NCT01584752

Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Clinical Multicenter Study of the Efficacy of Gore-BioA Fistula Plug in High Transsphincteric Perianal Fistulas

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Central Finland Hospital District · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Fistula
• Fecal Incontinence
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Gore-BioA Fistula Plug	Gore-BioA Fistula Plug

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-12-01
• Completion: 2015-11-01
• First posted: 2012-04-25
• Last updated: 2019-07-26

Locations

7 sites across 1 country: Finland