Treatment of Chronic Anal Fissure with Ultrasound-Guided Inter-Sphincteric Injections of Botulinum Toxin A
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- VAS scale to quantify pain. Wesner scale to assess fecal incontinence It is a 20-point scale FIQL (Fecal Incontinence Quallity of Life) scale of quality of life, in cases of incontinence. Measurement of the thickness of the EAI by endorectal ultrasound
研究概览
简要总结
To assess whether the technique of ultrasound-guided botulinum toxin infiltration is more effective and safer than the standard technique, by controlling the infiltration sites. The aim is to analyze whether the location of the botulinum toxin infiltration is an important factor in the result of the treatment. percentage to assess whether the botulinum toxin infiltration is more effective and safer than the standard one. On the other hand, the aim is to standardize a technique and make it much more precise for the localization of the infiltration, through the use of the endorectal ultrasound probe. Therefore, our objective is to establish a novel technique that complements the standard technique, is reproducible and does not increase the risks and is even safer, as it controls the site of toxin infiltration.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •All patients of legal age who sign the informed consent form and are diagnosed with chronic anal fissure will be included in the study. Chronic anal fissure will be considered to be that which has been evolving for more than 6 weeks, despite various hygienic-dietary and/or relaxing treatments (NTG) or calcium blockers and which macroscopically presents any of the aspects of chronicity referred to: indurated edges, observation in the fundus of IAF fibers and/or sentinel polyp that persists for more than 6 weeks.
排除标准
- •Patients in whom botulinum toxin injection is contraindicated are excluded from the study: patients with alterations of neuromuscular transmission such as myasthenia gravis, Lambert Eaton myasthenic syndrome, inflammatory bowel disease, concomitant treatment with aminoglycosides, pregnancy or lactation, asthma or adverse reactions to treatment.
结局指标
主要结局
VAS scale to quantify pain. Wesner scale to assess fecal incontinence It is a 20-point scale FIQL (Fecal Incontinence Quallity of Life) scale of quality of life, in cases of incontinence. Measurement of the thickness of the EAI by endorectal ultrasound
VAS scale to quantify pain. Wesner scale to assess fecal incontinence It is a 20-point scale FIQL (Fecal Incontinence Quallity of Life) scale of quality of life, in cases of incontinence. Measurement of the thickness of the EAI by endorectal ultrasound
次要结局
未报告次要终点
研究者
Jorge Labrador
Scientific
Hospital Universitario de Burgos