- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03570944
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2) (POWER2)
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol National Audit of Complications Following Elective Total Hip or Knee Replacement Within or Without an Enhanced Recovery After Surgery Protocol (POWER2)
Methods National audit of a 60-day prospective observational cohort in the that the pre-defined postoperative complications at 30 days of follow-up in adult patients electively undergoing hip replacement surgery (HRS) or knee replacement surgery (KRS) with or without a program of Enhanced Recovery (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%)
Research Places Spanish Hospitals where these surgical interventions are performed usually
Objectives To determine the incidence of Postoperative Complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the Hospital Stay and on postoperative complications including 30-day mortality
Sample Size For an alpha error of 5% (95% confidence and an accuracy of 3% and estimating a number of patients with complications of 50%, the calculation of sample size yields 3012 patients, although the final sample size may be smaller depending on the proportion of complications detected.
Inclusion criteria Patients over 18 undergoing elective HRS or KRS PTC regardless of its affiliation to a ERAS program and the level of compliance with protocol (from 0-100%)
Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not distributed normally. The comparisons of continuous variables are performed by one-way ANOVA or the Mann-Whitney test, depending on proceed A univariate analysis will be carried out to test the factors associated with postoperative complications, hospital stay and death in Hospital. Univariate analyzes and logistic regression models will be constructed Hierarchical multivariate to identify the factors associated in a independent with these results and to adjust the differences in the factors of confusion. The factors will be introduced in the models based on their relationship with the univariate result (p <0.05), the biological plausibility and the low rate of missing data.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Javier Ripollés-Melchor, MD
- Telefonnummer: 34620965143
- E-post: ripo542@gmail.com
Studiesteder
-
-
-
Madrid, Spania
- Rekruttering
- Hospital Universitario Infanta Leonor
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
All patients over 18 who undergoing HRS or KRS with or without an ERAS intensified recovery program with any level of protocol compliance (0-100%) Surgeries planned by inclusion criteria
- Total elective knee replacement surgery(primary)
- Total elective hip replacement surgery (primary)
Exclusion Criteria:
Patients undergoing emergency surgery.
- Partial prostheses
- Replacement of prosthesis
- Patients who decline to participate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Patients undergoing elective HRS or KRS
Adult patients undergoing elective HRS or KNS
|
Elective HRS or KNR in adult patients, with any ERAS compliance
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
30 day postoperative complications
Tidsramme: 30 days
|
Complications are defined according to Standards for definitions and use of outcomes for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions (1), the standardized list and definitions of the Knee Society (2) and Standardized List , Definitions, and the Stratification Developed by The Hip Society (3)
|
30 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mortality
Tidsramme: 30 day
|
30 day mortality
|
30 day
|
Hospital Stay
Tidsramme: 30 day
|
Primary hospital stay after surgery
|
30 day
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
ERAS overall compliance
Tidsramme: 30 day
|
ERAS compliance according to (4)
|
30 day
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Ane Abad Motos, MD, Infanta Leonor University Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, Lonner JH. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013 Jan;471(1):215-20. doi: 10.1007/s11999-012-2489-y.
- Healy WL, Iorio R, Pellegrini VD, Della Valle CJ, Berend KR. Reply to the Letter to the Editor: Complications of Total Hip Arthroplasty: Standardized List, Definitions, and Stratification Developed by the Hip Society. Clin Orthop Relat Res. 2016 Jun;474(6):1528-9. doi: 10.1007/s11999-016-4804-5. Epub 2016 Apr 4. No abstract available.
- Berend KR, Lombardi AV Jr, Mallory TH. Rapid recovery protocol for peri-operative care of total hip and total knee arthroplasty patients. Surg Technol Int. 2004;13:239-47.
- Ripolles-Melchor J, Abad-Motos A, Logrono-Egea M, Aldecoa C, Garcia-Erce JA, Jimenez-Lopez I, Cassinello-Ogea C, Marin-Pena O, Ferrando-Ortola C, de la Rica AS, Gomez-Rios MA, Sanchez-Martin R, Abad-Gurumeta A, Casans-Frances R, Mugarra-Llopis A, Varela-Duran M, Longas-Valien J, Ramiro-Ruiz A, Cuellar-Martinez AB, Ramirez-Rodriguez JM, Calvo-Vecino JM. 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. Turk J Anaesthesiol Reanim. 2019 Jun;47(3):179-186. doi: 10.5152/TJAR.2019.87523. Epub 2019 Jan 24.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- RedGerm02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Artroplastikk, erstatning, kne
-
Smith & Nephew, Inc.Nor Consult, LLCFullførtJourney II XR Total Knee SystemForente stater
-
Smith & Nephew, Inc.FullførtJourney II BCS Total Knee SystemForente stater, Belgia, New Zealand
-
Smith & Nephew, Inc.Nor ConsultFullførtJourney II CR Total Knee SystemForente stater
-
Central DuPage HospitalAvsluttetTotalt kneskifte | Erstatning, Total Knee | Artroplastikk, kneproteseForente stater
-
University of VirginiaFullførtArtrose | Tibial Femoral Knee ArtroseForente stater
-
Bispebjerg HospitalFullførtPatellar Tendinopathy / Jumpers KneeDanmark
-
Istituto Ortopedico RizzoliRekrutteringOsteochondritis Dissecans KneeItalia
-
3D Metal Printing LtdUniversity of BathUkjentUnicompartmental Medial Knee ArtroseItalia
-
Maxx Orthopedics IncRekrutteringBein tap | Periprotetiske brudd | Infeksjon | Aseptisk løsning | MCL - Medial Collateral Ligament Rupture of the KneeForente stater
-
Boston Children's HospitalTexas Scottish Rite Hospital for ChildrenRekrutteringPsykologisk stress | Osteochondritis Dissecans KneeForente stater
Kliniske studier på HRS, KRS
-
Restor3DFullført
-
Shandong Suncadia Medicine Co., Ltd.Har ikke rekruttert ennåAvansert ondartet svulst
-
Shandong Suncadia Medicine Co., Ltd.Har ikke rekruttert ennå
-
Jiangsu HengRui Medicine Co., Ltd.RekrutteringAvanserte solide svulsterKina
-
Jiangsu HengRui Medicine Co., Ltd.RekrutteringAvansert prostatakreftKina
-
Jiangsu HengRui Medicine Co., Ltd.RekrutteringAvanserte KRAS G12D mutante solide svulsterKina
-
Restor3DAvsluttetArtrose, kneForente stater
-
Jiangsu HengRui Medicine Co., Ltd.Har ikke rekruttert ennå
-
Jiangsu HengRui Medicine Co., Ltd.Har ikke rekruttert ennåAvansert ondartet kreft
-
Shandong Suncadia Medicine Co., Ltd.RekrutteringAvansert ondartet svulstKina