Clinical trial NCT03855046: Complex Treatment of a Chronic Anal Fissure
Official title: A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Fissure in Ano
Keywords: Internal sphincterotomy
Anal fissure
Chronic anal fissure
botulinum toxin A
proctologic diseases
surgical treatment
Chronic anal pain
Fecal incontinence
Spasm of the internal sphincter
Anal sphincter insufficiency
randomized
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
Collaborators: name: St. Petersburg State Pavlov Medical University
name: Astrakhan State Medical University
name: Siberian State Medical University
name: City Clinical Hospital №24, Department of Health City of Moscow
name: GBUZ MO "Lvovskaia Raionaia Bolnica"
name: Medical Center ON-CLINIC
First posted: 2019-02-26
Enrollment: 340
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: A multicenter, prospective, randomized, controlled clinical study. Surgical removal of anal fissure followed by internal sphincter relaxation with Botulinum toxin type A is performed in the study group.

Lateral subcutaneous sphincterotomy to relax sphincter is a method of choice in the control group. Patients are randomized with envelope method
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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

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 60
measure: Profilometry /sphincterometry findings
timeFrame: On day 30 and 60
measure: Temporary disability
timeFrame: Up to 60 days
measure: Relap
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Podolsk
country: Russian Federation
facility: GBUZ MO "Lvovskaia Raionaia Bolnica"
state: MO
city: Astrakhan
country: Russian Federation
facility: Astrakhan State Medical University
city: Moscow
country: Russian Federation
facility: Medical Center ON-CLINIC
city: Moscow
country: Russian Federation
facility: SSCCRussia
city: Moscow
country: Russian Federation
facility: City Clinical Hospital №24, Department of Health City of Moscow
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Pavlov Medical University
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
Study officials:
affiliation: State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
name: Sergey A. Frolov, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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