Radical Cystectomy, Nutrition and Convalescence

Not Applicable

Completed

• Conditions: Urinary Bladder Neoplasms; Bladder Cancer; Cystectomy
• Interventions: Dietary Supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

• Registration Number: NCT02238886
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-10
• Last Update Submitted: 2014-09-10
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Bladder cancer
• Ability to give an informed consent

Exclusion Criteria

• Previous radiation therapy at the pelvic area
• Ureterocutaneostomy
• Robot-assisted surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parenteral nutrition	Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi	Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
length of hospital stay	12 week follow-up
Time to bowel recovery	12 week follow-up
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

Trial Locations

Locations (1)

Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark; 🇩🇰 Copenhagen, Denmark