The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

This study was a single-institution, randomized controlled clinical trial to test the superiority of Enhanced Recovery After Surgery (ERAS) protocol for patients with pancreaticoduodenectomy (PD). This study will be conducted on adult patients who are planning to undergo pancreaticoduodenectomy for the treatment of periampullary disease for 12 months after the start of the study. Based on the results of the previous study which choose the functional recovery date as a primary outcome (control group; 9.0 ± 4.3 days, intervention group; 7.6 ± 4.3 days), a total of 334 patients (167 patients in each group) will be enrolled when calculated with power 0.8, α = 0.05, a two-tailed test, and a 10% withdrawal rate. Investigators plan to randomize patients covered by the existing ERAS program to the control group and patients covered by the full ERAS protocol to the experimental group. Investigators plan to observe the clinical outcomes up to 3 months after surgery. The primary outcome is the functional recovery date, and secondary outcomes are the postoperative complication rate, postoperative mortality, and readmission rate. All subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set was not defined differently.