Percutaneous Tibial Nerve Stimulation for Chronic Anal Fissure - a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Healing rate
研究概览
简要总结
Chronic anal fissure rarely heals spontaneously. About 50% heal on administration om topical muscle relaxants (e.g. diltiazem) and/or injection of Botulinum toxin, but for the remainder of patients surgery (with lateral internal sphincterotomy or fissurectomy) with subsequent risks of anal incontinence has been the golden standard. Treatment with PTNS (percutaneous tibial nerve stimulation) has been showed to produce healing of chronic anal fissures not responding to topical treatment, thus avoiding the risk for debilitating anal incontinence.
详细描述
This study will prospectively include 52 patients with chronic anal fissure that have received topical treatment and stool softeners and have all been evaluated by experienced proctological surgeons. The treatment will be given for 10 consecutive work days and then evaluated at 3 and 12 months. If the patients symptoms are unimproved at 3 months alternative treatments will be offered.
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
- •Verified anal fissure (Clinical assessement by experienced proctological surgeon)
- •Full conservative treatment has been given
排除标准
- •Inflammatory bowel disease
- •Fistula and/or anal abscess
- •Patients with compromised immunity
- •Pregnancy
- •Treatment with anti-coagulants (not aspirin)
- •Previous irradiation towards pelvic floor
- •Pacemaker or implanted defibrillator
研究组 & 干预措施
PTNS
Treatment with PTNS for chronic anal fissure, treatment to be given for 30 minutes during 10 consecutive work Days.
干预措施: PTNS (Device)
结局指标
主要结局
Healing rate
时间窗: 12 months after treatment
Healing of anal fissure from assessement of clinical and/or data from patient form
次要结局
- Adverse effects(12 months after treatment)
- Smoking(12 months after treatment)
- Bowel movements(12 months after treatment)