Clinical trial NCT05598164: Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
Official title: Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure Without Excision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Anal Fissure
Keywords: Fissure in Ano
Anal fissure
botulinum toxin A
Chronic anal pain
Fecal incontinence
Spasm of the internal sphincter
Anal sphincter insufficiency
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2022-10-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Anal sphincter insufficiency
timeFrame: Up to 60 days
Secondary outcomes:
measure: 2-item pain intensity (P2)
timeFrame: On day 7, 30 and 60
measure: Non-Healing Wound
timeFrame: On day 15, 30, 45, 60
measure: Profilometry /sphincterometry findings
timeFrame: On day 30, 60 and 365
measure: Temporary disability
timeFrame: Up to 60 days
measure: Relap
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: SSCCRussia
Study officials:
affiliation: State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
name: Sergey A. Frolov, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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