RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bladder cancer
- •Ability to give an informed consent
排除标准
- •Previous radiation therapy at the pelvic area
- •Ureterocutaneostomy
- •Robot-assisted surgery
结局指标
主要结局
Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)
时间窗: meassured pre-operatively + 6 and 12 weeks following surgery
Change from baseline HRQoL at 6 and 12 weeks following surgery
次要结局
- length of hospital stay(12 week follow-up)
- Time to bowel recovery(12 week follow-up)
- Body weight(preoperatively, 6 and 12 weeks postop)
- hand grip strength(pre-operatively, 6 days and 6 weeks postop)
研究者
Line Noes Lydom
Clinical nurse specialist
Rigshospitalet, Denmark