow-up,with a loss rate of 13.85% and completion rate ERAS exercises was74.7%.There were 117 patients with moderate completion of ERAS exercises during hospitalization,among which 33 cases developed PPCs with the incidence of 28%.While,there were 1883 patients with well completion of ERAS exercises,among which 273 patients developed PPCs with the incidence of 15%,the difference between the two groups was statistically significant(P<0.001).Among patients in the moderate-complete group,the incidence of PPCs were 18% for low-risk patients and 40% for high-risk patients(P<0.001).In the well-complete group,the incidence of PPCs were 14% for low-risk patients and 16% for high-risk patients(P>0.05).When comparing with incomplete and moderate-complete groups,the proportion of patients in well-complete group with postoperative hospital stay less than 5 days was significantly increased(35% vs.16%,P<0.05)and the incidence of those with in-hospital stay greater than 10 days was significantly decreased(14% vs.17%,P<0.05).The direct medical cost(62138±12687 vs.72312±14436,P<0.05),indirect medical cost [1200(IQR 800-1600)vs.2800(IQR1000-5000),P<0.05],total cost(66721±13268 vs.82311±14266,P<0.05),cost-effectiveness ratio(705 vs.890,P<0.05)and cost-utility ratio(102964±56437 vs.238582±96437,P<0.05)were significantly decreased in well-complete group when compared with moderate-complete group,while the scores of satisfaction was significantly increased(P<0.05).Conclusion(1)ERAS exercises could reduce the incidence of postoperative pulmonary complications,shorten the length of hospital stay,reduce hospitalization costs and improve functional ability and clinical prognosis in elderly patients undergoing laparoscopic colorectal surgery.(2)ERAS exercises could reduce the incidence of postoperative complications in patients with high-risk of PPCs undergoing laparoscopic colorectal surgery,it could also reduce postoperative hospital stay and hospitalization costs in high-risk patients to the level of those with low-risk of PPCs.(3)Standardized training of ERAS exercises could reduce the incidence of postoperative pulmonary complications in patients with high-risk of PPCs.Patients with well completion of ERAS exercises achieved higher satisfaction of medical care,better functional recovery after surgery at lower cost. |
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