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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark
Copenhagen, Denmark
Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)
Change from baseline HRQoL at 6 and 12 weeks following surgery
Time frame: meassured pre-operatively + 6 and 12 weeks following surgery
Body weight
Change from baseline weight at 6 and 12 weeks following the date of surgery
Time frame: preoperatively, 6 and 12 weeks postop
hand grip strength
Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery
Time frame: pre-operatively, 6 days and 6 weeks postop
length of hospital stay
Time frame: 12 week follow-up
Time to bowel recovery
Time frame: 12 week follow-up
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