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Clinical Trials/NL-OMON20571
NL-OMON20571
Not yet recruiting
Not Applicable

Targeted injections of BOTULin toxin in either the INternal or EXternal anal sphincter (BOTULINEX): a randomized, double-blind, multi-center study in 150 patients with chronic anal fissure.

MCG0 sites150 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic anal fissure
Sponsor
MCG
Enrollment
150
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
MCG

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • \-\=18 years old
  • \-have chronic anal fissure
  • \-are referred for treatment with botulin toxin injections for treatment of CAF
  • \-understand Dutch language
  • \-sign inform consent

Exclusion Criteria

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • \-no given inform consent
  • \-mental retardation
  • \-severe operations in the region of anal sphincter, which might impair the function of the internal or external anal sphincter.
  • \-any disease altering function of anal sphincter, including Hirschsprung disease, anorectal malformations, diabetes myelitis and peripheral neuropathy
  • \-pregnancy

Outcomes

Primary Outcomes

Not specified

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