Efficacy of preoperative immunonutrition in malnourished patients undergoing colorectal cancer surgery: a study protocol for a multicenter randomized clinical trial
Abstract
Malnutrition is a significant risk factor for postoperative complications in patients undergoing colorectal cancer surgery. Although current guidelines recommend preoperative immunonutrition for malnourished patients, its clinical benefit remains controversial. Our previous randomized clinical trial assessing immunonutrition in unselected colon cancer patients showed no reduction in infectious complications. This study aims to evaluate the efficacy of preoperative immunonutrition in reducing postoperative complications in malnourished patients undergoing colorectal cancer surgery. This multicenter, parallel, superiority, randomized clinical trial will include patients with primary colorectal cancer and Nutritional Risk Screening (NRS) 2002 score of 3–5 from eight participating institutions. Patients will be randomly assigned (1:1) to receive either preoperative immunonutrition with oral nutritional supplements (400 mL/day) containing arginine and ω-3 fatty acids for 7 days before surgery (intervention group) or a standard preoperative diet alone (control group). The primary endpoint is the rate of infectious complications within 30 days postoperatively. Secondary endpoints include overall postoperative complication rate, length of hospital stay, perioperative body weight changes, and alterations in nutritional and immune response markers (serum transferrin, prealbumin, albumin, cytokines, prostaglandin E2, high-sensitivity C-reactive protein). A sample size of 176 patients…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 176 participants or records.
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