Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

Study Overview
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Brief Summary
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This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

Detailed Description
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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).

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

Conditions
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Chronic Anal Fissure

Intervention / Treatment
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* Other: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic anal fissure with spasm of anal sphincter Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment A comparative, randomized, prospective, single-center clinical study. Patients of the main group are treated with injection in internal sphincter Botulinum toxin type A. In the control group, the fissure is excised in combination with a injection in internal sphincter Botulinum toxin type A with excision.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: main group<br>Patients of main group are treated with injection in internal sphincter Botulinum toxin type A. | Other: Botulinum toxin type A<br>* Patients of main group are treated with injection in internal sphincter botulinum toxin type A. In the control group, the fissure is excised in combination with a injection in internal sphincter botulinum toxin type A.<br>|
| Experimental: control group<br>In the control group, the fissure is excised in combination with a injection in internal sphincter Botulinum toxin type A. | Other: Botulinum toxin type A<br>* Patients of main group are treated with injection in internal sphincter botulinum toxin type A. In the control group, the fissure is excised in combination with a injection in internal sphincter botulinum toxin type A.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal sphincter insufficiency | Frequency of anal sphincter insufficiency according to the Wexner scale | Up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-item pain intensity (P2) | Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be). | On day 7, 30 and 60 | 
| Non-Healing Wound | Frequency of post-operative wound epithelialization | On day 15, 30, 45, 60 | 
| Profilometry /sphincterometry findings | Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry | On day 30, 60 and 365 | 
| Temporary disability | Duration of temporary disability | Up to 60 days | 
| Relap | Frequency of relapses | Up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fissure in Ano, Anal fissure, botulinum toxin A, Chronic anal pain, Fecal incontinence, Spasm of the internal sphincter, Anal sphincter insufficiency