Bladder Cancer, Cystectomy, Urinary Bladder Neoplasms
Conditions
Keywords
Quality of Life, Enteral nutrition, Nutrition Therapy, Parenteral nutrition, total
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTParenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bladder cancer * Ability to give an informed consent
Exclusion criteria
* Previous radiation therapy at the pelvic area * Ureterocutaneostomy * Robot-assisted surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire) | meassured pre-operatively + 6 and 12 weeks following surgery | Change from baseline HRQoL at 6 and 12 weeks following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | preoperatively, 6 and 12 weeks postop | Change from baseline weight at 6 and 12 weeks following the date of surgery |
| hand grip strength | pre-operatively, 6 days and 6 weeks postop | Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery |
| length of hospital stay | 12 week follow-up | — |
| Time to bowel recovery | 12 week follow-up | — |
Countries
Denmark
Outcome results
None listed