NCT01584752TerminatedNot Applicable
Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas
Central Finland Hospital District4 sites in 1 country60 target enrollmentStarted: November 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Healing of the fistula
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Healing of the fistula
Time Frame: 6 months
Secondary Outcomes
- Symptoms of fecal incontinence(6 months)
Investigators
Study Sites (4)
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