Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Procedure: HRS, KRS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing elective HRS or KRS<br>Adult patients undergoing elective HRS or KNS | Procedure: HRS, KRS<br>* Elective HRS or KNR in adult patients, with any ERAS compliance<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Complications