ERas and COLorectal endoscopic surgery: an Italian society for endoscopic surgery and new technologies (SICE) national report

Background Several reports demonstrated a strong association between the level of adherence to the protocol and improved clinical outcomes after surgery. However, it is difficult to obtain full adherence to the protocol into clinical practice and has still not been identified the threshold beyond which improved functional results can be reached. Methods The ERCOLE (ERas and COLorectal Endoscopic surgery) study was as a cohort, prospective, multi-centre national study evaluating the association between adherence to ERAS items and clinical outcomes after minimally invasive colorectal surgery. The primary endpoint was to associate the percentage of ERAS adherence to functional recovery after minimally invasive colorectal cancer surgery. The secondary endpoints of the study was to validate safety of the ERAS programme evaluating complications' occurrence according to Clavien-Dindo classification and to evaluate the compliance of the Italian surgeons to each ERAS item. Results 1138 patients were included. Adherence to the ERAS protocol was full only in 101 patients (8.9%), > 75% of the ERAS items in 736 (64.7%) and > 50% in 1127 (99%). Adherence to > 75% was associated with a better functional recovery with 90.2 +/- 98.8 vs 95.9 +/- 33.4 h (p = 0.003). At difference, full adherence to the ERAS components 91.7 +/- 22.1 vs 92.2 +/- 31.6 h (p = 0.8) was not associated with better recovery. Conclusions Our results were encouraging to affirm that adherence to the ERAS program up to 75% could be considered satisfactory to get the goal. Our study could be considered a call to simplify the ERAS protocol facilitating its penetrance into clinical practice

Continuous vs intermittent Non-Invasive blood pressure MONitoring in preventing postoperative organ failure (niMON): study protocol for an open-label, multicenter randomized trial

Background: Blood pressure has become one of the most important vital signs to monitor in the perioperative setting. Recently, the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) recommended, with low level of evidence, continuous monitoring of blood pressure during the intraoperative period. Continuous monitoring allows for early detection of hypotension, which may potentially lead to a timely treatment. Whether the ability to detect more hypotension events by continuous noninvasive blood pressure (C-NiBP) monitoring can improve patient outcomes is still unclear. Here, we report the rationale, study design, and statistical analysis plan of the niMON trial, which aims to evaluate the effect of intraoperative C-NiBP compared with intermittent (I-NiBP) monitoring on postoperative myocardial and renal injury. Methods: The niMon trial is an investigator-initiated, multicenter, international, open-label, parallel-group, randomized clinical trial. Eligible patients will be randomized in a 1:1 ratio to receive C-NiBP or I-NiBP as an intraoperative monitoring strategy. The proportion of patients who develop myocardial injury in the first postoperative week is the primary outcome; the secondary outcomes are the proportions of patients who develop postoperative AKI, in-hospital mortality rate, and 30 and 90 postoperative days events. A sample size of 1265 patients will provide a power of 80% to detect a 4% absolute reduction in the rate of the primary outcome. Conclusions: The niMON data will provide evidence to guide the choice of the most appropriate intraoperative blood pressure monitoring strategy. Clinical trial registration: Clinical Trial Registration: NCT05496322, registered on the 5th of August 2023