Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Central Finland Hospital District

Status: Terminated

Conditions: Surgery; Fecal Incontinence; Anal Fistula

Treatments: Procedure: Gore-BioA Fistula Plug

Study type: Observational

Funder types: Other

Identifiers

NCT01584752

KSSHP1U/2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Fistula patients

Description:

Gore-BioA Fistula Plug

Treatment:

Procedure: Gore-BioA Fistula Plug