Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Status Terminated

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01584752
Study type	Observational [Patient Registry]
Source	Central Finland Hospital District
Contact
Status	Terminated
Phase
Start date	November 2011
Completion date	November 2015

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