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

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.

Conditions

• Perioperative Care
• Postoperative Complications
• Gastric Cancer

Sponsors & Collaborators

• Grupo Español de Rehabilitación Multimodal

  lead OTHER

Principal Investigators

• Javier Ripollés-Melchor · Infanta Leonor University Hospital, Madrid, Spain

• Marcos Bruna Esteban · Hospital General Universitario de Valencia, Spain

• José M Ramírez Rodríguez · Lozano Blesa University Hospital, Zaragoza, Spain

• César Aldecoa · Hospital Universitario Río Hortega, Valladolid Spain

• Ane Abad Motos · Infanta Leonor University Hospital, Madrid, Spain

• Peter Vorwald · Hospital Universitario Fundación Jiménez Díaz. Madrid, Spain

• Gloria Crespo · Infanta Leonor University Hospital, Madrid, Spain

• Carlos Ferrando Ortolá · Hospital Clinic of Barcelona

• Joaquín Rodríguez Santiago · Hospital Mutua Teresa, Spain

• José A García Erce · Servicio Navarro de Salud - Osasunbidea. Pamplona, Spain

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-22

Primary Completion

2020-02-22

Completion

2020-03-22

Countries

• Spain

Study Locations