Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

Summary

Methods National audit of a 90-day prospective observational cohort in which pre-defined postoperative complications were analyzed at 30 days of follow-up in adult patients undergoing elective bariatric surgery with or without an intensified recovery program (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%)

Research Places Spanish Hospitals where this surgical intervention is carried out.

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 11%, the sample size calculation yields 460 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 be electively operated on for bariatric surgery regardless of their adherence to an ERAS intensified recovery program and the compliance level of the protocol (from 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
• Bariatric Surgery Candidate

Sponsors & Collaborators

• Sociedad Española de Cirugía de la Obesidad

  collaborator UNKNOWN

• REDGERM

  collaborator UNKNOWN

• Grupo Español de Rehabilitación Multimodal

  lead OTHER

Principal Investigators

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

• Raquel M Sanchez Santos · Complejo Hospitalario Universitario de Vigo

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

• Jaime Ruiz Tovar · Hospital Universitario Rey Juan Carlos Móstoles, Spain

• César Aldecoa · Hospital Universitario Río Hortega, Valladolid, Spain

• Carlos Ferrando-Ortolá · Hospital Clinic of Barcelona

• Ester Martín García-Almenta · Hospital Universitario Clínico San Carlos, Madrid

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

• Alfredo Abad-Gurumeta · Infanta Leonor University Hospital, Madrid, Spain

• Alejandro Suárez de la Rica · Hospital Universitario La Paz

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