Anal Fistula, Fecal Incontinence, Surgery
Conditions
Brief summary
This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months
Detailed description
Inclusion criteria for the study is a patient with ultrasound or MRI proven high transsphincteric perianal fistula. Patients with Crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. A Seton is placed in the fistula track for two months before the application of the plug. Patients are followed up for six months. Symptoms of fecal incontinence before and after intervention are monitored with the Cleveland clinic incontinence score.
Interventions
PROCEDUREGore-BioA Fistula Plug
Gore-BioA Fistula Plug
Sponsors
Central Finland Hospital District
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 years, male or female * High cryptoglandular perianal fistula * Written approval for the study * Sufficient co-operation for the study * Localization of the fistula by ultrasound or MRI
Exclusion criteria
* Crohns disease * Immunosuppressive treatment * Anovaginal fistula * Radiation therapy 6 months before study * Chemotherapy 6 months before study * Low- or intersphincteric fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of the fistula | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms of fecal incontinence | 6 months |
Countries
Finland
Outcome results
None listed