NCT02238886

Radical Cystectomy, Nutrition and Convalescence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder Neoplasms
• Cystectomy
• Bladder Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-09-12
• Last updated: 2014-09-12

Locations

1 site across 1 country: Denmark