Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy
Status:
Unknown status
Trial end date:
2017-10-30
Target enrollment:
Participant gender:
Summary
This is a randomised double-blinded placebo-controlled phase IV trial with two parallel
treatment groups receiving either immune nutrition diet (IND) or conventional diet for 2weeks
peri-radical cystectomy. Patients will be stratified according to the gender, body mass
index, and the type of urinary diversion (orthotopic neobladder or ileal conduit). The
primary end-point is to determine, in intention to treat analysis, the influence of IND on
90-day postoperative morbidity. Secondary study end-points will be the effect of IND on
infectious as well as non-infectious complications over 90 days, compliance and adverse
effects of IND. Finally, an ancillary study will be performed to evaluate whether the IND
costs could counterbalance, by its benefits, the health care costs.It is envisaged to finish
patients' recruitment within 24 months