Botulinum Toxin Type A in the Treatment of Chronic Anal Fissure (BTATCAF)

October 25, 2022 updated by: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

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
      • Moscow, Russian Federation, 123423
        • Recruiting
        • SSCCRussia
        • Contact:
          • Sergey A Frolov, phd
          • Phone Number: 89039689739 +79039689739
          • Email: DrZharkow@mail.ru
        • 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 with spasm of anal sphincter

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
  • 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

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

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.
Experimental: control group
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

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.

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
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
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
Non-Healing Wound
Time Frame: On day 15, 30, 45, 60
Frequency of post-operative wound epithelialization
On day 15, 30, 45, 60
Profilometry /sphincterometry findings
Time Frame: On day 30, 60 and 365
Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
On day 30, 60 and 365

Collaborators and Investigators

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

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

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, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56IG701SSCC979

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

No

Studies a U.S. FDA-regulated device product

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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