NCT00895388撤回不适用
Effects of Structured Rehabilitation Program on Quality of Life After Surgical Treatment for Rectal Cancer- a Randomized Controlled Clinical Trial
University Hospital of North Norway2 个研究点 分布在 1 个国家开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)
研究概览
简要总结
Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Rectal cancer Surgically treated for rectal cancer Informed concent Included in national guidelines for surveillance of rectal cancer patients
排除标准
- •Older than 75 years Mentally or physically not able to participate Non curative surgical treatment
结局指标
主要结局
Quality of Life (EORTC QLQ-C30, EORTC QLQ-CR38)
时间窗: Baseline, 3, 6, 12,18 and 24 months postoperative.
Quality of LIfe (EQ 5D)
时间窗: Baseline, 3,6,12, 18 and 24.
次要结局
- ICIQ sexual function(baseline, 3,12 and 24)
- St Marks incontinence(Baseline, 3, 12 and 24)
- ICIQ Urinary function Short form(baseline,3, 12 and 24 months)
研究者
研究点 (2)
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