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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral nutrition | Experimental | Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition |
|
| Standard treatment | No Intervention | patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | meassured pre-operatively + 6 and 12 weeks following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Change from baseline weight at 6 and 12 weeks following the date of surgery | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| pre-operatively, 6 days and 6 weeks postop |
| length of hospital stay | 12 week follow-up |
| Time to bowel recovery | 12 week follow-up |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |