Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure Without Excision
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Anal sphincter insufficiency
研究概览
简要总结
This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.
详细描述
A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and able-bodied adults, so the issue of treatment is of particular relevance.
The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed.
Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency).
In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early post-operative period.
Botulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic anal fissure with spasm of anal sphincter
排除标准
- •Inflammatory diseases of the colon
- •Pectenosis
- •Previous surgical interventions on the anal canal
- •IV grade internal and external hemorrhoids
- •Rectal fistula
- •Severe somatic diseases at the decompensation stage
- •Pregnancy and lactation
- •Anal sphincter insufficiency
- •Chronic paraproctitis
- •Fibrous polyp of the anal canal, accompanied by clinical manifestations
- •Individual intolerance and hypersensitivity to botulinum toxin
- •Myasthenia gravis and myasthenic syndromes
结局指标
主要结局
Anal sphincter insufficiency
时间窗: Up to 60 days
Frequency of anal sphincter insufficiency according to the Wexner scale
次要结局
- 2-item pain intensity (P2)(On day 7, 30 and 60)
- Profilometry /sphincterometry findings(On day 30, 60 and 365)
- Relap(Up to 60 days)
- Temporary disability(Up to 60 days)
- Non-Healing Wound(On day 15, 30, 45, 60)
