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Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:With the substantially growing trend of the aging populations in China and the rest of the world, the number of total hip and total knee arthroplasty (THA and TKA) cases are increasing dramatically. It is important to develop practical strategies to improve the quality of healthcare and better outcome for patients undergoing THA and TKA. Enhanced recovery after surgery (ERAS) pathways have been reported to promote earlier recovery and be beneficial for patients. We propose the hypothesis that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients undergoing primary THA or TKA. METHODS/DESIGN:This trial is a prospective, open-labelled, multi-centered, randomized controlled trial that will test the superiority of the ERAS pathway in term of LOS in hospital for the patients undergoing primary THA or TKA compared to current non-ERAS clinical practice. A total of 640 patients undergoing primary THA or TKA will be randomly allocated to either ERAS pathway (ERAS group) or conventional care according to individual participating center (non-ERAS group). The primary outcome is the total LOS in hospital; the secondary outcomes include postoperative LOS, all-cause mortality by 30?days after operation, in-hospital complications, early mobilization, postoperative pain control, total in-hospital cost, and readmission rate by 30?days after discharge from the hospital. DISCUSSION:This trial is designed to evaluate the superiority of the ERAS pathway to conventional non-ERAS clinical practice in reducing the LOS. The results may provide new insight into the clinical applications of the ERAS pathway for THA and TKA. TRIAL REGISTRATION:National Institutes of Health Clinical Trials Registry, NCT03517098 . Registered on 4 May 2018.

SUBMITTER: Li J

PROVIDER: S-EPMC6805414 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial.

Li Jingyi J Zhu Haibei H Liao Ren R

Trials 20191022 1

<h4>Background</h4>With the substantially growing trend of the aging populations in China and the rest of the world, the number of total hip and total knee arthroplasty (THA and TKA) cases are increasing dramatically. It is important to develop practical strategies to improve the quality of healthcare and better outcome for patients undergoing THA and TKA. Enhanced recovery after surgery (ERAS) pathways have been reported to promote earlier recovery and be beneficial for patients. We propose the ...[more]

PMID: 31640757

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Project description:ImportanceThe Enhanced Recovery After Surgery (ERAS) care protocol has been shown to improve outcomes compared with traditional care in certain types of surgery.ObjectiveTo assess the association of use of the ERAS protocols with complications in patients undergoing elective total hip arthroplasty (THA) and total knee arthroplasty (TKA).Design, setting, and participantsThis multicenter, prospective cohort study included patients recruited from 131 centers in Spain from October 22 through December 22, 2018. All consecutive adults scheduled for elective THA or TKA were eligible for inclusion. Patients were stratified between those treated in a self-designated ERAS center (ERAS group) and those treated in a non-ERAS center (non-ERAS group). Data were analyzed from June 15 through September 15, 2019.ExposuresTotal hip or knee arthroplasty and perioperative management. Sixteen individual ERAS items were assessed in all included patients, whether they were treated at a center that was part of an established ERAS protocol or not.Main outcomes and measuresThe primary outcome was postoperative complications within 30 days after surgery. Secondary outcomes included length of stay and mortality.ResultsDuring the 2-month recruitment period, 6146 patients were included (3580 women [58.2%]; median age, 71 [interquartile range (IQR), 63-76] years). Of these, 680 patients (11.1%) presented with postoperative complications. No differences were found in the number of patients with overall postoperative complications between ERAS and non-ERAS groups (163 [10.2%] vs 517 [11.4%]; odds ratio [OR], 0.89; 95% CI, 0.74-1.07; P?=?.22). Fewer patients in the ERAS group had moderate to severe complications (73 [4.6%] vs 279 [6.1%]; OR, 0.74; 95% CI, 0.56-0.96; P?=?.02). The median overall adherence rate with the ERAS protocol was 50.0% (IQR, 43.8%-62.5%), with the rate for ERAS facilities being 68.8% (IQR, 56.2%-81.2%) vs 50.0% (IQR, 37.5%-56.2%) at non-ERAS centers (P?<?.001). Among the patients with the highest and lowest quartiles of adherence to ERAS components, the patients with the highest adherence had fewer overall postoperative complications (144 [10.6%] vs 270 [13.0%]; OR, 0.80; 95% CI, 0.64-0.99; P?<?.001) and moderate to severe postoperative complications (59 [4.4%] vs 143 [6.9%]; OR, 0.62; 95% CI, 0.45-0.84; P?<?.001) and shorter median length of hospital stay (4 [IQR, 3-5] vs 5 [IQR, 4-6] days; OR, 0.97; 95% CI, 0.96-0.99; P?<?.001).Conclusions and relevanceAn increase in adherence to the ERAS program was associated with a decrease in postoperative complications, although only a few ERAS items were individually associated with improved outcomes.

Project description:OBJECTIVES:To assess cost-effectiveness of enhanced recovery pathways following total hip and knee arthroplasties. Secondary objectives were to report on quality of studies and identify research gaps for future work. DESIGN:Systematic review of cost-utility analyses. DATA SOURCES:Ovid MEDLINE, Embase, the National Health Service Economic Evaluations Database and EconLit, January 2000 to August 2019. ELIGIBILITY CRITERIA:English-language peer-reviewed cost-utility analyses of enhanced recovery pathways, or components of one, compared with usual care, in patients having total hip or knee arthroplasties for osteoarthritis. DATA EXTRACTION AND SYNTHESIS:Data extracted by three reviewers with disagreements resolved by a fourth. Study quality assessed using the Consensus on Health Economic Criteria list, the International Society for Pharmacoeconomics and Outcomes Research and Assessment of the Validation Status of Health-Economic decision models tools; for trial-based studies the Cochrane Collaboration's tool to assess risk of bias. No quantitative synthesis was undertaken. RESULTS:We identified 17 studies: five trial-based and 12 model-based studies. Two analyses evaluated entire enhanced recovery pathways and reported them to be cost-effective compared with usual care. Ten pathway components were more effective and cost-saving compared with usual care, three were cost-effective, and two were not cost-effective. We had concerns around risk of bias for all included studies, particularly regarding the short time horizon of the trials and lack of reporting of model validation. CONCLUSIONS:Consistent results supported enhanced recovery pathways as a whole, prophylactic systemic antibiotics, antibiotic-impregnated cement and conventional ventilation for infection prevention. No other interventions were subject of more than one study. We found ample scope for future cost-effectiveness studies, particularly analyses of entire recovery pathways and comparison of incremental changes within pathways. A key limitation is that standard practices have changed over the period covered by the included studies. PROSPERO REGISTRATION NUMBER:CRD42017059473.

Project description:IntroductionHip and knee replacement represents a significant burden to the UK healthcare system. 'Enhanced recovery' pathways have been introduced in the National Health Service (NHS) for patients undergoing hip and knee replacement, with the aim of improving outcomes and timely recovery after surgery. To support policymaking, there is a need to evaluate the cost-effectiveness of enhanced recovery pathways across jurisdictions. Our aim is to systematically summarise the published cost-effectiveness evidence on enhanced recovery in hip and knee replacement, both as a whole and for each of the various components of enhanced recovery pathways.Methods and analysisA systematic review will be conducted using MEDLINE, EMBASE, Econlit and the National Health Service Economic Evaluations Database. Separate search strategies were developed for each database including terms relating to hip and knee replacement/arthroplasty, economic evaluations, decision modelling and quality of life measures.We will extract peer-reviewed studies published between 2000 and 2017 reporting economic evaluations of preoperative, perioperative or postoperative enhanced recovery interventions within hip or knee replacement. Economic evaluations alongside cohort studies or based on decision models will be included. Only studies with patients undergoing elective replacement surgery of the hip or knee will be included. Data will be extracted using a predefined pro forma following best practice guidelines for economic evaluation, decision modelling and model validation.Our primary outcome will be the cost-effectiveness of enhanced recovery (entire pathway and individual components) in terms of incremental cost per quality-adjusted life year. A narrative synthesis of all studies will be presented, focussing on cost-effectiveness results, study design, quality and validation status.Ethics and disseminationThis systematic review is exempted from ethics approval because the work is carried out on published documents. The results of the review will be disseminated in a peer-reviewed academic journal and at conferences.Prospero registration numberCRD42017059473.

Dataset Information

Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial.

Publications

Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial.

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