Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas

This is a prospective clinical study on the efficacy of Gore-BioA fistula plug in high transsphincteric fistulas. Follow-up time is six months

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.

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