Bladder Cancer Clinical Trial
Official title:
RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?
The purpose of this study is to determine whether a goal directed nutritional intervention
can reduce the convalescence period for patients undergoing radical cystectomy (RC).
The aim is to examine the effect on quality of life of a standard nutritional strategy of
resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery
versus a goal-directed nutritional intervention combining oral intake and parenteral
nutrition, in patients undergoing RC.
The study is a randomized controlled trial. Inclusion criteria: Bladder cancer, ability to
give an informed consent. Exclusion criteria: Previous radiation therapy at the pelvic area,
ureterocutaneostomy or robot-assisted surgery. The intervention aims to secure that 75% of
the patient's total energy and protein needs are met during hospitalization.
Primary outcome: Quality of Life, using the EORTC QLQ-C30 and BLM30 questionnaire. Secondary
outcomes: Body-weight, Hand Grip strength, biochemical measures, length of hospital stay,
time to bowel recovery. The follow-up period is 12 weeks. Statistical analysis is performed
in collaboration with a statistician.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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