Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anal Fistula Fecal Incontinence Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Fistula patients

Gore-BioA Fistula Plug

Intervention Type PROCEDURE

Gore-BioA Fistula Plug

Interventions

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Gore-BioA Fistula Plug

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No