Dataset Information

Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty. POWER.2 Study: Study Protocol for a Prospective, Multicentre, Observational Cohort Study.

ABSTRACT: Objective:The number of indications for total hip replacement (THR) and total knee replacement (TKR) surgery is increasing. Enhanced recovery after surgery (ERAS) represents the next step in the evolution of standardised care. The primary aim of this study is to measure the in-hospital 30-day medical and surgical postoperative complications rate. The study's secondary aims are to determine the length of stay, 30-day mortality rate, 30-day reoperation and readmission rates, the ERAS overall compliance and predefined ERAS individual items compliance. Methods:This multicentre, prospective, observational study will include adult patients (aged >18 years) undergoing elective THR and TKR surgery. Consecutive patients undergoing surgery within the 2-month data collection period will be included. Centres that offer the THR and/or TKR surgery will be eligible to participate. The data collection will be done through an online data collection form via a secure, password-protected platform at each centre with predefined data fields. Results:Ethical approval for this study has been obtained from the Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (C.P.-C.I. PI18/135; on 23 May 2018). It was prospectively registered on 27 June 2018, at www.clinicaltrials.gov with identification no. NCT03570944. Conclusion:The study will be disseminated through the SPARN-RedGERM, SEDAR, GERM and through social media. Peer-reviewed publications will be published under corporate authorship, including POWER.2 Study Group and SPARN-RedGERM.

SUBMITTER: Ripolles-Melchor J

PROVIDER: S-EPMC6537954 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty. POWER.2 Study: Study Protocol for a Prospective, Multicentre, Observational Cohort Study.

Ripollés-Melchor Javier J Abad-Motos Ane A Logroño-Egea Margarita M Aldecoa César C García-Erce José Antonio JA Jiménez-López Ignacio I Cassinello-Ogea Concepción C Marín-Peña Oliver O Ferrando-Ortolá Carlos C de la Rica Alejandro Suárez AS Gómez-Ríos Manuel A MA Sánchez-Martín Rubén R Abad-Gurumeta Alfredo A Casans-Francés Rubén R Mugarra-Llopis Ana A Varela-Durán Marina M Longás-Valién Javier J Ramiro-Ruiz Álvaro Á Cuellar-Martínez Ana B AB Ramírez-Rodríguez José M JM Calvo-Vecino José M JM

Turkish journal of anaesthesiology and reanimation 20190124 3

<h4>Objective</h4>The number of indications for total hip replacement (THR) and total knee replacement (TKR) surgery is increasing. Enhanced recovery after surgery (ERAS) represents the next step in the evolution of standardised care. The primary aim of this study is to measure the in-hospital 30-day medical and surgical postoperative complications rate. The study's secondary aims are to determine the length of stay, 30-day mortality rate, 30-day reoperation and readmission rates, the ERAS overa ...[more]

PMID: 31183463

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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:BackgroundThe number of hip, knee and shoulder arthroplasties continues to rise worldwide. The Organization for Economic Cooperation and Development has launched an initiative (called PaRIS Initiative) for the systematic collection of Patient Reported Outcome Measures (PROMs) in patients undergoing elective hip and knee arthroplasty. The Rizzoli Orthopedic Institute (IOR) was selected as a pilot center for the launch of the Initiative in Italy given that IOR hosts the Registry of Orthopedic Prosthetic Implants (RIPO), a region-wide registry which collects joint implant data from all the hospitals in the Emilia-Romagna Region. In this specific geographic area information related to PROMs after joint replacement is unknown. This paper describes the protocol of a study (PaRIS-IOR) that aims to implement the collection of a set of PROMs within an existing implant registry in Italy. The study will also investigate the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.MethodsThe PaRIS-IOR study is a prospective, single site, cohort study that consists of the administration of PROMs questionnaires to patients on the list for elective arthroplasty. The questionnaires will be administered to the study population within 30 days before surgery, and then at 6 and 12 months following surgery. The study population will consist of consecutive adult patients undergoing either hip, knee or shoulder arthroplasty. The collected data will be linked with those routinely collected by the RIPO in order to assess the temporal trend of PROMs in relation to the type of prosthesis and the type of surgical intervention.DiscussionThe PaRIS-IOR study could have important implications in targeting the factors influencing functional outcomes and quality of life reported by patients after hip, knee and shoulder arthroplasty, and will also represent the first systematic collection of PROMs related to arthroplasty in Italy.Trial registrationProtocol version (1.0) and trial registration data are available on the platform www.clinicaltrial.gov with the identifier NCT03790267 , first posted on December 31, 2018.

Dataset Information

Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty. POWER.2 Study: Study Protocol for a Prospective, Multicentre, Observational Cohort Study.

Publications

Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty. POWER.2 Study: Study Protocol for a Prospective, Multicentre, Observational Cohort Study.

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