Radical Cystectomy, Nutrition and Convalescence

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?

Conditions
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Urinary Bladder Neoplasms, Cystectomy, Bladder Cancer

Intervention / Treatment
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* Dietary Supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bladder cancer Ability to give an informed consent Exclusion Criteria: Previous radiation therapy at the pelvic area Ureterocutaneostomy Robot-assisted surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenteral nutrition<br>Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition | Dietary Supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi<br> <br> |
| No Intervention: Standard treatment<br>patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | pre-operatively, 6 days and 6 weeks postop | 
| length of hospital stay |  | 12 week follow-up | 
| Time to bowel recovery |  | 12 week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Enteral nutrition, Nutrition Therapy, Parenteral nutrition, total