Enhanced Recovery Pathways, Patient-reported Outcomes and Return to Intended Oncological Therapy After Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 3).

BACKGROUND Enhanced Recovery After Surgery (ERAS) is a multimodal and multifactorial approach to the optimization of perioperative management. In order to modify and improve the response to surgery-induced trauma, the program relies on a series of evidence-based items related to pre-, intra- and post-operative care. Several meta-analyses on ERAS showed a significant reduction of morbidity rates and length of stay after colorectal surgery. However, program implementation outside clinical trials is still extremely variable, as the necessary multidisciplinary involvement makes the program vulnerable to various areas of failure, that explain the great variation in adherence rates to program items.

During the early phase of program implementation, adherence rate to program items rarely goes beyond 50%, needing to reach at least 70% in order to significantly improve results (faster recovery and reduced morbidity). Recent cohort studies reported a mean adherence rate to ERAS items between 63 and 75%. In other studies, adherence to ERAS items was higher, reaching up to 90%. Moreover, a clear and significant dose-effect curve between adherence rate to ERAS program items and early outcomes was demonstrated, and recent evidence deriving from retrospective studies suggests that ERAS programs may also offer a definite advantage over long-term survival after colorectal resection for malignancy. While many studies to date have focused on early outcomes (i.e. earlier return of bowel function, lower complication rates, and/or shorter length of inpatient stay), for the majority of oncologic operations, however, postoperative recovery carries the additional demand of returning the patient to adjuvant oncologic therapies. It is still unclear if ERAS program could improve the failure to "return to intended oncologic therapy" (RIOT) after cancer surgery due to complications and lingering poor performance status, that is strongly associated with worse oncologic outcomes, including shortened overall survival. Measuring patient-reported outcomes (PROs) addresses the gap in enhanced recovery assessment by incorporation of patient-centered quality into our global assessment of outcomes. Taken together, these data establish a paradigm for association of perioperative medical care to long-term oncologic outcomes-revealing how the perioperative care team's actions over a relatively short number of days and hours around the time of a cancer surgery can improve cancer-specific survival. The concept is that various perioperative techniques, protocols, and agents will blunt the patient's perioperative stress response, reduce complications, and improve functional recovery after surgery. Together, these effects allow more people to RIOT in a more timely fashion and in a more complete way. To the extent that the combination of preservation of immune competence and more reliable return to adjuvant therapies then reduce recurrence rates, longer and more meaningful survivals may be achieved.

Therefore, the Italian Colorectal Anastomotic Leakage study group planned this study to prospectively evaluate the impact of adherence to ERAS program items after colorectal resections on PRO in the whole population and on failure to RIOT for malignant disease.

Outcome measures

1. Preoperative risk factors (age, gender, obesity, nutritional status, diabetes, cardiovascular disease, chronic liver disease, renal failure, inflammatory bowel disease, perioperative steroid therapy, ASA class I-II vs III, SARS-CoV-2 infection)
2. Operative parameters (approach, procedure, anastomotic technique, length of operation, pTNM stage)
3. Adherence to ERAS program items