Gore-BioA Fistula Plug to Treat Transsphincteric Fistulas

Terminated

• Conditions: Anal Fistula; Fecal Incontinence; Surgery

• Registration Number: NCT01584752
• Lead Sponsor: Central Finland Hospital District

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Primary Completion: 2014-12
• Study Completion: 2015-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing of the fistula	6 months

Secondary Outcome Measures

Name	Time	Method
Symptoms of fecal incontinence	6 months

Trial Locations

Locations (4)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Central Hospital; 🇫🇮 Seinäjoki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Turku University Hospital; 🇫🇮 Turku, Finland