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: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University

Criteria

Inclusion Criteria:

• Patients diagnosed with bladder cancer eligible for radical cystectomy and urinary diversions

• Willing to be randomized

Exclusion Criteria:

• Non-compliance and /or allergy with oral nutrition diet.

• Non-organ confined disease

• Associated comorbidities e.g. Gout and Rheumatoid arthritis

• Weight loss more than10% (with respect to usual body weight) in the past 6 months

• Hepatic dysfunction (Child-Pugh class more than B), and renal dysfunction (serum creatinine level more than3 mg/dL, hemodialysis),

• Untreated infections

• Immune disorders.

• Chronic gastrointestinal tract disease eg.crohn's disease or previous surgery.