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Brief Title: Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer
Official Title: Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER .4)
Study ID: NCT03865810
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.
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 scheduled surgery for gastric resection for cancer 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 colorectal 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Virgen de los Lirios de Alcoy, Alcoy, Alicante, Spain
Hospital General Universitario de Elche, Elche, Alicante, Spain
Hospital Universitario Central de Asturias, Oviedo, Asturias, 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, Baracaldo, Bizkaia, Spain
Hospital General Universitario de Castellón, Castellon de la Plana, Castellón, Spain
Hospital Comarcal de Vinaroz, Vinaroz, Castellón, Spain
Complejo Hospitalario Universitario de A Coruña, A Coruna, Coruña, Spain
Hospital Universitario Puerta del Mar, Cadiz, Cádiz, Spain
Complejo Asistencial Universitario de León, Leon, 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, Mostoles, Madrid, Spain
Hospital Universitario de Móstoles, Mostoles, Madrid, Spain
Hospital Universitario Quirón Madrid, Pozuelo de Alarcon, Madrid, Spain
Hospital Universitario de Torrejón, Torrejon 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, Navarra, 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 Insular de Gran Canaria, Las Palmas de Gran Canaria, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, , 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, Sevilla, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , 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, , Spain
Complejo Asistencial de Zamora, Zamora, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Name: Javier Ripollés-Melchor
Affiliation: Infanta Leonor University Hospital, Madrid, Spain
Role: STUDY_CHAIR
Name: Marcos Bruna Esteban
Affiliation: Hospital General Universitario de Valencia, Spain
Role: STUDY_CHAIR
Name: José M Ramírez Rodríguez
Affiliation: Lozano Blesa University Hospital, Zaragoza, Spain
Role: STUDY_CHAIR
Name: César Aldecoa
Affiliation: Hospital Universitario Río Hortega, Valladolid Spain
Role: STUDY_CHAIR
Name: Ane Abad Motos
Affiliation: Infanta Leonor University Hospital, Madrid, Spain
Role: STUDY_CHAIR
Name: Peter Vorwald
Affiliation: Hospital Universitario Fundación Jiménez Díaz. Madrid, Spain
Role: STUDY_DIRECTOR
Name: Gloria Crespo
Affiliation: Infanta Leonor University Hospital, Madrid, Spain
Role: STUDY_DIRECTOR
Name: Carlos Ferrando Ortolá
Affiliation: Hospital Clinic of Barcelona
Role: STUDY_DIRECTOR
Name: Joaquín Rodríguez Santiago
Affiliation: Hospital Mutua Teresa, Spain
Role: STUDY_DIRECTOR
Name: José A García Erce
Affiliation: Servicio Navarro de Salud - Osasunbidea. Pamplona, Spain
Role: STUDY_DIRECTOR