Postoperative Complications Clinical Trial
Official title:
Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol POWER3
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.
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 elective bariatric surgery 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 bariatric 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
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