Complex Treatment of a Chronic Anal Fissure

Phase 4

Recruiting

• Conditions: Fissure in Ano
• Interventions: Procedure: Lateral subcutaneous sphincterotomy.; Drug: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution

• Registration Number: NCT03855046
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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).

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Study Start: 2019-09-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-09-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xeomin control	Lateral subcutaneous sphincterotomy.	Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy.
Xeomin	IncobotulinumtoxinA 50 U Intramuscular Powder for Solution	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).

Primary Outcome Measures

Name	Time	Method
Anal sphincter insufficiency	Up to 60 days	Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).

Secondary Outcome Measures

Name	Time	Method
Relap	Up to 60 days	Frequency of relapses
2-item pain intensity (P2)	On day 7, 30 and 60	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).
Non-Healing Wound	On day 60	Frequency of post-operative wound epithelialization
Profilometry /sphincterometry findings	On day 30 and 60	Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Temporary disability	Up to 60 days	Duration of temporary disability

Trial Locations

Locations (7)

GBUZ MO "Lvovskaia Raionaia Bolnica"; 🇷🇺 Podolsk, MO, Russian Federation

Astrakhan State Medical University; 🇷🇺 Astrakhan, Russian Federation

SSCCRussia; 🇷🇺 Moscow, Russian Federation

City Clinical Hospital №24, Department of Health City of Moscow; 🇷🇺 Moscow, Russian Federation

Medical Center ON-CLINIC; 🇷🇺 Moscow, Russian Federation

St. Petersburg State Pavlov Medical University; 🇷🇺 St. Petersburg, Russian Federation

Siberian State Medical University; 🇷🇺 Tomsk, Russian Federation