Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer
POWER4
1 other identifier
observational
861
1 country
66
Brief Summary
Methods National audit of a 90-day prospective observational cohort in which postoperative complications will be analyzed at 30 days of follow-up in adult patients undergoing scheduled surgery for gastric resection for cancer with or without an intensified recovery program (ERAS : Enhanced Recovery after Surgery) with any level of protocol compliance (from 0-100%) Research Locations Spanish Hospitals at the state level where these surgical interventions are performed on a regular basis. 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 28%, the sample size calculation yields 861 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 undergo surgery for gastric resection surgery due to cancer regardless of their affiliation to an ERAS intensified recovery program and the compliance level of the protocol (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Shorter than P25 for all trials
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2020
CompletedMarch 8, 2019
March 1, 2019
4 months
March 4, 2019
March 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with 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 EPCO definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome mesures. infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.
30 days after surgery
Number of patients with predefined mild-moderate-severe postoperative complications (gastric cancer surgery specific)
Each complication will be graded as mild, moderate or severe.
30 days after surgery
Secondary Outcomes (3)
In-hospital all-cause mortality
30 days after surgery
Compliance with ERAS items
30 days after surgery
Duration of hospital stay
30 days after surgery
Study Arms (1)
Gastric Surgery
Adult patients undergoing elective gastric surgery for cancer
Eligibility Criteria
Patients over 18 years of age undergoing gastric resection surgery due to cancer
You may qualify if:
- All patients over 18 years of age undergoing gastric resection surgery due to cancer within or not of an intensified recovery program (ERAS) with any level of compliance with the protocol (from 0-100%).
You may not qualify if:
- Patients undergoing emergency surgery
- Endoscopic procedures
- Non-oncological gastric surgery
- Patients who refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Hospital Virgen de los Lirios de Alcoy
Alcoy, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Don Benito-Villanueva de la Serena
Don Benito-Villanueva de La Serena, Badajoz, Spain
Hospital de Mérida
Mérida, Badajoz, Spain
Hospital de Igualada
Igualada, Barcelona, Spain
Hospital Universitario Parc Tauli
Sabadell, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan d'Espi, Barcelona, Spain
Fundación Hospital del Espíritu Santo
Santa Coloma de Gramanet, Barcelona, Spain
Hospital Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Vic
Vic, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, Spain
Hospital Comarcal de Vinaroz
Vinaròs, Castellón, Spain
Complejo Hospitalario Universitario de A Coruña
A Coruña, Coruña, Spain
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, Spain
Complejo Asistencial Universitario de León
León, León, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Getafe
Getafe, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain
Hospital Comarcal de Inca
Inca, Mallorca, Spain
Hospital de Manacor
Manacor, Mallorca, Spain
Hospital Rafael Méndez
Lorca, Murcia, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Clínic Universitat de Barcelona
Barcelona, Spain
Hospital Universitario Sant Pau
Barcelona, Spain
Hospital Universitario Vall d´Hebrón
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital de La Princesa
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital General Universitario José María Morales Messeguer
Murcia, Spain
Hospital Reina Sofía
Murcia, Spain
Complejo Hospitalario y Universitario de Pontevedra
Pontevedra, Spain
Complejo Hospitalario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Complejo Asistencial de Segovia
Segovia, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Complejo Hospitalario de Toledo
Toledo, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Clínico de Valladolid
Valladolid, Spain
Hospital Universitario Río Hortega
Valladolid, Spain
Hospital Universitario de Álava
Vitoria-Gasteiz, Spain
Complejo Asistencial de Zamora
Zamora, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Related Publications (2)
Ripolles-Melchor J, Abad-Motos A, Bruna-Esteban M, Garcia-Nebreda M, Otero-Martinez I, Abdel-Lah Fernandez O, Tormos-Perez MP, Paseiro-Crespo G, Garcia-Alvarez R, A Mayo-Ossorio M, Zugasti-Echarte O, Nespereira-Garcia P, Gil-Gomez L, Logrono-Ejea M, Risco R, Parreno-Manchado FC, Gil-Trujillo S, Benito C, Jerico C, De-Miguel-Cabrera MI, Ugarte-Sierra B, Barragan-Serrano C, Garcia-Erce JA, Munoz-Hernandez H, Rio-Fernandez SD, Herrero-Bogajo ML, Espinosa-Moreno AM, Concepcion-Martin V, Zorrilla-Vaca A, Vaquero-Perez L, Mojarro I, Llacer-Perez M, Gomez-Viana L, Fernandez-Martin MT, Abad-Gurumeta A, Ferrando-Ortola C, Ramirez-Rodriguez JM, Aldecoa C; POWER Study Investigators Group. Association between use of enhanced recovery after surgery protocols and postoperative complications after gastric surgery for cancer (POWER 4): a nationwide, prospective multicentre study. Cir Esp (Engl Ed). 2023 Oct;101(10):665-677. doi: 10.1016/j.cireng.2023.04.011. Epub 2023 Apr 23.
PMID: 37094777DERIVEDAbad-Motos A, Ripolles-Melchor J, Bruna-Esteban M, Ferrando-Ortola C, Paseiro-Crespo G, Abad-Gurumeta A, Garcia-Erce JA, Jerico C, Ramirez JM, Aldecoa C. Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Mar;67(3):130-138. doi: 10.1016/j.redar.2019.10.004. Epub 2019 Nov 22. English, Spanish.
PMID: 31767197DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Javier Ripollés-Melchor
Infanta Leonor University Hospital, Madrid, Spain
- STUDY CHAIR
Marcos Bruna Esteban
Hospital General Universitario de Valencia, Spain
- STUDY CHAIR
José M Ramírez Rodríguez
Lozano Blesa University Hospital, Zaragoza, Spain
- STUDY CHAIR
César Aldecoa
Hospital Universitario Río Hortega, Valladolid Spain
- STUDY CHAIR
Ane Abad Motos
Infanta Leonor University Hospital, Madrid, Spain
- STUDY DIRECTOR
Peter Vorwald
Hospital Universitario Fundación Jiménez Díaz. Madrid, Spain
- STUDY DIRECTOR
Gloria Crespo
Infanta Leonor University Hospital, Madrid, Spain
- STUDY DIRECTOR
Carlos Ferrando Ortolá
Hospital Clinic of Barcelona
- STUDY DIRECTOR
Joaquín Rodríguez Santiago
Hospital Mutua Teresa, Spain
- STUDY DIRECTOR
José A García Erce
Servicio Navarro de Salud - Osasunbidea. Pamplona, Spain
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 7, 2019
Study Start
October 22, 2019
Primary Completion
February 22, 2020
Study Completion
March 22, 2020
Last Updated
March 8, 2019
Record last verified: 2019-03