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Chronic Anal FissureBTATCAFNCT05598164

Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

A study testing Botulinum toxin type A in people with Chronic Anal Fissure, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Anal Fissure
What is being tested?
Botulinum toxin type A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteRussia
Study dates
1 Sep 2022to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with chronic anal fissure with spasm of anal sphincter

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Evgeny E. Zharkov, MD contact

+79039689739

drzharkov@mail.ru

Karina I. Sagidova, MD contact

+79894543916

karinaibakovna@mail.ru

Russia1 site, 1 recruiting

  • SSCCRussia

    Moscow, 123423

    Sergey A Frolov, phd, +79039689739 ext. 89039689739, DrZharkow@mail.ru

    Evgeny E Zharkov, +79039689739 ext. +79039689739, drzharkov@mail.ru

    Recruiting

Other trials in Russia

About this study

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

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

Read the 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).

Keywords
Fissure in Ano, Anal fissure, botulinum toxin A, Chronic anal pain, Fecal incontinence, Spasm of the internal sphincter, Anal sphincter insufficiency
Medical subject headings
Fissure in Ano, Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type AOther

    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.

Study groups in NCT05598164
Study groupRoleWhat they receive
main groupExperimentalPatients of main group are treated with injection in internal sphincter Botulinum toxin type A.
Receives: Other: Botulinum toxin type A
control groupExperimentalIn the control group, the fissure is excised in combination with a injection in internal sphincter Botulinum toxin type A.
Receives: Other: Botulinum toxin type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anal sphincter insufficiency

    Frequency of anal sphincter insufficiency according to the Wexner scale

    Measured: Up to 60 days

Secondary outcomes (5)

  1. 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).

    Measured: On day 7, 30 and 60

  2. Non-Healing Wound

    Frequency of post-operative wound epithelialization

    Measured: On day 15, 30, 45, 60

  3. Profilometry /sphincterometry findings

    Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry

    Measured: On day 30, 60 and 365

  4. Temporary disability

    Duration of temporary disability

    Measured: Up to 60 days

  5. Relap

    Frequency of relapses

    Measured: Up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2022
  2. Study start1 Sep 2022
  3. Primary completion1 May 2023 (estimated)
  4. Study completion1 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment A comparative, randomized, prospective, single-center clinical study. Patients of the 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 with excision.
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05598164
Sponsor's protocol ID
56IG701SSCC979
Acronym
BTATCAF
Status last verified
Sep 2022
First submitted
25 Oct 2022
Last updated
28 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8351556

  • Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.

    PubMed 8416784

  • 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.

    PubMed 22336789

  • 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.

    PubMed 10528760

  • 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.

    PubMed 1511644

  • 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.

    PubMed 24500725

  • 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.

    PubMed 22430300

  • 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.

    PubMed 27539490

  • 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.

    PubMed 7934496

  • 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.

    PubMed 27926552

Questions about this trial

What is this clinical trial studying?

A study testing Botulinum toxin type A in people with Chronic Anal Fissure, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Evgeny E. Zharkov, MD (+79039689739, drzharkov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anal sphincter insufficiency (time frame: Up to 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05598164, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.

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