Radical Cystectomy, Nutrition and Convalescence

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02238886
• Date of registration: 05/09/2014
• Prospective Registration: No
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Radical Cystectomy, Nutrition and Convalescence
• Scientific title: RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?
• Date of first enrolment: May 2012
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02238886
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- Bladder cancer

- Ability to give an informed consent

Exclusion Criteria:

- Previous radiation therapy at the pelvic area

- Ureterocutaneostomy

- Robot-assisted surgery



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystectomy

Urinary Bladder Neoplasms

Bladder Cancer

Intervention(s)

Dietary Supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

Primary Outcome(s)

Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire) [Time Frame: meassured pre-operatively + 6 and 12 weeks following surgery]

Secondary Outcome(s)

length of hospital stay [Time Frame: 12 week follow-up]

hand grip strength [Time Frame: pre-operatively, 6 days and 6 weeks postop]

Time to bowel recovery [Time Frame: 12 week follow-up]

Body weight [Time Frame: preoperatively, 6 and 12 weeks postop]

Secondary ID(s)

H-2-2011-114

Source(s) of Monetary Support

Please refer to primary and secondary sponsors