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Clinical Trials/ISRCTN97413456
ISRCTN97413456
Completed
N/A

Open comparative randomized clinical study of the influence of Botulinum Toxin Type A injection vs. anal dilatation with inflatable balloon in patients after chronic anal fissure excision on the frequency and duration of following anal sphincter insufficiency.

State Scientific Centre of Coloproctology0 sites52 target enrollmentNovember 22, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic anal fissure
Sponsor
State Scientific Centre of Coloproctology
Enrollment
52
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Registry
who.int
Start Date
November 22, 2018
End Date
September 2, 2019
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
State Scientific Centre of Coloproctology

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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