Safety of early oral feeding after total laparoscopic radical gastrectomy for gastric cancer (SOFTLY-1): a single-center randomized controlled trial

Objectives: The aim of this study is to explore the safety and feasibility of early oral feeding (EOF) on short-term postoperative outcomes. Trial design: A prospective randomized non-inferiority trial. Materials and methods: From August 27, 2015 to March 31, 2017, 100 consecutive patients with gastric cancer in Xijing Hospital were recruited. Patients undergoing total laparoscopic radical gastrectomy (TLRG) received either EOF group or delayed oral feeding (DOF group). The endpoints were anastomotic leakage, the recovery of bowel function, the postoperative complications and costs. The process of randomization used a computer-generated sequence that was kept in a sealed envelope by a nurse that did not participate in the trial. None of the participants, administrators of interventions and those assessing outcomes was blinded. Results: Ultimately, 51 patients were in EOF group and 49 in DOF group, which both are comparable. The postoperative hospital stay in EOF group was significantly lower than DOF group (5.18 +/- 1.47 days vs 6.18 +/- 2.46 days, P=0.016). Furthermore, there was a trend for a reduction in the time of first flatus (10.3 hrs) and defecation (12.7 hrs) in EOF group compared to DOF group, but it was not statistically significant. Meanwhile, there were no significant differences in postoperative complications between two groups. One patient in the EOF group developed a fistula in the surgical remnant, which was recorded as other leakages; there was no difference between the two groups (P=0.582). Conclusion: EOF does not seem to be more harmful than DOF, and might significantly improve the short-term outcomes for patients receiving TLRG.