Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

Not Applicable

Recruiting

• Conditions: Chronic Anal Fissure

• Registration Number: NCT05598164
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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).

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28
• Primary Completion: 2023-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anal sphincter insufficiency	Up to 60 days	Frequency of anal sphincter insufficiency according to the Wexner scale

Secondary Outcome Measures

Name	Time	Method
Non-Healing Wound	On day 15, 30, 45, 60	Frequency of post-operative wound epithelialization
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).
Profilometry /sphincterometry findings	On day 30, 60 and 365	Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Relap	Up to 60 days	Frequency of relapses
Temporary disability	Up to 60 days	Duration of temporary disability

Trial Locations

Locations (1)

SSCCRussia; 🇷🇺 Moscow, Russian Federation