NCT05598164

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

October 28, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

October 25, 2022

Last Update Submit

October 25, 2022

Conditions

Chronic Anal Fissure

Keywords

Fissure in AnoAnal fissurebotulinum toxin AChronic anal painFecal incontinenceSpasm of the internal sphincterAnal sphincter insufficiency

Outcome Measures

Primary Outcomes (1)

  • Anal sphincter insufficiency

    Frequency of anal sphincter insufficiency according to the Wexner scale

    Up to 60 days

Secondary Outcomes (5)

  • 2-item pain intensity (P2)

    On day 7, 30 and 60

  • Non-Healing Wound

    On day 15, 30, 45, 60

  • Profilometry /sphincterometry findings

    On day 30, 60 and 365

  • Temporary disability

    Up to 60 days

  • Relap

    Up to 60 days

Study Arms (2)

main group

EXPERIMENTAL

Patients of main group are treated with injection in internal sphincter Botulinum toxin type A.

Other: Botulinum toxin type A

control group

EXPERIMENTAL

In the control group, the fissure is excised in combination with a injection in internal sphincter Botulinum toxin type A.

Other: Botulinum toxin type A

Interventions

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.

control groupmain group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic anal fissure with spasm of anal sphincter

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSCCRussia

Moscow, 123423, Russia

RECRUITING

Related Publications (10)

  • 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.

    PMID: 8351556BACKGROUND

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

    PMID: 8416784BACKGROUND

  • 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.

    PMID: 22336789BACKGROUND

  • 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.

    PMID: 10528760BACKGROUND

  • 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.

    PMID: 1511644BACKGROUND

  • 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.

    PMID: 24500725BACKGROUND

  • 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.

    PMID: 22430300BACKGROUND

  • 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.

    PMID: 27539490BACKGROUND

  • 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.

    PMID: 7934496BACKGROUND

  • 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.

    PMID: 27926552BACKGROUND

MeSH Terms

Conditions

Fissure in AnoFecal Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Sergey A. Frolov, Ph.D.

    State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evgeny E. Zharkov, MD

CONTACT

+79039689739drzharkov@mail.ru

Karina I. Sagidova, MD

CONTACT

+79894543916karinaibakovna@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

September 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2025

Last Updated

October 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)