The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment - Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Bowel function changes after the treatment using Low anterior resection syndrome questionnaire
研究概览
简要总结
Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome.
详细描述
Colorectal cancer is common in Western countries. For thirty years rectal cancer treatment is standardized: patients are undergoing low anterior resection with mesorectal excision +/- (chemo)radiotherapy. Unfortunately around 80% of patients undergoing low anterior resection will experience complex bowel dysfunction including fecal incontinence, soiling, urgency, incomplete evacuation, fragmented defecation and impaired rectal sensation known as low anterior resection syndrome (LARS) causing a "toilet dependence" which severely affects quality of life.
Still there is no standardized treatment for LARS.
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 over 18 year
- •signed written consent
- •patients experiencing major low anterior resection syndrome
- •patients at least one year following the surgery
排除标准
- •allergy to stainless steal
- •implanted pacemaker
- •current skin infection
- •needle phobia
- •metastatic disease to the central nervous system (brain, spinal cord)
- •at the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
结局指标
主要结局
Bowel function changes after the treatment using Low anterior resection syndrome questionnaire
时间窗: 6 months
Bowel function assessment using Low anterior resection syndrome questionnaire Bowel function following low anterior resection surgery for rectal cancer will be assessed using Low anterior resection syndrome score (LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).
次要结局
未报告次要终点