Radical Cystectomy, Nutrition and Convalescence

NCT ID: NCT02238886


Title
RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?
Purpose
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.
Details
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
Keywords
Quality of Life, Enteral nutrition, Nutrition Therapy, Parenteral nutrition, total
Source
Rigshospitalet, Denmark
Sponsors
Rigshospitalet, Denmark
Status
Completed
Acronym
Last Updated
09 Sep 2014
URL
Official Link
Locations
Denmark