Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure
NCT ID: NCT05598164
Last Updated: 2022-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2022-09-01
2025-05-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
In the control group, the fissure is excised in combination with a injection in internal sphincter Botulinum toxin type A with excision.
TREATMENT
NONE
Study Groups
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main group
Patients of main group are treated with injection in internal sphincter Botulinum toxin type A.
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.
control group
In the control group, the fissure is excised in combination with a injection in internal sphincter Botulinum toxin type A.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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State Scientific Centre of Coloproctology, Russian Federation
OTHER_GOV
Responsible Party
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Principal Investigators
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Sergey A. Frolov, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)
Locations
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SSCCRussia
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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References
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Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. doi: 10.1097/00007611-199308000-00016.
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
Zetterstrom 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. doi: 10.1007/BF02234209.
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. doi: 10.1007/BF02047871.
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.
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.
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.
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. doi: 10.1016/s0140-6736(94)90633-5.
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. doi: 10.1097/DCR.0000000000000735. No abstract available.
Other Identifiers
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56IG701SSCC979
Identifier Type: -
Identifier Source: org_study_id
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