Studying Preoperative Immunonutrition to Reduce Complications and Improve Immune Response After Cystectomy Surgery

What this Trial Is About

Researchers are evaluating the effect of preoperative oral immunonutrition IN on reducing post-operative complications in patients undergoing cystectomy, a surgery to remove the bladder. This multicenter randomized controlled trial aims to assess whether IN can improve outcomes like infections after surgery and to develop a method to identify patients who would benefit most from this nutrition. The study addresses the high complication rates associated with cystectomy and the role of malnutrition as a risk factor. Participants are randomly assigned to one of two groups one receives seven days of oral immunonutrition before surgery, and the other follows standard care without IN. The immunonutrition supplement, Oral Impact, is taken three times daily for seven days before the operation. The trial compares these approaches to see if preoperative IN reduces complications and improves immune response. During the study, researchers will monitor infectious complications within 30 days after surgery as the primary outcome. Secondary outcomes include overall complication rates at 30 and 90 days, mortality rates, complication-free survival, and treatment compliance. Participants will be assessed through clinical evaluations and compliance tracking from 30 days before surgery through hospital admission. The total participation duration varies depending on surgery timing and follow-up assessments.

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)