Clinical trial NCT03865810: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Care
Postoperative Complications
Gastric Cancer
Lead sponsor: Grupo Español de Rehabilitación Multimodal
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 861
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age undergoing gastric resection surgery due to cancer

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

Eligibility criteria: Inclusion Criteria:

* 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%).

Exclusion Criteria:

* Patients undergoing emergency surgery

  * Endoscopic procedures
  * Non-oncological gastric surgery
  * Patients who refuse to participate

Primary outcomes:
measure: Number of patients with predefined mild-moderate-severe postoperative complications
timeFrame: 30 days after surgery
measure: Number of patients with predefined mild-moderate-severe postoperative complications (gastric cancer surgery specific)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: In-hospital all-cause mortality
timeFrame: 30 days after surgery
measure: Compliance with ERAS items
timeFrame: 30 days after surgery
measure: Duration of hospital stay
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios de Alcoy
state: Alicante
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Don Benito-Villanueva De La Serena
country: Spain
facility: Hospital Don Benito-Villanueva de la Serena
state: Badajoz
city: Mérida
country: Spain
facility: Hospital de Mérida
state: Badajoz
city: Igualada
country: Spain
facility: Hospital de Igualada
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Tauli
state: Barcelona
city: Sant Joan d'Espi
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Santa Coloma De Gramanet
country: Spain
facility: Fundación Hospital del Espíritu Santo
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mútua Terrassa
state: Barcelona
city: Vic
country: Spain
facility: Hospital Universitario de Vic
state: Barcelona
city: Baracaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Bizkaia
city: Castellon de la Plana
country: Spain
facility: Hospital General Universitario de Castellón
state: Castellón
city: Vinaroz
country: Spain
facility: Hospital Comarcal de Vinaroz
state: Castellón
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
state: Coruña
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
state: Cádiz
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de León
state: León
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario Getafe
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Mostoles
country: Spain
facility: Hospital Rey Juan Carlos
state: Madrid
city: Mostoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quirón Madrid
state: Madrid
city: Torrejon de Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
state: Madrid
city: Inca
country: Spain
facility: Hospital Comarcal de Inca
state: Mallorca
city: Manacor
country: Spain
facility: Hospital de Manacor
state: Mallorca
city: Lorca
country: Spain
facility: Hospital Rafael Méndez
state: Murcia
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Talavera de la Reina
country: Spain
facility: Hospital Nuestra Señora del Prado
state: Toledo
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clínic Universitat de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebrón
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital General Universitario José María Morales Messeguer
city: Murcia
country: Spain
facility: Hospital Reina Sofía
city: Pontevedra
country: Spain
facility: Complejo Hospitalario y Universitario de Pontevedra
city: Salamanca
country: Spain
facility: Complejo Hospitalario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Segovia
country: Spain
facility: Complejo Asistencial de Segovia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Vitoria
country: Spain
facility: Hospital Universitario de Álava
city: Zamora
country: Spain
facility: Complejo Asistencial de Zamora
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: Infanta Leonor University Hospital, Madrid, Spain
name: Javier Ripollés-Melchor
role: STUDY_CHAIR
affiliation: Hospital General Universitario de Valencia, Spain
name: Marcos Bruna Esteban
role: STUDY_CHAIR
affiliation: Lozano Blesa University Hospital, Zaragoza, Spain
name: José M Ramírez Rodríguez
role: STUDY_CHAIR
affiliation: Hospital Universitario Río Hortega, Valladolid Spain
name: César Aldecoa
role: STUDY_CHAIR
affiliation: Infanta Leonor University Hospital, Madrid, Spain
name: Ane Abad Motos
role: STUDY_CHAIR
affiliation: Hospital Universitario Fundación Jiménez Díaz. Madrid, Spain
name: Peter Vorwald
role: STUDY_DIRECTOR
affiliation: Infanta Leonor University Hospital, Madrid, Spain
name: Gloria Crespo
role: STUDY_DIRECTOR
affiliation: Hospital Clinic of Barcelona
name: Carlos Ferrando Ortolá
role: STUDY_DIRECTOR
affiliation: Hospital Mutua Teresa, Spain
name: Joaquín Rodríguez Santiago
role: STUDY_DIRECTOR
affiliation: Servicio Navarro de Salud - Osasunbidea. Pamplona, Spain
name: José A García Erce
role: STUDY_DIRECTOR
References:
citation: Abad-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.