NCT04246775已完成不适用
Low Anterior Resection Syndrome and Rectal Irrigation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- SF12
研究概览
简要总结
Prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (LARS) in terms of quality of life and bowel function.
详细描述
Aims: To assess if rectal irrigation improves patient symptoms and quality of life in patients with LARS and to see if the treatment is acceptable to patients.
Methods: This is a mixed methods evaluation study on functional outcomes in patients who have undergone anterior resection for rectal neoplasia and who have had bowel continuity restored between Jan 2009 and Jan 2014. Those patients deemed to have LARS who consent to participation in the study will be offered rectal irrigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •patients who have undergone anterior resection for rectal neoplasia, patients who have had restored bowel continuity
- •LARS score of >20 (defined LARS syndrome)
- •patients > 18 years of age.
排除标准
- •previous use of rectal irrigation
- •patients who are unable to give informed consent
- •patients who are not physically capable of performing the treatment in their home
结局指标
主要结局
SF12
时间窗: pre intervention and 6 months post
quality of life
次要结局
- treatment acceptability questionnaire(post training for treatment and 6 months post treatment)
- St Marks Faecal incontinence score(pre intervention and 6 months post)
- EORTC(pre intervention and 6 months post)
- Low anterior resection score(pre intervention and 6 months post)
研究者
研究点 (2)
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