Chronic anal fissure
Conditions
Interventions
Randomisation (injection into the external anal sphincter or to the internal anal sphincter), endoanal ultrasound
Sponsors
UMCG
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment efficacy estimated via healing rate and no long-term recurrance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameter(s): - 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. - changes of anorectal physiology will be approached using the anorectal physiology tests - the socioeconomic efficiency (including QoL) will be evaluated using the EuroQoL-5D-5L and iMSQ instruments. All the secondary outcomes will be measured on a short and long term (8-10 weeks and 12 months after treatment, respectively). | — |
Contacts
Public ContactMonika Trzpis
University of Groningen, University Medical Center Groningen
Outcome results
None listed