Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol (POWER3)

Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol POWER3

Methods National audit of a 90-day prospective observational cohort in which pre-defined postoperative complications were analyzed at 30 days of follow-up in adult patients undergoing elective bariatric surgery with or without an intensified recovery program (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%)

Research Places Spanish Hospitals where this surgical intervention is carried out.

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 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 11%, the sample size calculation yields 460 patients, although the final sample size it may be smaller depending on the proportion of complications detected.

Inclusion criteria Patients older than 18 years who are going to be electively operated on for bariatric surgery regardless of their adherence to an ERAS intensified recovery program and the compliance level of the 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 normally distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the factors associated with postoperative complications, hospital stay and death in the hospital. Univariate analyzes and hierarchical multivariate logistic regression models will be constructed to identify factors associated independently with these results and to adjust for differences in confounding factors. 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: Postoperative Complications; Bariatric Surgery Candidate; Perioperative Care

Detailed Description

The results of this study will allow to identify, on the one hand, the type of patients presenting postoperative complications and, on the other hand, to identify those items of the ERAS protocols that are independently associated with a reduction in postoperative complications and hospital stay, which will allow to focus the perioperative efforts in those items that actually improve the postoperative outcomes.

Aim 1 will establish the number of patients developing predefined postoperative complications within 30 days of surgery in adult patients undergoing elective bariatric surgery with any compliance of an ERAS protocol (including patients with 0 compliance). This will allow us to determine the actual impact of these protocols.

Aim 2 will allow us to know the type of predefined complication presented by the patients included in the ERAS protocols and in patients undergoing bariatric surgery; This will allow, on the one hand, to have a starting point for future clinical trials, and, on the other hand, to focus efforts to avoid these complications.

Aim 3 will allow us to identify those perioperative items of ERAS protocols that are actually associated with a decrease in postoperative complications.

The proposed study will establish a real view of the number of patients presenting postoperative complications that will overcome the limitations of available retrospective studies and provide greater insight into the items of the protocols that are associated with decreased complications; on the other hand, the investigator's hypothesis is that the number of patients who develop predefined postoperative complications within 30 days of surgery decreases as there is greater compliance with the predefined ERAS protocol items

• Study Type: Observational
• Enrollment (Anticipated): 460

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Universitario Vall d´Hebron
  • Barcelona, Spain
    • Hospital Clínic Universitat de Barcelona
  • Barcelona, Spain
    • Hospital Universitario Sant Pau
  • Burgos, Spain
    • Hospital Universitario de Burgos
  • Ciudad Real, Spain
    • Hospital General Universitario de Ciudad Real
  • Guadalajara, Spain
    • Hospital Universitario de Guadalajara
  • Las Palmas, Spain
    • Hospital Universitario de Gran Canaria Doctor Negrin
  • Las Palmas de Gran Canaria, Spain
    • Hospital Universitario Insular de Gran Canaria
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain
    • Hospital De La Princesa
  • Madrid, Spain
    • Hospital Universitario Infanta Leonor
  • Menorca, Spain
    • Hospital General Mateu Orfila
  • Murcia, Spain
    • Hospital General Universitario José María Morales Messeguer
  • Pontevedra, Spain
    • Complejo Hospitalario y Universitario de Pontevedra
  • Santander, Spain
    • Hospital Universitario Marques de Valdecilla
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain
    • Hospital Universitario Virgen de Valme
  • Toledo, Spain
    • Complejo Hospitalario de Toledo
  • Valencia, Spain
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain
    • Hospital Universitario La Fe
  • Valencia, Spain
    • Hospital General Universitario de Valencia
  • Valladolid, Spain
    • Hospital Universitario Rio Hortega
  • Valladolid, Spain
    • Hospital Clínico de Valladolid
  • Vitoria, Spain
    • Hospital Universitario de Álava
  • Zaragoza, Spain
    • Hospital Clinico Universitario Lozano Blesa
  • Zaragoza, Spain
    • Hospital Universitario Miguel Server
  • Alicante
    • Alcoy, Alicante, Spain
      • Hospital Virgen de los Lirios de Alcoy
    • Elche, Alicante, Spain
      • Hospital General Universitario de Elche
  • Asturias
    • Oviedo, Asturias, Spain
      • Hospital Universitario Central de Asturias
  • Badajoz
    • Mérida, Badajoz, Spain
      • Hospital de Mérida
  • Barcelona
    • Sabadell, Barcelona, Spain
      • Hospital Universitario Parc Taulí
    • Sant Joan d'Espi, Barcelona, Spain
      • Hospital de Sant Joan Despi Moises Broggi
    • Vic, Barcelona, Spain
      • Hospital Universitario de Vic
  • Bizkaia
    • Baracaldo, Bizkaia, Spain
      • Hospital Universitario de Cruces
  • Castellón
    • Castellon de la Plana, Castellón, Spain
      • Hospital General Universitario de Castellon
  • Coruña
    • A Coruna, Coruña, Spain
      • Complejo Hospitalario Universitario de A Coruña
  • Cádiz
    • Cadiz, Cádiz, Spain
      • Hospital Universitario Puerta Del Mar
    • Jerez de La Frontera, Cádiz, Spain
      • Hospital Universitario Jerez de la Frontera
  • Madrid
    • Alcalá de Henares, Madrid, Spain
      • Hospital Universitario Príncipe de Asturias
    • Alcorcón, Madrid, Spain
      • Hospital Universitario Fundacion Alcorcon
    • Fuenlabrada, Madrid, Spain
      • Hospital Universitario de Fuenlabrada
    • Getafe, Madrid, Spain
      • Hospital Universitario Getafe
    • Majadahonda, Madrid, Spain
      • Hospital Universitario Puerta de Hierro
    • Mostoles, Madrid, Spain
      • Hospital Rey Juan Carlos
    • Mostoles, Madrid, Spain
      • Hospital Universitario de Móstoles
    • Pozuelo de Alarcon, Madrid, Spain
      • Hospital Universitario Quiron Madrid
    • Torrejon de Ardoz, Madrid, Spain
      • Hospital Universitario De Torrejon
  • Málaga
    • Malaga, Málaga, Spain
      • Hospital Universitario Virgen del Victoria de Málaga
    • Marbella, Málaga, Spain
      • Hospital Costa Del Sol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (aged ≥18 years) undergoing elective bariatric surgery

Description

Inclusion Criteria:

• All adult patients (aged ≥18 years) undergoing elective bariatric surgery and by any approach (Includes surgery with laparoscopic, assisted laparoscopic approach or open approach) in a participating hospital during the 30-day cohort period with a planned overnight stay.

Exclusion Criteria:

• Patients undergoing emergency surgery

  • Endoscopic procedures
  • Patients under 18 years of age
  • Patients with previous bariatric surgery who undergo revision surgery
  • Patients who refuse to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elective Bariatric Surgery; Patients older than 18 undergoing elective bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predefined mild-moderate-severe postoperative complications	Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine were published by the European Perioperative Clinical Outcome (EPCO) definitions. Infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay	The median hospital length of stay (LOS) following the start of surgery, overall, by survival status and by complication status will be reported. Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital.	30 days after surgery
In-hospital all-cause mortality	The percentage of deaths within 30 days of surgery will be reported for each surgical category	30 days after surgery
ERAS Compliance	Overall compliance will be calculated as the average of all pre- and intraoperative ERAS adapted elements, as specified in the ERAS society bariatric guidelines ERAS patients' guideline compliance will be categorised into quartiles	30 days after surgery

Collaborators and Investigators

• Sponsor: Grupo Español de Rehabilitación Multimodal
• Collaborators: REDGERM; Sociedad Española de Cirugía de la Obesidad
• Investigators: Study Chair: Javier M Ripollés-Melchor, Infanta Leonor University Hospital, Madrid, Spain; Study Chair: Raquel M Sanchez Santos, Complejo Hospitalario Universitario de Vigo; Study Director: José M Ramírez, Lozano Blesa University Hospital, Zaragoza, Spain; Study Director: Jaime Ruiz Tovar, Hospital Universitario Rey Juan Carlos Móstoles, Spain; Study Director: César Aldecoa, Hospital Universitario Río Hortega, Valladolid, Spain; Study Director: Carlos Ferrando-Ortolá, Hospital Clinic of Barcelona; Study Director: Ester Martín García-Almenta, Hospital Universitario Clínico San Carlos, Madrid; Study Director: Ane Abad-Motos, Infanta Leonor University Hospital, Madrid, Spain; Study Director: Alfredo Abad-Gurumeta, Infanta Leonor University Hospital, Madrid, Spain; Study Director: Alejandro Suárez de la Rica, Hospital Universitario La Paz

Publications and helpful links

General Publications

• Ripolles-Melchor J, Sanchez-Santos R, Abad-Motos A, Gimeno-Moro AM, Diez-Remesal Y, Jove-Albores P, Arago-Chofre P, Ortiz-Sebastian S, Sanchez-Martin R, Ramirez-Rodriguez JM, Trullenque-Juan R, Valenti-Azcarate V, Ramiro-Ruiz A, Correa-Chacon OC, Batalla A, Gimeno-Grauwinkel C, Sanahuja-Blasco JM, Gonzalez-Valverde FM, Galan-Menendez P, Diez-Zapirain MJ, Vilallonga R, Zorrilla-Vaca A, Pascual-Bellosta AM, Martinez-Ubieto J, Carrascosa-Miron T, Ruiz-Escobar A, Martin-Garcia-Almenta E, Suarez-de-la-Rica A, Bausili M, Palacios-Cordoba A, Olvera-Garcia MM, Meza-Vega JA, Sanchez-Pernaute A, Abad-Gurumeta A, Ferrando-Ortola C, Martin-Vaquerizo B, Torres-Alfonso JR, Aguado-Sanchez S, Sanchez-Cabezudo-Noguera F, Garcia-Erce JA, Aldecoa C; POWER 3 Study Investigators Group. Higher Adherence to ERAS Society(R) Recommendations is Associated with Shorter Hospital Stay Without an Increase in Postoperative Complications or Readmissions in Bariatric Surgery: the Association Between Use of Enhanced Recovery After Surgery Protocols and Postoperative Complications after Bariatric Surgery (POWER 3) Multicenter Observational Study. Obes Surg. 2022 Apr;32(4):1289-1299. doi: 10.1007/s11695-022-05949-6. Epub 2022 Feb 10.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 22, 2019
• Primary Completion (Anticipated): February 22, 2020
• Study Completion (Anticipated): March 22, 2020

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

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

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: REDGERM04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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