Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

Chronic Anal Fissure Clinical Trial

— BTATCAF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598164
• Other study ID #: 56IG701SSCC979
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: September 2022
• Source: State Scientific Centre of Coloproctology, Russian Federation
• Contact: Evgeny E. Zharkov, MD
• Phone: +79039689739
• Email: drzharkov[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Anal Fissure
• Fissure in Ano

Intervention

Other:
• Botulinum 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.

Locations

Country	Name	City	State
Russian Federation	SSCCRussia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (10)

Bobkiewicz A, Francuzik W, Krokowicz L, Studniarek A, Ledwosinski W, Paszkowski J, Drews M, Banasiewicz T. Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis. World J Surg. 2016 Dec;40(12):3064-3072. doi: 10.1007/s00268-016-3693-9. Review. Erratum in: World J Surg. 2016 Dec;40(12 ):3063. — View Citation

Chen HL, Woo XB, Wang HS, Lin YJ, Luo HX, Chen YH, Chen CQ, Peng JS. Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure: a meta-analysis of randomized control trials. Tech Coloproctol. 2014 Aug;18(8):693-8. doi: 10.1007/s10151-014-1121-4. Epub 2014 Feb 6. Review. — View Citation

Delechenaut P, Leroi AM, Weber J, Touchais JY, Czernichow P, Denis P. Relationship between clinical symptoms of anal incontinence and the results of anorectal manometry. Dis Colon Rectum. 1992 Sep;35(9):847-9. — View Citation

Gui D, Cassetta E, Anastasio G, Bentivoglio AR, Maria G, Albanese A. Botulinum toxin for chronic anal fissure. Lancet. 1994 Oct 22;344(8930):1127-8. — View Citation

Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. — View Citation

Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. Review. — View Citation

Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003431. doi: 10.1002/14651858.CD003431.pub3. Review. — View Citation

Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. — View Citation

Valizadeh N, Jalaly NY, Hassanzadeh M, Kamani F, Dadvar Z, Azizi S, Salehimarzijarani B. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012 Oct;397(7):1093-8. doi: 10.1007/s00423-012-0948-2. Epub 2012 Mar 20. — View Citation

Zetterström J, Mellgren A, Jensen LL, Wong WD, Kim DG, Lowry AC, Madoff RD, Congilosi SM. Effect of delivery on anal sphincter morphology and function. Dis Colon Rectum. 1999 Oct;42(10):1253-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anal sphincter insufficiency	Frequency of anal sphincter insufficiency according to the Wexner scale	Up to 60 days
Secondary	2-item pain intensity (P2)	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).	On day 7, 30 and 60
Secondary	Non-Healing Wound	Frequency of post-operative wound epithelialization	On day 15, 30, 45, 60
Secondary	Profilometry /sphincterometry findings	Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry	On day 30, 60 and 365
Secondary	Temporary disability	Duration of temporary disability	Up to 60 days
Secondary	Relap	Frequency of relapses	Up to 60 days