Postoperative Complications Clinical Trial
Official title:
Postoperative Outcomes Within/Without an Enhanced Recovery After Surgery Protocol in Colorectal Surgery Across Europe
Methods
30 days European Multicentre observational cohort study of postoperative complications
following elective colorectal surgery within any compliance of an ERAS protocol (including
patients with 0 compliance) in a participating hospital during the 30-day cohort period with
a planned overnight stay.
Research sites
Hospitals across Europe with an elective colorrectal surgical service
Objective
To provide detailed data describing post-operative complications and associated mortality To
provide detailed data describing adherence to ERAS protocol and its association to morbidity
and length of stay.
To provide detailed information on the influence of the volume of patients undergoing surgery
on each center and postoperative complications censured at 30 days after surgery.
Inclusion criteria All adult patients (aged ≥18 years) undergoing elective colorectal surgery
during the 30-day study period.
Statistical analysis Number of patients: All eligible patients undergoing elective colorectal
surgery during the study month in European participating hospitals.
Univariate analysis will be used to test factors (patient, surgical, and ERAS related)
associated with surgical complications, length of stay (LOS) and in-hospital death. Single
and multi-level logistic regression models will be constructed to identify factors
independently associated with these outcomes and to adjust for differences in confounding
factors. A stepwise approach will be used to enter new terms. A single final analysis is
planned at the end of the study.
Summary statistics with post hoc Bonferroni corrections will be used to assess possible dose-
response dependence in percentage of patients with postoperative complications and LOS.
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 colorectal
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 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, our 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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