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

• ClinicalTrials.gov Identifier: NCT03570944
• Recruitment Status: Unknown
• First Posted: June 27, 2018
• Last Update Posted: March 6, 2019
• Sponsor: Grupo Español de Rehabilitación Multimodal
• Information provided by (Responsible Party): Grupo Español de Rehabilitación Multimodal

Study Description

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.

Condition or disease	Intervention/treatment
Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee	Procedure: HRS, KRS

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 3012 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 30 Days
• Official Title: 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)
• Actual Study Start Date: October 22, 2018
• Actual Primary Completion Date: February 28, 2019
• Estimated Study Completion Date: March 28, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 30 day postoperative complications [ Time Frame: 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 :

1. Mortality [ Time Frame: 30 day ]
   30 day mortality
2. Hospital Stay [ Time Frame: 30 day ]
   Primary hospital stay after surgery

Other Outcome Measures:

1. ERAS overall compliance [ Time Frame: 30 day ]
   ERAS compliance according to (4)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult patients

Criteria

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

Contacts and Locations

Contacts

Contact: Javier Ripollés-Melchor, MD; 34620965143; ripo542@gmail.com

Locations

Spain

Hospital Universitario Infanta Leonor; Recruiting

Madrid, Spain

Contact: Javier Ripollés Melchor, MD 649337762 ripo542@gmail.com

Sub-Investigator: Eugenio Martínez Hurtado, MD

Sub-Investigator: Alfredo Abad Gurumeta, PhD

Sub-Investigator: Elena Sáez Ruiz, MD

Sub-Investigator: Ane Abad Motos, MD

Sub-Investigator: Norma Aracil Escoda, MD

Sub-Investigator: Beatriz Nozal Mateo, MD

Sub-Investigator: Rut Salvachua, MD

Sub-Investigator: Oliver Marín Pena

Sponsors and Collaborators

Grupo Español de Rehabilitación Multimodal

Investigators

• Study Director: Ane Abad Motos, MD; Infanta Leonor University Hospital

More Information

Additional Information:

Publications of Results:

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.

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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ripollés-Melchor J, Abad-Motos A, Logroño-Egea M, Aldecoa C, García-Erce JA, Jiménez-López I, Cassinello-Ogea C, Marín-Peña O, Ferrando-Ortolá C, de la Rica AS, Gómez-Ríos MA, Sánchez-Martín R, Abad-Gurumeta A, Casans-Francés R, Mugarra-Llopis A, Varela-Durán M, Longás-Valién J, Ramiro-Ruiz Á, Cuellar-Martínez AB, Ramírez-Rodríguez 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.

• Responsible Party: Grupo Español de Rehabilitación Multimodal
• ClinicalTrials.gov Identifier: NCT03570944
• Other Study ID Numbers: RedGerm02
• First Posted: June 27, 2018
• Last Update Posted: March 6, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Under request
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: 2 years
• Access Criteria: Mail to: power2@grupogerm.es
• URL: http://www

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Grupo Español de Rehabilitación Multimodal:

Postoperative Complications