The treatment of chronic anal fissures with fissure excision and Botulinum Toxin Type A injectio

Not Applicable

Completed

• Conditions: Chronic anal fissure; Digestive System

• Registration Number: ISRCTN97413456
• Lead Sponsor: State Scientific Centre of Coloproctology

Brief Summary

2020 Results article in https://doi.org/10.33878/2073-7556-2020-19-1-80-99 results (added 01/04/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-22
• Study Completion: 2019-09-02
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Aged 18-70 years old
2. Chronic anal fissure

Exclusion Criteria

1. Inflammatory disease of the colon
2. Pectenosis
3. Previous surgical interventions of the anal canal
4. II-IV grade internal haemorrhoids
5. Rectal fistula
6. Severe somatic diseases at the decompensation stage
7. Pregnancy
8. Lactation
9. Intolerance or hypersensitivity to Botulinum toxin
10. Myasthenia gravis and myasthenia-like syndromes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of anal sphincter insufficiency, assessed using the Wexner score 60 days after surgery.