Effects of Preoperative Use of an Immune-Enhancing Diet on Postoperative Complications and Long-Term Outcome: A Randomized Clinical Trial in Colorectal Cancer Surgery in Japanese Patients

Abstract

Background: Despite recent advances in surgical techniques and perioperative management, postoperative infectious complications remain a problem in surgical patients. We performed a prospective randomized clinical trial to examine the effects of preoperative Immune Enhancing Diets (IEDs) on postoperative complications in Japanese patients who underwent curative colorectal cancer surgery. This study was also designed to evaluate the optimal dose of preoperative IEDs for the patients without malnutrition. Finally, we analyzed recurrence free survival (RFS) and disease-specific survival (DSS) after surgery in patients who did and did not receive IEDs preoperatively. Material and Methods: This was a prospective, randomized clinical trial conducted at the Department of Surgery, National Defense Medical College, from October 2002 to October 2005. The 88 patients undergoing colorectal surgery were enrolled and were randomly divided into 3 groups. The high- (High, N=26) and low- (Low, N=31) dose groups received normal food and, respectively, 750ml/day or 250ml/ day of IEDs for 5 days before the operation. The primary endpoint was the rates of surgical site infection (SSI) and non- infectious complications. We also evaluated the RFS and DSS rate, respectively. Results: The patients were followed for 77±10 months (9-133 months) after surgery. Incisional SSI rates in the IEDs (High and Low) groups were significantly lower than in the Control group. (0%*, 0%* and 17%) (*P<0.01 vs. Control) The incidences of the infections not involving the surgical site (non-SSI) and the lengths of hospital stay were similar among the three groups. No significant differences were observed in RFS or DSS. Conclusion: In Japanese patients undergoing colorectal cancer surgery, preoperative IEDs significantly reduced the rate of incisional SSI as compared with the control group. Very interestingly, in Japanese patients, preoperative 250ml/day IED intake may be adequate for colorectal cancer patients without malnutrition. However, with regard to the long term outcome, beneficial effects of preoperative IEDs are not evident.