Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER4)

Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER .4)

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Gastric Cancer; 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 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

• Study Type: Observational
• Enrollment (Anticipated): 861

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain
    • Hospital General Universitario de Alicante
  • 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
  • Lleida, Spain
    • Hospital Universitario Arnau de Vilanova
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Clínico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain
    • Hospital de La Princesa
  • Murcia, Spain
    • Hospital Reina Sofía
  • Murcia, Spain
    • Hospital General Universitario José María Morales Messeguer
  • Pontevedra, Spain
    • Complejo Hospitalario y Universitario de Pontevedra
  • Salamanca, Spain
    • Complejo Hospitalario de Salamanca
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla
  • Segovia, Spain
    • Complejo Asistencial de Segovia
  • 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
  • Zamora, Spain
    • Complejo Asistencial de Zamora
  • Zaragoza, Spain
    • Hospital Clinico Universitario Lozano Blesa
  • 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
    • Don Benito-Villanueva De La Serena, Badajoz, Spain
      • Hospital Don Benito-Villanueva de la Serena
    • Mérida, Badajoz, Spain
      • Hospital de Mérida
  • Barcelona
    • Igualada, Barcelona, Spain
      • Hospital de Igualada
    • Sabadell, Barcelona, Spain
      • Hospital Universitario Parc Taulí
    • Sant Joan d'Espi, Barcelona, Spain
      • Hospital de Sant Joan Despi Moises Broggi
    • Santa Coloma De Gramanet, Barcelona, Spain
      • Fundación Hospital del Espíritu Santo
    • Terrassa, Barcelona, Spain
      • Hospital Mutua Terrassa
    • 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
    • Vinaroz, Castellón, Spain
      • Hospital Comarcal de Vinaroz
  • Coruña
    • A Coruna, Coruña, Spain
      • Complejo Hospitalario Universitario de A Coruña
  • Cádiz
    • Cadiz, Cádiz, Spain
      • Hospital Universitario Puerta del Mar
  • León
    • Leon, León, Spain
      • Complejo asistencial universitario de Leon
  • Madrid
    • Alcalá de Henares, Madrid, Spain
      • Hospital Universitario Príncipe de Asturias
    • Alcorcón, Madrid, Spain
      • Hospital Universitario Fundación Alcorcón
    • 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
  • Mallorca
    • Inca, Mallorca, Spain
      • Hospital Comarcal de Inca
    • Manacor, Mallorca, Spain
      • Hospital de Manacor
  • Murcia
    • Lorca, Murcia, Spain
      • Hospital Rafael Méndez
  • Málaga
    • Marbella, Málaga, Spain
      • Hospital Costa Del Sol
  • Navarra
    • Pamplona, Navarra, Spain
      • Complejo Hospitalario de Navarra
  • Toledo
    • Talavera de la Reina, Toledo, Spain
      • Hospital Nuestra Señora del Prado
  • Valencia
    • Manises, Valencia, Spain
      • Hospital de Manises

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age undergoing gastric resection surgery due to cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gastric Surgery; Adult patients undergoing elective gastric surgery for cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital all-cause mortality	The number and percentage of deaths within 30 days of surgery will be reported for each surgical category	30 days after surgery
Compliance with ERAS items	Overall compliance will be calculated as the average of all pre- and intraoperative ERAS adapted elements, as specified in the ERAS society colon and rectal guidelines ERAS patients' guideline compliance will be categorised into quartiles	30 days after surgery
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

Collaborators and Investigators

• Sponsor: Grupo Español de Rehabilitación Multimodal
• Investigators: 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 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

Publications and helpful links

General Publications

• 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.

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 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 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: REDGERM05

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