PURPOSE: To compare postoperative complications in patients with or without preoperative immunonutrition before cystectomy. METHODS: A prospective, multicenter, pilot, case-control study was conducted during 6 months. Patients with 7-day preoperative immunonutrition were prospectively included and compared with a retrospective, matched control group without immunonutrition. Early complication rates and the length of hospital stay were analyzed. The bilateral type I error was <0.05; the power was 90%. Thirty patients in each group were required. RESULTS:Thirty patients were included in each group, on a comparable basis. In the immunonutrition group, fewer postoperative complications (40 vs. 76.7%; p = 0.008), less paralytic ileus at D7 (6.6 vs. 33.3%; p = 0.02), fewer infections (23.3 vs. 60%; p = 0.008), and in particular less pyelonephritis (16.7 vs. 46.7%; p = 0.03) occurred. Clavien's grades for complications were higher in the control group (p = 0.04). Mortality, pulmonary embolism, anastomotic fistulae, and wound dehiscence were similar between two groups. The length of stay was reduced by 3 days in the immunonutrition group. CONCLUSIONS: In this pilot case-control study, immunonutrition is associated with a decrease in postoperative complications, urinary tract infections, Clavien's grade for complications, and paralytic ileus in patients undergoing cystectomy for bladder cancer. Prospective randomized placebo control studies are needed to confirm these promising results.
RCT Entities:
PURPOSE: To compare postoperative complications in patients with or without preoperative immunonutrition before cystectomy. METHODS: A prospective, multicenter, pilot, case-control study was conducted during 6 months. Patients with 7-day preoperative immunonutrition were prospectively included and compared with a retrospective, matched control group without immunonutrition. Early complication rates and the length of hospital stay were analyzed. The bilateral type I error was <0.05; the power was 90%. Thirty patients in each group were required. RESULTS: Thirty patients were included in each group, on a comparable basis. In the immunonutrition group, fewer postoperative complications (40 vs. 76.7%; p = 0.008), less paralytic ileus at D7 (6.6 vs. 33.3%; p = 0.02), fewer infections (23.3 vs. 60%; p = 0.008), and in particular less pyelonephritis (16.7 vs. 46.7%; p = 0.03) occurred. Clavien's grades for complications were higher in the control group (p = 0.04). Mortality, pulmonary embolism, anastomotic fistulae, and wound dehiscence were similar between two groups. The length of stay was reduced by 3 days in the immunonutrition group. CONCLUSIONS: In this pilot case-control study, immunonutrition is associated with a decrease in postoperative complications, urinary tract infections, Clavien's grade for complications, and paralytic ileus in patients undergoing cystectomy for bladder cancer. Prospective randomized placebo control studies are needed to confirm these promising results.
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