Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Central Finland Hospital District60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anal Fistula Fecal Incontinence Surgery

Interventions

Gore-BioA Fistula PlugPROCEDURE

Gore-BioA Fistula Plug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (7)

Helsinki University Hospital

Helsinki, Finland

Central Hospital

Joensuu, Finland

Central Hospital

Jyväskylä, Finland

Central Hospital

Lahti, Finland

Outcomes

Primary Outcomes

Healing of the fistula

Time frame: 6 months

Secondary Outcomes

Symptoms of fecal incontinence

Time frame: 6 months

Data from ClinicalTrials.gov

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