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Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05598164
Acronym
BTATCAF
Enrollment
140
Registered
2022-10-28
Start date
2022-09-01
Completion date
2025-05-01
Last updated
2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

OTHERBotulinum toxin type A

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.

Sponsors

State Scientific Centre of Coloproctology, Russian Federation
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anal sphincter insufficiencyUp to 60 daysFrequency of anal sphincter insufficiency according to the Wexner scale

Secondary

MeasureTime frameDescription
2-item pain intensity (P2)On day 7, 30 and 60Self 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).
Non-Healing WoundOn day 15, 30, 45, 60Frequency of post-operative wound epithelialization
Profilometry /sphincterometry findingsOn day 30, 60 and 365Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Temporary disabilityUp to 60 daysDuration of temporary disability
RelapUp to 60 daysFrequency of relapses

Countries

Russia

Contacts

Primary ContactEvgeny E. Zharkov, MD
drzharkov@mail.ru+79039689739
Backup ContactKarina I. Sagidova, MD
karinaibakovna@mail.ru+79894543916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026