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.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Procedure: HRS, KRS

• Study Type: Observational
• Enrollment (Anticipated): 3012

Contacts and Locations

• Study Contact: Name: Javier Ripollés-Melchor, MD; Phone Number: 34620965143; Email: ripo542@gmail.com

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Infanta Leonor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing elective HRS or KRS; Adult patients undergoing elective HRS or KNS	Procedure: HRS, KRS; Elective HRS or KNR in adult patients, with any ERAS compliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day postoperative complications	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	30 day mortality	30 day
Hospital Stay	Primary hospital stay after surgery	30 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ERAS overall compliance	ERAS compliance according to (4)	30 day

Collaborators and Investigators

• Sponsor: Grupo Español de Rehabilitación Multimodal
• Investigators: Study Director: Ane Abad Motos, MD, Infanta Leonor University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Anticipated): March 28, 2019

Study Registration Dates

• First Submitted: June 17, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative Complications
• Other Study ID Numbers: RedGerm02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Under request
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Mail to: power2@grupogerm.es
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No