Complex Treatment of a Chronic Anal Fissure

State Scientific Centre of Coloproctology, Russian Federation

Status and phase: Enrolling; Phase 4

Conditions: Fissure in Ano

Treatments: Procedure: Lateral subcutaneous sphincterotomy.; Drug: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03855046

56IG701SSCC978

Details and patient eligibility

About

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

Full description

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).

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic anal fissure

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Xeomin

Experimental group

Description:

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).

Treatment:

Drug: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution

Xeomin control

Active Comparator group

Description:

Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy.

Treatment:

Procedure: Lateral subcutaneous sphincterotomy.