Safety of early oral feeding after total laparoscopic radical gastrectomy for gastric cancer (SOFTLY): Study protocol for a randomized controlled trial.
BACKGROUND
Gastric cancer is the third most common cause of cancer-related deaths and has the fifth highest incidence worldwide, especially in eastern Asia, central and Eastern Europe, and South America. Currently, surgery is the only curative treatment for gastric cancer; however, there is an increasing trend toward laparoscopic radical gastrectomy. Early oral feeding (EOF) has been shown to benefit clinical outcomes compared with open gastrectomy under conditions of enhanced recovery after surgery. There are a lack of guidelines and evidence for the safety and feasibility of EOF in patients undergoing laparoscopic radical gastrectomy. Thus, a prospective randomized trial is warranted.


METHODS/DESIGN
The EOF after total laparoscopic radical gastrectomy (SOFTLY) study is a single-center, parallel-arm, non-inferiority randomized controlled trial which will enroll 200 patients who are pathologically diagnosed with gastric cancer and undergo laparoscopic radical gastrectomy. The primary endpoint, incidence of anastomotic leakage, is based on 1.9% in the control group in the CLASS-01 study. The patients will be randomized (1:1) into two groups: the EOF group will receive a clear liquid diet on post-operative day 1 (POD1) and the delayed oral feeding (DOF) group will receive a clear liquid diet on post-operative day 4 (POD4). The demographic and pathologic characteristics will be recorded. Total and oral nutritional intake, general data, total serum protein, serum albumin, blood glucose, and temperature will be recorded before surgery and at the time of hospitalization. Adverse events will also be recorded. The occurrence of post-operative fistulas, including anastomotic leakage, will be recorded as the main severe post-operative adverse event and represent the primary endpoint.


DISCUSSION
The safety and feasibility of EOF after gastrectomy has not been established. The SOFTLY trial will be the first randomized controlled trial involving total laparoscopic radical gastrectomy, in which the EOF group (POD1) will be compared with the DOF group (POD4). The results of the SOFTLY trial will provide data on the safety and feasibility of EOF after total laparoscopic radical gastrectomy.


TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR-IOR-15007660 . Registered on 28 December 2015. The study has full ethical and institutional approval.
['Wang|Quan|Q|', 'Guo|Bo-Yang|BY|', 'Zhao|Qing-Chuan|QC|', 'Yan|Zun-Dong|ZD|', 'Shang|Li-Feng|LF|', 'Yu|Juan|J|', 'Ji|Gang|G|']
D000293:Adolescent D000328:Adult D000368:Aged D005743:Gastrectomy D006801:Humans D010535:Laparoscopy D008875:Middle Aged D011183:Postoperative Complications D011446:Prospective Studies D016032:Randomized Controlled Trials as Topic D013274:Stomach Neoplasms D055815:Young Adult
Early oral feeding Gastric cancer Anastomotic leakage Post-operative fistula Enhanced recovery after surgery (ERAS) Totally laparoscopic gastrectomy