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

NCT03570944 | Unknown DMC

• 1 other identifier: RedGerm02
• Study Type: observational
• Target: 3,012
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Keywords

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mortality

  30 day

• Hospital Stay

  30 day

Other Outcomes (1)

• ERAS overall compliance

  30 day

Study Arms (1)

Patients undergoing elective HRS or KRS

Adult patients undergoing elective HRS or KNS

Procedure: HRS, KRS

Interventions

HRS, KRS PROCEDURE

Elective HRS or KNR in adult patients, with any ERAS compliance

Patients undergoing elective HRS or KRS

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients

You may qualify if:

• Total elective knee replacement surgery(primary)
• Total elective hip replacement surgery (primary)

You may not qualify if:

• Patients undergoing emergency surgery.
• Partial prostheses
• Replacement of prosthesis
• Patients who decline to participate

Sponsors & Collaborators

• Grupo Español de Rehabilitación Multimodal: lead

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 25058504 RESULT

• 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.

  PMID: 22810157 RESULT

• 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.

  PMID: 27043725 RESULT

• 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.

  PMID: 15744696 RESULT

• 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.

  PMID: 31183463 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Lysine-tRNA Ligase

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acyl-tRNA Synthetases; Carbon-Oxygen Ligases; Ligases; Enzymes; Enzymes and Coenzymes

Study Officials

• Ane Abad Motos, MD

  Infanta Leonor University Hospital

  STUDY DIRECTOR

Central Study Contacts

Javier Ripollés-Melchor, MD

CONTACT

34620965143; ripo542@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2018
• First Posted: June 27, 2018
• Study Start: October 22, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 28, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years
• Access Criteria: Mail to: power2@grupogerm.es

Locations

ES (1)