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临床试验/NCT05598164
NCT05598164Unknown不适用

Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure Without Excision

State Scientific Centre of Coloproctology, Russian Federation2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2022年9月1日最近更新:
适应症

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

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)

研究者

发起方
State Scientific Centre of Coloproctology, Russian Federation
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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