Optimaal gebruik van Botuline toxine voor efficiënte behandeling van chronische anale fissure
- Conditions
- Chronic anal fissure
- Registration Number
- NL-OMON20571
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 150
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment efficacy estimated via healing rate and no long-term recurrance.
- Secondary Outcome Measures
Name Time Method Secondary study parameter(s):<br>- safety of the treatment, defined by side effects known from previous studies (temporary: incontinence for flatus, soiling, fecal incontinence), will be approached using de DeFeC questionnaire and anamneses. <br>- changes of anorectal physiology will be approached using the anorectal physiology tests<br>- the socioeconomic efficiency (including QoL) will be evaluated using the EuroQoL-5D-5L and iMSQ instruments.<br>All the secondary outcomes will be measured on a short and long term (8-10 weeks and 12 months after treatment, respectively).