Complex Treatment of a Chronic Anal Fissure

January 26, 2022 updated by: State Scientific Centre of Coloproctology, Russian Federation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Astrakhan, Russian Federation
        • Recruiting
        • Astrakhan State Medical University
        • Contact:
          • Kostenko N Vladimirovich, MD
          • Phone Number: +79880784451 +79880784451
          • Email: kostenki@mail.ru
      • Moscow, Russian Federation, 119034
        • Recruiting
        • Medical Center ON-CLINIC
        • Contact:
          • Evgeny A Zagryadsky, phd
          • Phone Number: +79104341786
      • Moscow, Russian Federation, 123423
        • Recruiting
        • SSCCRussia
        • Contact:
          • Sergey A Frolov, phd
          • Phone Number: 89039689739 +79039689739
          • Email: DrZharkow@mail.ru
        • Contact:
      • Moscow, Russian Federation
        • Recruiting
        • City Clinical Hospital №24, Department of Health City of Moscow
        • Contact:
          • Makoev S Nikolaevich, MD
          • Phone Number: +79037983363 +79037983363
          • Email: makoev1972@mail.ru
      • St. Petersburg, Russian Federation
        • Recruiting
        • St. Petersburg State Pavlov Medical University
        • Contact:
          • Demin A Nikolaevich, MD
          • Phone Number: 89213374143 89213374143
          • Email: dan-7691@mail.ru
      • Tomsk, Russian Federation
        • Recruiting
        • Siberian State Medical University
        • Contact:
    • MO
      • Podolsk, MO, Russian Federation, 142155
        • Recruiting
        • GBUZ MO "Lvovskaia Raionaia Bolnica"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xeomin
Complex treatment of chronic anal fissure with drug-induced relaxation of the internal sphincter with Botulinum Toxin Type A. (IncobotulinumtoxinA 50 U Intramuscular Powder for Solution).
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.

Other Names:
  • Xeomin
Active Comparator: Xeomin control
Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy.
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 lumen, and the internal sphincter is dissected up to the wall of the anal canal mucosa under the control of the finger inserted into the anal canal. After controlling hemostasis, the operation is ended with the introduction of the vent tube and hemostatic sponge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anal sphincter insufficiency
Time Frame: Up to 60 days
Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence).
Up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-item pain intensity (P2)
Time Frame: On day 7, 30 and 60
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).
On day 7, 30 and 60
Non-Healing Wound
Time Frame: On day 60
Frequency of post-operative wound epithelialization
On day 60
Profilometry /sphincterometry findings
Time Frame: On day 30 and 60
Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
On day 30 and 60
Temporary disability
Time Frame: Up to 60 days
Duration of temporary disability
Up to 60 days
Relap
Time Frame: Up to 60 days
Frequency of relapses
Up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Collaborators

St. Petersburg State Pavlov Medical University
Astrakhan State Medical University
Siberian State Medical University
City Clinical Hospital №24, Department of Health City of Moscow
GBUZ MO "Lvovskaia Raionaia Bolnica"
Medical Center ON-CLINIC

Investigators

  • Principal Investigator: Sergey A. Frolov, Ph.D., State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56IG701SSCC978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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