Combined Method of Surgical Treatment of Anal Fissure

NCT07268261 | Recruiting

• 1 other identifier: 56IG701SSCC980
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.

Conditions

Chronic Anal Fissure

Keywords

Fissure in Ano; Anal fissure; botulinum toxin A; Chronic anal pain; Fecal incontinence; Spasm of the internal sphincter; Anal sphincter insufficiency

Outcome Measures

Primary Outcomes (1)

• Anal sphincter insufficiency

  Frequency of anal sphincter insufficiency according to the Wexner scale

  60 days

Secondary Outcomes (5)

• 2-item pain intensity (P2)

  On day 15, 30, 45 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 the main group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each)

Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A

control group

EXPERIMENTAL

Patients in the control group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each)

Procedure: excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A

Interventions

excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A PROCEDURE

patients undergo excision of the fissure in combination with drug relaxation of the internal sphincter with botulinum toxin type A at a dosage of 40 units of action; an additional injection of platelet-rich plasma is added

control group; main group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Individual intolerance and hypersensitivity to botulinum toxin
• Myasthenia gravis and myasthenic syndromes
• History of allergic reaction to anticoagulants.
• Blood diseases (thrombocytopenia, splenomegaly, etc.)

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

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: 8351556 BACKGROUND

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

  PMID: 8416784 BACKGROUND

• 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: 22336789 BACKGROUND

• 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: 10528760 BACKGROUND

• 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: 1511644 BACKGROUND

• 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: 24500725 BACKGROUND

• 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: 22430300 BACKGROUND

• 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: 27539490 BACKGROUND

• 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: 7934496 BACKGROUND

• 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: 27926552 BACKGROUND

MeSH Terms

Conditions

Fissure in Ano; Fecal Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological 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

+79039689739; drzharkov@mail.ru

Ekaterina Yu. Lebedeva

CONTACT

+79779558920; katerina.lebedeva.1997@mail.ru

Study Design

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

Model Details: Parallel assignment. Comparative, randomized, prospective, single-center. clinical trial. Patients in the main group undergo excision of the fissure in combination with injection into internal sphincter Botulinum toxin type A In the control group, excision of the fissure was performed in combination with injection into internal sphincter Botulinum toxin type A with excision in combination with platelet rich plasma

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 5, 2025
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)