Effect of immunonutrition on postoperative infectious complications and survival after colon cancer surgery: long-term follow up of randomized clinical trial
Abstract
Background: A previous randomized clinical trial (RCT) in patients undergoing elective colon cancer surgery showed that preoperative immunonutrition did not reduce short-term postoperative infectious complications. This study reports the long-term follow-up of that RCT, evaluating the impact of preoperative immunonutrition and the association of postoperative infectious complications with survival outcomes.
Methods: This secondary analysis used prospectively collected survival data from a prior RCT in which patients were randomized 1:1 to receive either preoperative immunonutrition plus a normal diet or a normal diet alone (control) for 7 days before surgery. The primary endpoints were disease-free survival (DFS) and overall survival (OS). Survival outcomes were analysed in relation to randomized treatment allocation and clinicopathological variables, including postoperative complications, using Kaplan-Meier methods and Cox proportional hazards models.
Results: A total of 161 patients were included, with 79 randomized to immunonutrition and 82 to control. The mean age was 65.3 years, and 65.8% were male, with similar baseline characteristics between groups. After a median follow-up of 57 months (range 4-65), preoperative immunonutrition did not affect 5-year DFS (80% versus 86% in controls; P = 0.474) or 5-year OS (88% versus 90%; P = 0.761). In contrast, postoperative infectious complications were associated with lower 5-year OS (74% versus 92%; P = 0.013) and showed a…
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: 161 participants or records.
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