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Clinical Trials/NCT01584752
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

Sponsor
Central Finland Hospital District
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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