Menu
Recruiting NCT03855046

Complex Treatment of a Chronic Anal Fissure

Phase IV Interventional Fissure in Ano

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IncobotulinumtoxinA 50 U Intramuscular Powder for Solution, Lateral subcutaneous sphincterotomy..
Who it may be relevant to
Registry conditions: Fissure in Ano. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Comparative Efficacy and Safety Study of Lateral Subcutaneous Sphincterotomy and Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure

Overview

This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.

Detailed description

Chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. This condition is attended by severe pain syndrome during and after bowel movement (defecation). This condition is most frequent in younger and working-age adults; therefore, the treatment issue is of particular relevance.

The main cause of chronic anal fissure development is spasm of the internal sphincter. It should be eliminated in the first instance, in order to provide the 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 complex 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).

Interventions

  • Drug IncobotulinumtoxinA 50 U Intramuscular Powder for Solution
    Sparing surgical removal of fissure without internal sphincter incision is held under spinal anesthesia in surgical room at lithotomy position using electrocoagulation. After that Botulinum Toxin Type A is injected into the internal anal sphincter at 1, 5, 7 and 11 o'clock (localization of injection points), 10 U at each point (40 U in total). Botulinum toxin type A (a 50 U vial) is diluted with 1.0 ml of 0.9% saline solution.
  • Procedure Lateral subcutaneous sphincterotomy.
    The patient is positioned on the table like for perineal lithotomy. After spinal anesthesia, the anal canal and then the surgical field are treated with 70% ethanol. Under the rectal speculum control, sparing surgical removal of fissure without internal sphincter incision is held using electrocoagulation.Then, in a 3 or 9 o'clock position, a narrow (eye) scalpel is inserted into the intersphincteric groove separating the external and internal sphincters, the scalpel blade is turned to the rectal

Primary outcome measures

  • Anal sphincter insufficiency [Time frame: Up to 60 days]
Secondary outcome measures (5)
  • 2-item pain intensity (P2) [Time frame: On day 7, 30 and 60]
  • Non-Healing Wound [Time frame: On day 60]
  • Profilometry /sphincterometry findings [Time frame: On day 30 and 60]
  • Temporary disability [Time frame: Up to 60 days]
  • Relap [Time frame: Up to 60 days]

Eligibility criteria

Inclusion criteria

  • Patients with chronic anal fissure

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
  • Individual intolerance and hypersensitivity to botulinum toxin
  • Myasthenia gravis and myasthenia-like syndromes
  • Anal sphincter insufficiency

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 7 centers
  • GBUZ MO "Lvovskaia Raionaia Bolnica" — Podolsk
  • Astrakhan State Medical University — Astrakhan
  • Medical Center ON-CLINIC — Moscow
  • SSCCRussia — Moscow
  • City Clinical Hospital №24, Department of Health City of Moscow — Moscow
  • St. Petersburg State Pavlov Medical University — Saint Petersburg
  • Siberian State Medical University — Tomsk

Publications

  • 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
  • Sohn N, Eisenberg MM, Weinstein MA, Lugo RN, Ader J. Precise anorectal sphincter dilatation--its role in the therapy of anal fissures. Dis Colon Rectum. 1992 Apr;35(4):322-7. doi: 10.1007/BF02048108. PMID 1582352
  • Renzi A, Izzo D, Di Sarno G, Talento P, Torelli F, Izzo G, Di Martino N. Clinical, manometric, and ultrasonographic results of pneumatic balloon dilatation vs. lateral internal sphincterotomy for chronic anal fissure: a prospective, randomized, controlled trial. Dis Colon Rectum. 2008 Jan;51(1):121-7. doi: 10.1007/s10350-007-9162-7. Epub 2007 Dec 15. PMID 18080713
  • 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
  • Khan M.I., Khan H., Khan A.U., et. al. Comparing the efficacy of botulinum toxin injection and lateral internal sphincterotomy for chronic anal fissure. KJMS, 2016. 9(1): p. 6
  • 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
  • Nasr M, Ezzat H, Elsebae M. Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. World J Surg. 2010 Nov;34(11):2730-4. doi: 10.1007/s00268-010-0736-5. PMID 20703472
  • 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

Identifiers

NCT: NCT03855046 · 56IG701SSCC978

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗