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
ConditionsChronic anal fissure
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.
Investigators
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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