Clinical Trial: Radical Cystectomy, Nutrition and Convalescence

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIE

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 Summary:

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.


Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: 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 ]

Change from baseline HRQoL at 6 and 12 weeks following surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Body weight [ Time Frame: preoperatively, 6 and 12 weeks postop ]
    Change from baseline weight at 6 and 12 weeks following the date of surgery
  • hand grip strength [ Time Frame: 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
  • length of hospital stay [ Time Frame: 12 week follow-up ]
  • Time to bowel recovery [ Time Frame: 12 week follow-up ]


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: September 5, 2014
Date Started: May 2012
Date Completion:
Last Updated: September 10, 2014
Last Verified: September 2014