Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- changes in LARS score
研究概览
简要总结
A randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.
详细描述
Patients will undergo anal physiological assessment and will then be randomized to either treatment arm. The first 12 weeks they will be optimized in the conservative treatment of their bowel function before beginning active treatment with TAI or PNE. After 8 and 4 weeks respectively, the treatment will stop and they will have a period of 4 weeks back on optimized conservative treatment before beginning active treatment in the other active arm.
Detailed records of bowel, micturition and sexual function and QoL will be obtained at regular intervals during the entire trial fase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Low anterior resection for rectal cancer between May 2001 and May 2011
排除标准
- •Non-radical resection
- •metastatic disease
- •Chemotherapy
- •Radiotherapy
- •Previously treated for another cancer
- •Dementia or other mental retardation/severe mental disease
- •Inability to read and understand the Danish language
- •Recurrent disease
研究组 & 干预措施
PNE first
patients randomised to start with PNE stimulation over 4 weeks. Then the stimulator will be removed and after a wash out period of 4 weeks they will be trained in transanal irrigation
干预措施: Percutaneous nerve evaluation (Procedure)
TAI first
Patients randomised to start with transanal irrigation treatment in 8 weeks, thereafter a wash out period of 4 weeks before being implanted with a neuro stimulator
干预措施: Percutaneous nerve evaluation (Procedure)
结局指标
主要结局
changes in LARS score
时间窗: baseline, 12, 16, 20, 24 and 28 weeks
A symptom score ranging from 0 to 42 points calculated on the basis of bowel function
次要结局
- Incontinence(baseline, 12, 16, 20, 24 and 28 weeks)
- Sexual function(baseline, 12, 16, 20, 24 and 28 weeks)
- Patient Satisfaction(baseline, 12, 16, 20, 24 and 28 weeks)
- Bladder function(baseline, 12, 16, 20, 24 and 28 weeks)