A Randomized Controlled Phase Iii Trial To Evaluate The Effect Of Preoperative Enteral Immunonutrition On The Surgical Site Infection Alter Total Gastrectomy (Ogsg0507)

74 Background: To investigate the effect of preoperative enteral immunonutrion on the incidence of surgical site infection (SSI) after total gastrectomy for gastric cancer, we conducted a prospective randomized controlled trial. Methods: Eligibility criteria included: (1) histologically proven adenocarcinoma of stomach, (2) scheduled total gastrectomy, (3) aged less than 80 years, (4) not malnourished, (5) possible to ingest liquid diet, (6) written informed consent. Eligible patients (pts) wereassigned to the immunonutrition (I) group or the control (C) group. In the C group pts freely accessed to regular diet until surgery. In the I group, pts were supplemented with 1,000 ml/day of immunonutrient enriched with arginine, omega-3 fatty acids and RNA (Impact) in addition to the regular diet for 5 days before surgery. The primary endpoint was the incidence of SSI and the secondary endpoints were other infectious complications and serum CRP level on POD 3 or 4. Results: From 02/2004 to 12/2009, 240 gastric cancer patients (pts) who underwent gastric surgery were enrolled. 125 pts assigned to the I group and 115 pts assigned to the C group. Age, sex, body weight, serum albumin and general nutritional status were well balanced between the two groups. 223 pts underwent total gastrectomy, 6 pts proximal gastrectomy, 4 pts distal gastrectomy, and 7 pts simple laparotomy. In terms of tumor status, there were no significant difference between the groups in histological type, T stage, and lymph node metastasis. 104 of 125 pts assigned to the I group tolerated a daily intake 1,000 ml of Impact for 5 days. The incidence of SSI was 26 (20.8%) in the I group and 24 (20.9%) in the C group (R.R: 1.00, 95% C.I: 0.61-1.63). Postoperative morbidity was 36 (28.8%) in the I group and 30 (26.1%) in the C group. There was no difference in days of hospital stay after surgery between the groups. Conclusions: The oral administration of immunonutrient for 5 days before surgery did not contributed to the reduction of infectious complications after total gastrectomy in gastric cancer pts. No significant financial relationships to disclose.