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临床试验/NCT03855046
NCT03855046招募中4 期

A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

State Scientific Centre of Coloproctology, Russian Federation7 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
340
试验地点
7
主要终点
Anal sphincter insufficiency

研究概览

简要总结

This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.

详细描述

Chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. This condition is attended by severe pain syndrome during and after bowel movement (defecation). This condition is most frequent in younger and working-age adults; therefore, the treatment issue is of particular relevance.

The main cause of chronic anal fissure development is spasm of the internal sphincter. It should be eliminated in the first instance, in order to provide the 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 complex 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

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
  • Individual intolerance and hypersensitivity to botulinum toxin
  • Myasthenia gravis and myasthenia-like syndromes
  • Anal sphincter insufficiency

研究组 & 干预措施

Xeomin

Experimental

Complex treatment of chronic anal fissure with drug-induced relaxation of the internal sphincter with Botulinum Toxin Type A. (IncobotulinumtoxinA 50 U Intramuscular Powder for Solution).

干预措施: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution (Drug)

Xeomin control

Active Comparator

Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy.

干预措施: Lateral subcutaneous sphincterotomy. (Procedure)

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 incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).

次要结局

  • 2-item pain intensity (P2)(On day 7, 30 and 60)
  • Relap(Up to 60 days)
  • Non-Healing Wound(On day 60)
  • Profilometry /sphincterometry findings(On day 30 and 60)
  • Temporary disability(Up to 60 days)

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 (7)

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