Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)
- Conditions
- Arthroplasty, Replacement, KneeArthroplasty, Replacement, Hip
- Interventions
- Procedure: HRS, KRS
- Registration Number
- NCT03570944
- Lead Sponsor
- Grupo Espa帽ol de Rehabilitaci贸n Multimodal
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3012
-
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)
-
Patients undergoing emergency surgery.
- Partial prostheses
- Replacement of prosthesis
- Patients who decline to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing elective HRS or KRS HRS, KRS Adult patients undergoing elective HRS or KNS
- Primary Outcome Measures
Name Time Method 30 day postoperative complications 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)
- Secondary Outcome Measures
Name Time Method Mortality 30 day 30 day mortality
Hospital Stay 30 day Primary hospital stay after surgery
Trial Locations
- Locations (1)
Hospital Universitario Infanta Leonor
馃嚜馃嚫Madrid, Spain