| 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. |
| Aim: |
• 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. |
| 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. |
| Reason for International Trial: |
Post-operative complications following major abdominal surgery are common. The inclusion of enhanced recovery protocols has shown that by applying a series of perioperative measures, postoperative complications can be reduced as well as hospital stay. Current knowledge is based on small, prospective single centre studies or retrospective databases. However, there are no long-term prospective data analysing compliance with these items and their relationship to postoperative complications. Compliance with these protocols is very variable across centres and countries; the decrease in postoperative complications seems to be directly related to the complete compliance of the protocols.
To solve this problem we need concrete data in which these protocols are carried out with a high level of compliance and by the analysis of complications in a predefined way according to the European recommendations proposed by the ESA(10). Therefore, we propose a prospective observational study of one month of duration throughout Europe, analysing predefined postoperative complications within 30 days after surgery. The feasibility of this study is supported by the wide participation in observational studies carried out by the ESA, and by the wide participation in ongoing observational studies carried out by our research team. (NCT03012802). 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. 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. |