ISRCTN25945941已完成不适用
Prospective randomised double-blind placebo-controlled crossover study of sacral nerve stimulation in patients with severe rectal evacuatory dysfunction and rectal hyposensitivity
Queen Mary, University of London (UK)0 个研究点目标入组 20 人开始时间: 2011年7月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients aged 18 - 65 years, either sex
- •2. Incomplete and/or assisted evacuation
- •3. Idiopathic (no rectal surgery, no spinal and overt neurological history)
- •4. Failed maximal conventional therapy
- •5. Normal colonic transit and rectal diameter
- •6. No significant mechanical obstructive abnormality on proctography
- •7. Unable to evacuate greater than 60% contrast in 3 minutes
- •8. Rectal hyposensation (based 2/3 abnormal values of first constant sensation [FCS], defecatory desire [DDV] and maximum tolerable volume [MTV] to balloon distension)
排除标准
- •1. Inability to provide informed consent
- •2. Severe concomitant medical conditions precluding randomisation to operative treatment
- •3. Neurological diseases such as diabetic neuropathy, multiple sclerosis and parkinson's disease
- •4. Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers
- •5. Congenital anorectal anomalies or absence of native rectum due to surgery
- •6. Present evidence of external full thickness rectal prolapse
- •7. Previous rectal surgery (rectopexy/resection) done less than 12 months ago (24 months for cancer)
- •8. Stoma in situ
- •9. Chronic bowel disease such as inflammatory bowel disease, chronic uncontrolled diarrhoea
- •10. Anatomical limitations that would prevent successful placement of electrodes
- •11. Pregnancy or intention to become pregnant
- •12. Previous experience of sacral nerve stimulation (SNS)
研究者
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