"Ultra" E.R.A.S. in laparoscopic colectomy for cancer: discharge after the first flatus? A prospective, randomized trial.

Abstract

Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications. The aim of this study was to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on postoperative day 2, so long as the first flatus has passed and in the absence of complication-related symptoms. This study was a non-inferiority, open-label, single-center, prospective, randomized study comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4, respectively. Seven hundred and sixty-five patients with resectable non-metastatic colonic cancer were analyzed: 384 patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S. Primary end-point was mortality; secondary end-points were morbidity, readmission and reoperation rate. Limitations are: it is a single-center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non-compliance" may be considered arbitrary. Mortality was 0.89% in "Ultra" E.R.A.S. group and 0.59% in Classic E.R.A.S. (p=0.571). Morbidity was 34.1% for "Ultra" E.R.A.S. arm and 35.4% for Classic E.R.A.S. (p=0.753). Readmissions were 5.6% for "Ultra" E.R.A.S. and 5.9% for Classic E.R.A.S. (p=0.359). Reoperation rate was 3.8% for "Ultra" ERAS and 4.7% for Classic E.R.A.S. (p=0.713). Multivariate regression analyses using Cox's proportional hazard model showed that mortality (primary end-point), morbidity, reoperation and readmission (secondary end-points) were not significantly influenced by the two different perioperative regimens; conversely, the global cost of "Ultra" E.R.A.S. regimen was more economically effective. "Ultra" E.R.A.S. showed to be safe, actual and effective; discharge on postoperative day 2 after the first flatus passage, in the absence of complication-related symptoms, should be actively considered in a modern, multidisciplinary, multimodal laparoscopic management of colonic cancer.